Trial name or title

A global, multicenter, randomised, double‐blind, placebo controlled study comparing the safety and efficacy of ABT‐894, duloxetine and placebo in subjects with diabetic neuropathic pain

Methods

Randomised, double‐blind, placebo control, single group assignment, safety/efficacy study. Phase II

Participants

Male and female 18 to 75

Inclusion criteria:

• The subject must have a diagnosis of diabetes mellitus (type 1 or type 2) and a diagnosis of diabetic neuropathic pain (DNP).

• Subject's DNP must be present for a minimum of six months and should have begun in the feet with relatively symmetrical onset.

• Subject has an HgbA1c ≤ 9. Subjects who have an HgbA1c > 9 and ≤ 11 may be included in the study.

Interventions

Drug: ABT‐894, 1 mg, 2 mg, 4 mg twice daily
Drug: placebo
Drug: duloxetine 60 mg

Outcomes

Primary outcome measures:

• Efficacy of each ABT‐894 dose (1 mg, 2 mg or 4 mg BID) versus placebo in the treatment of pain due to DNP (time frame: change from baseline to final 24‐hour average pain score)

Secondary outcome measures:

• Proportions of treatment responders; subjects who complete treatment period with 30% improvement (time frame: from baseline to final 24‐hour average pain score)

• Mean of 24‐hour worst pain severity, average of night pain, and average of morning pain measured by the 11‐point Likert scale and from subject's daily diary (time frame: weekly through treatment phase)

• Brief Pain Inventory (BPI) (short form) including pain severity (time frame: at each visit from baseline to week 8 visit)

• Clinician Global Impression: Severity (CGIS) and Patient Global Impression: Change (PGIC) (time frame: at each visit from baseline to week 8 visit) 

Starting date

July 2007 to October 2008

Contact information

Wolfram Nothaft, MD Abbott

Notes

Completed

Trial name or title

A phase 2a, randomised, double‐blind, placebo‐ and active‐controlled, parallel‐group, multicenter study to assess the safety and efficacy of ADL5859 100 mg BID in subjects with neuropathic pain associated with diabetic peripheral neuropathy

Methods

Phase II randomised, double blind, parallel assignment, safety/efficacy study

Participants

Male and female subjects between 18 and 75 years of age. Diabetes mellitus (type I or II) that is documented to be under stable glycaemic control over a period of at least 3 months, as indicated by a HbgAIc of ≤ 12% and a stable dose of insulin or oral diabetic medication for 90 days prior to starting study medication. Evidence of symmetrical, bilateral pain in the lower extremities due to diabetic peripheral neuropathy (DPN). Presence of daily pain due to DPN for at least 3 months. Score ≥ 3 on the physical examination portion of the Michigan Neuropathy Screening Instrument (MNSI). Average weekly pain score of ≥ 4 on the numeric pain rating scale (NPRS) for symmetrical neuropathic pain in the feet and legs

Interventions

Drug: ADL5859
Drug: duloxetine
Drug: placebo

Outcomes

Primary outcome measures:

• Change from baseline in mean pain intensity score (NPRS) (time frame: week 4)

Secondary outcome measures:

• Change from baseline in the mean NPRS proportion of subjects with 30% reduction in average pain score. (weekly)

• Patient Global Impression of Change (PGIC) (time frame: week 4)

• Change in Sleep Interference Scale (SIS) from baseline (time frame: week 4)

• Change from baseline in the evening assessment of the 24‐hour overall mean pain intensity score (time frame: weekly)

• Change from baseline in NPRS at rest in the clinic (time frame: weekly)

• Change from baseline in NPRS after walking 50 feet in the clinic (time frame: weekly)

Starting date

November 2007. Completed August 2008

Contact information

Bruce Berger Adolor Corporation

Exton Office
700 Pennsylvania Drive
Exton, PA 19341
(484) 595‐1500

Notes

Trial name or title

Pilot study of use of duloxetine for the treatment of phantom limb pain

Methods

Non‐randomised, open label, uncontrolled, single group assignment, safety/efficacy study

Participants

Male or female 18 to 75 years

1. Chronic phantom limb pain > 6 months

2. Short‐Form McGill Pain Questionnaire Sensory Pain Rating Index raw score >16

3. Age >18 years old

4. Inpatient or outpatient

5. Able to come to all appointments

6. Able to give informed consent

Interventions

Duloxetine

Outcomes

Primary outcome measure

• McGill Short Form Pain Questionnaire

Secondary outcome measures:

• Fiser Side Effect Scale

• visual analogue pain scale

• Present Pain Intensity

• Paracetamol

Starting date

January to June 2007

Contact information

Asif Chaudhry, MD 713‐798‐7999 ext 96363

Ken Woods 713‐791‐1414 ext 2247

Notes

Completed

Trial name or title

A comparison of strategies for switching patients from amitriptyline to duloxetine for the management of diabetic peripheral neuropathic pain

Methods

Phase IV

Participants

Male or female 18 years or over. Diagnosed with diabetic peripheral neuropathic pain, taking the same dose of amitriptyline once daily at bedtime for at least four weeks. Stable glycaemic control

Interventions

Duloxetine switch from amitriptyline

Outcomes

Primary outcome measures:

• Subscale of the UKU side effect rating scale to be measured during the switch period. The weeks during which the switch occurs are blinded

Secondary outcome measures:

• Daily: 24 hour average pain, worst pain, night pain; non steroidal anti‐inflammatory and paracetamol use

• Weekly: Leeds Sleep Evaluation Questionnaire, Brief Profile of Mood States, Clinical Global Impression of Severity. Visits 2, 7, 11: Treatment Satisfaction Questionnaire for Medic

Starting date

2005 completed 2007

Contact information

Eli Lilly and Company 1‐877‐CTLILLY (1‐877‐285‐4559) or 1‐317‐615‐4559

Notes

Completed but not published

Trial name or title

Duloxetine versus placebo in the treatment of patients with diabetic peripheral neuropathic pain in China

Methods

Phase 3 randomised, double‐blind (subject, caregiver, investigator, outcomes assessor), placebo control, parallel assignment, safety/efficacy study

Participants

Male or female, 18 to 75, pain due to bilateral peripheral neuropathy caused by type I or type II diabetes with the pain beginning in the feet and present for at least 6 months. Score of 4 or greater on the Brief Pain Inventory on the 24‐hour average pain item

Interventions

Duloxetine 60 mg daily for 12 weeks

Outcomes

Primary outcome measures:

• Brief Pain Inventory 24‐hour average pain score (efficacy of duloxetine 60 to 120 mg daily)

Secondary outcome measures:

• BPI worst pain, least pain, and current pain severity and average of 7 interference scores

• Clinical Global Impression of Severity

• Patient Global Impression of Improvement

• EuroQoL Questionnaire ‐ 5 dimensions

• Discontinuation rates

• Tolerability of morning versus evening dosing, spontaneously reports adverse events

• Athens Insomnia Scale 8‐item and 5‐item

• Adverse events

• Vital signs

• Laboratory measures

Starting date

December 2006 to February 2008

Contact information

Eli Lilly and Company 1‐877‐CTLILLY (1‐877‐285‐4559) or 1‐317‐615‐4559 Mon‐Fri 9 AM ‐ 5 PM Eastern time UTC/GMT ‐ 5 hours, EST

Notes

Closed and completed

Trial name or title

Maintenance of effect of duloxetine 60 mg once daily in patients with diabetic peripheral neuropathic pain

Methods

Phase IV open label, uncontrolled, single group assignment, safety/efficacy study

Participants

Male or female 18 years or older. Have pain due to bilateral peripheral neuropathy caused by type I or type II diabetes with the pain beginning in the feet and present for at least 6 months. Score of 4 or greater on the Brief Pain Inventory (BPI) on the 24‐hour average pain item

Interventions

All subjects receive duloxetine 30 mg daily, orally for 1 week followed by duloxetine 60 mg daily, orally for 7 weeks, then maintenance at 60 mg daily, orally for responders to 6 months and rescue at 120 mg daily, orally for non‐responders to 6 months

Outcomes

Primary outcome measures:

• BPI 24‐hour average pain item score, maintenance effect of duloxetine 60 mg in patients with diabetic peripheral neuropathic pain, who achieve 30% pain reduction at 8 weeks

Secondary outcome measures:

• BPI 24‐hour average pain item, percentage of patients with a ≥ 50% reduction from visit 2 (time frame: over 8 weeks and 6 months)

• BPI severity and interference item scores (time frame: over 8 weeks and 6 months)

• Patient's Global Impressions of Improvement (time frame: over 8 weeks and 6 months)

• Clinical Global Impressions of Severity (time frame: over 8 weeks and 6 months)

• Sensory portion of the Short‐Form McGill Pain Questionnaire (time frame: over 8 weeks and 6 months)

• Discontinuation rates (time frame: over 8 weeks and 6 months) (designated as safety issue: yes)

• Treatment‐emergent adverse events (time frame: over 8 weeks and 6 months)

• Vital signs (time frame: over 8 weeks and 6 months)

Starting date

April 2006 to October 2007

Contact information

Eli Lilly and Company 1‐877‐CTLILLY (1‐877‐285‐4559) or 1‐317‐615‐4559 Mon‐Fri 9 AM ‐ 5 PM Eastern time UTC/GMT ‐ 5 hours, EST

Notes

Completed but publication status unclear

Trial name or title

A 1‐year safety study of duloxetine in patients with fibromyalgia syndrome

Methods

Phase III randomised, double‐blind, dose comparison, parallel assignment, safety study

Participants

Male or female 18 years or older who meet criteria for primary fibromyalgia syndrome as defined by the American College of Rheumatologists

Interventions

Duloxetine ? dose

Outcomes

Primary outcome measure:

• Evaluate safety and efficacy of duloxetine in patients diagnosed with fibromyalgia syndrome

Secondary outcome measures:

• Evaluate persistence of efficacy

• Evaluate long‐term differences in efficacy in different doses

• Evaluate gains in efficacy in non‐responders

Starting date

July 2005 completed March 2007

Contact information

Eli Lilly and Company

1‐877‐CTLILLY(1‐877‐285‐4559) OR 1‐317‐615‐4559

Notes

Completed publication status unclear

Trial name or title

A superiority study of LY248686 versus placebo in the treatment of patients With diabetic peripheral neuropathic pain

Methods

Randomised, double‐blind (subject, caregiver, investigator, outcomes assessor), placebo control, parallel assignment, safety/efficacy study. Phase III

Participants

Male or female outpatients aged 20 years or older but less than 80 years at the time of consent.

• Patients with pain due to bilateral peripheral neuropathy induced by type 1 or 2 diabetes mellitus. The pain must have been present for at least 6 months and be evaluable in feet, legs, or hands.

• Patients with HbA1c less than or equal to 9.0 percent at visit 1.

• Patients in whom HbA1c had been measured 42‐70 days before visit 1 and subsequent HbA1c levels have been within +/‐ 1.0 percent of the level at visit 1.

• Patients with a mean of the 24‐hour average pain severity scores (round off to a whole number) of 4 or higher, as calculated from the patient diary for 7 days immediately before visit 2

Interventions

Duloxetine 40 mg or 60 mg orally daily versus placebo

Outcomes

Primary outcome measures:

Reduction in average pain severity as measured by an 11‐point Likert scale (Time Frame: 12 weeks)

Secondary outcome measures:

• Pain severity for worst pain and night pain as measured by an 11‐point Likert scale. (time frame: 3 months)

• Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment. (time frame: 3 months) 

• Brief Pain Inventory to measure the severity of pain (time frame: 3 months)

• Beck Depression Inventory‐II (BDI‐II) total score. (time frame: 3 months)

• Safety (time frame: 3.5 months)

Starting date

November 2007 to August 2009

Contact information

Eli Lilly and Company

1‐877‐CTLILLY(1‐877‐285‐4559) OR 1‐317‐615‐4559 Mon‐Fri 9 AM‐5 PM Eastern time (UTC/GMT‐5 hours,EST)

Notes

Recruiting

Trial name or title

An open‐label, randomised comparison of duloxetine, pregabalin, and the combination of duloxetine and gabapentin among patients with inadequate response to gabapentin for the management of diabetic peripheral neuropathic pain

Methods

Randomised, open label, uncontrolled, parallel assignment, safety/efficacy study

Participants

Male or female 18 years or older, diagnosed with diabetic neuropathic pain. Patient has an average daily pain score greater than or equal to 4 on an 11‐point Likert scale, and patient or provider feel that a change from the current gabapentin therapy for pain management is warranted. Patient is currently treated with gabapentin greater than or equal to 900 mg/d, has been prescribed the current dose for at least 4 weeks, and has been at least 80% compliant with dosing, according to patient report. Patient must agree not to change dose of gabapentin between visits 1 and 2. Stable glycaemic control

Interventions

Duloxetine, gabapentin, pregabalin

Outcomes

Primary outcome measure

Mean change from baseline, weekly mean of daily 24 hour average pain score, pregabalin to duloxetine

Secondary outcome measures:

• Mean change from baseline, weekly mean of daily 24‐hour average pain score, duloxetine to duloxetine plus gabapentin

• Mean change from baseline, weekly mean night pain

• Mean change from baseline, Clinical Global Impression of Severity scale (CGI Severity)

• Mean change from baseline, Patient's Global Impression of Improvement scale (PGI ‐ Improvement)

• Mean change from baseline, Brief Pain Inventory (BPI) ‐ severity and interference portions

• Response rate as defined by > 30% reduction in the weekly mean 24 hour average pain score

• Mean change from baseline, Leeds Sleep Evaluation Questionnaire subscales of ease of going to sleep (GTS), awakening (AFS), and behaviour following wakefulness (BFW), quality of sleep (QOS)

• Mean change from baseline, Sheehan Disability Scale (SDS) ‐ total score and items work, family, social, days lost, days underproductive

• Response rate defined by a reduction of > 50% in mean 24 hour average pain score

• Response rate as defined by a > 2‐points reduction on the weekly average of the daily 24‐hour average pain scale

• Summary of Serious Adverse Events and Treatment‐emergent adverse events

• Summary of Adverse Events and Serious Adverse Events leading to discontinuation

• Changes in vital signs and weight including baseline to endpoint abnormal values at any time, and abnormal values at endpoint

• Change in laboratory values, including baseline to endpoint, abnormal values at any time and abnormal values at endpoint

• Mean change in change in Sexual Functioning Questionnaire (CSFQ) total score and subscale scores, categorical change based on total score and subscales (better, same, worse)

• Mean change in change in Sexual Functioning Questionnaire (CSFQ) total score and subscale scores, categorical change based on total score and subscales (better, same, worse)

• Mean change in Portland Neurotoxicity Scale total score, cognitive and somatomotor subscales, categorical change from baseline in total and subscales (better, same, worse)

• Mean change in weekly mean worst pain score

• Mean change in Beck Depression Inventory II (BDI‐II) total score

• Relative contribution of mood states on weekly mean change in 24 hour average pain severity as measured by the Beck Depression Inventory II (BDI‐II) total score path analysis

• Change in percent of patients using health care as measured by the resource utilization scale, individual items 2, 4, 9‐17, 19, 23 will be compared with baseline, categorical analysis for equal, lower or greater utilization

• Summary of overall discontinuation rates

• Time to first ≥ 30% reduction in weekly mean 24 hour average pain score

• Time to first ≥ 50 % reduction in weekly mean 24 hour average pain score

• Time to first sustained response (≥ 30% reduction) in weekly mean 24 hour average pain score

• Time to first ≥ 2 points reduction in weekly mean 24 hour average pain score

• Weekly mean change in 24 hour average pain severity +/‐ GAD

• Per protocol analysis for weekly mean change from baseline in 24 hour average pain severity

• Weekly mean change in 24 hour average pain severity by week by gabapentin exposure subgroup (de novo versus prior use)

• Discontinuations for abnormal laboratory analyses, vital signs, overall and for each measure

Starting date

September 2006 ‐ October 2009

Contact information

Eli Lilly and Company

1‐877‐CTLILLY(1‐877‐285‐4559) OR 1‐317‐615‐4559 Mon‐Fri 9 AM‐5 PM Eastern time (UTC/GMT‐5 hours,EST)

Notes

Recruiting

Trial name or title

Flexible dosed duloxetine versus placebo in the treatment of fibromyalgia

Methods

Phase IV randomised, double‐blind (subject, caregiver, investigator, outcomes assessor), placebo control, parallel assignment, safety/efficacy study

Participants

Male or female patients.

• Aged 18 and older who meet criteria for fibromyalgia as defined by the American College of Rheumatology

• With a score of at least 4 on the average pain item of the BPI (modified short form) at visits 1 and 2

• All females must test negative for pregnancy at the time of enrolment

• A degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator

Interventions

Duloxetine 60 to 120 mg daily for 24 weeks

Outcomes

Primary outcome measure

• Patient's Global Impressions of Improvement (PGII) (time frame: 24 weeks)

Secondary outcome measures:

• Brief Pain Inventory (time frame: 24 weeks)

• Multidimensional Fatigue Inventory (time frame: 24 weeks)

• Beck Depression Inventory‐II (time frame: 24 weeks)

• Clinical Global Impressions of Severity (time frame: 24 weeks)

• Beck Anxiety Inventory (time frame: 24 weeks)

• SF‐36 (Short‐form Health Survey) (time frame: 24 weeks)

• Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (time frame: 24 weeks)

• Anxious Likert Scale (time frame: 24 weeks)

• Sleep Likert Scale (time frame: 24 weeks)

• Pain Likert Scale (time frame: 24 weeks)

• Stiffness Likert Scale (time frame: 24 weeks)

• Mood Likert Scale (time frame: 24 weeks)

• Columbia Suicide Severity Rating Scale (time frame: 24 weeks)

Starting date

June 2008 to February 2010

Contact information

Eli Lilly and Company

1‐877‐CTLILLY(1‐877‐285‐4559) OR 1‐317‐615‐4559 Mon‐Fri 9 AM‐5 PM Eastern time (UTC/GMT‐5 hours,EST)

Notes

Recruiting

Trial name or title

A superiority study of LY248686 versus placebo in the treatment of patients with diabetic peripheral neuropathic pain ‐ extension phase

Methods

Phase III randomised, open label, dose comparison, parallel assignment, safety/efficacy study in Japan

Participants

Male or female 20 to 80 years

Outpatients who have completed the 13‐week treatment in the preceding study (Protocol No.0715N0831). Patients with latest HbA1c ≤ 9.0% before Visit 7

Interventions

Duloxetine 40 mg to 60 mg daily for 1 year

Outcomes

Primary outcome measure:

• Safety (time frame: 1 year)

Secondary outcome measures:

• Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment

• Brief Pain Inventory to measure the severity of pain

• Beck Depression Inventory‐II (BDI‐II) total score

Starting date

March 2008 to February 2010

Contact information

Eli Lilly and Company

1‐877‐CTLILLY(1‐877‐285‐4559) OR 1‐317‐615‐4559 Mon‐Fri 9 AM‐5 PM Eastern time (UTC/GMT‐5 hours,EST)

Notes

Recruiting

Trial name or title

Pilot, open, randomised clinical trial to assess the efficacy of duloxetine in the treatment of fibromyalgy in patients with infection by HIV 1+

Methods

Phase III randomised, open label, active control, parallel assignment, safety/efficacy study

Participants

Male or female

1. Patients aged 18 years old and more .

2. Documented HIV‐1‐infection

3. Former diagnosis of fibromyalgia

4. History of good compliance with visit schedule and medication intake

5. Patients voluntary signed the informed consent

Interventions

Duloxetine 60 mg daily

Outcomes

Primary outcome measure:

• Variation in pain measured using the Brief Pain Inventory questionnaire in both branches of the study (time frame: basal visit, weeks 4, 12, 24, 36 and 48)

Secondary outcome measures:

• Assess differences in Short‐Form 36 Health Survey (SF‐36) questionnaire scale score (time frame: basal visit, weeks 12, 24 and 48)

• Assess differences in Beck Depression Inventory (BDI) questionnaire scale score (time frame: basal visit, weeks 12, 24 and 48)

• Assess differences in Profile of Mood States ‐ Forma A (POMS‐A) questionnaire scale score (time frame: basal visit, weeks 12, 24 and 48)

• Assess the percentage of patients that leave duloxetine due to intolerance or toxicity (time frame: basal visit, weeks 4, 12, 24, 36 and 48)

• Assess, if possible, pharmacokinetic profile of duloxetine and determine interaction with antiretroviral drugs (time frame: basal visit, weeks 4, 12, 24, 36 and 48)

Starting date

January 2007 to December 2009

Contact information

Negredo Eugenia, MD,PhD

Lluita contra la Sida Foundation

Germans Trias i Pujol Hospital

Badalona, Barcelona, Spain, 08916

Notes

Active not recruiting

Trial name or title

A double‐blind, randomised, parallel groups investigation into the effects of pregabalin, duloxetine and amitriptyline on aspects of pain, sleep, and next day performance in patients suffering from diabetic peripheral neuropathy

Methods

Phase II and III randomised, double‐blind, active control, parallel assignment

Participants

Male or female

1. Eighteen years of age or above

2. Have a diagnosis of diabetes mellitus for at least a year

3. Agree not to smoke whilst resident in the CRC

4. Able to understand the patient information sheet and provide written informed consent

5. Score above 12 on the Leeds Assessment of Neuropathic Symptoms and Signs scale (LANSS)

6. Have neuropathic pain of diabetic origin

7. Score above 25 on mini mental state examination (MMSE)

8. Willing to withdraw, under the guidance of their diabetologist, from any current pain medication prior to their first visit to the sleep laboratory. Duration of withdrawal will be at least equivalent to five half‐lives and will be of a relevant duration given the particular medication used

Interventions

Duloxetine, amitriptyline and pregabalin

Outcomes

Primary outcome measures:

• Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory

Secondary outcome measures:

• Whether there has been an improvement in sleep continuity and subjective sleep, morning after cognitive and psychomotor performance, and quality of life (QoL)

Starting date

February 2007 to December 2008

Contact information

Professor AN Nicholson

01483 683719

[email protected]

Notes

Recruiting

Trial name or title

Three way interaction between gabapentin, duloxetine, and donepezil in patients with diabetic neuropathy

Methods

Randomised, double‐blind (subject, investigator, outcomes assessor), parallel assignment

Participants

Male or female. Diagnosis of diabetic neuropathy. Age 18 to 80

Interventions

Group 1: Donepezil 5 mg once per day for 12 weeks. Gabapentin will be added to all groups at week 9.

Group 2: Will receive duloxetine 30 mg twice a day for 12 weeks. Gabapentin will be added to all groups at week 9.

Group 3: Will receive a combination of donepezil 2.5 mg and duloxetine 30mg for 12 weeks. Gabapentin will be added to all groups at week 9.

Group 4: Will receive placebo pills. Gabapentin will be added to all groups at week 9.

Outcomes

Primary outcome measures:

• Pain intensity measurements will be recorded twice daily, using McGill short form pain questionnaire on the handheld computer (PDA). The Visual Analog Pain Scale (VAS) will serve as the primary outcome measure (time frame: study completion (16 weeks))

Starting date

February 2008 to July 2010

Contact information

Regina Curry, RN, CCRC

336‐716‐4294

[email protected]

Wake Forest University Baptist Medical Center

Winston‐Salem, North Carolina, United States, 27157

Notes

Recruiting