NCT01332149
Completed
Phase 3
An 11-week Randomized, Double-blind, Multi Center, Placebo-controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (300 Mg/Day) Using A Fixed Dosing Schedule In The Treatment Of Subjects S With Pain Associated With Diabetic Peripheral Neuropathy.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.30 sites in 1 country626 target enrollmentStarted: July 2011Last updated:
ConditionsDiabetic Neuropathy, Painful
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Enrollment
- 626
- Locations
- 30
- Primary Endpoint
- Baseline Mean Pain Score
Overview
Brief Summary
Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.
This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female subjects aged 18 years or older
- •Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6 months to 5 years (inclusive).
- •At the baseline and randomization visits, a score of ≥50 mm on the Visual Analogue Scale, at randomization, subjects must have completed at least 5 daily pain interference diaries, and have an average daily pain score of ≥5 over the past 7 days.
- •Patient who are willing and capable to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Women of childbearing potential are willing to use contraception during study.
Exclusion Criteria
- •Subjects with more than 30% decrease on the Pain Visual Analog Scale at randomization as compared to screening; and during the 1 week screening period, with more than one pain score \<3 in pain scores.
- •Subject has other kinds of neurological disorder, pain of other reason, or skin condition that could confuse the assessment.
- •Subject with any other serious or unstable condition which in the opinion of the investigator might compromise participation in the study.
Arms & Interventions
300 mg/day pregabalin (Lyrica)
Experimental
Patient take pregabalin capsule twice a day
Intervention: Pregabalin (Drug)
Placebo
Placebo Comparator
Intervention: Placebo matched with pregabalin (Drug)
Outcomes
Primary Outcomes
Baseline Mean Pain Score
Time Frame: Baseline
The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
Change From Baseline in Mean Pain Score at Endpoint
Time Frame: Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.
Secondary Outcomes
- Percentage of 30 Percent (%) Responders at Endpoint(End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9(Baseline and weekly from Weeks 1 to 9)
- Baseline Mean Sleep Interference Score(Baseline)
- Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale(Baseline)
- Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Patient Global Impression of Change (PGIC) Score at Endpoint(Day 63 (Week 9)/Early Termination (Study Endpoint))
- Percentage of Participants Who Had Optimal Sleep at Endpoint(Day 63 (Week 9)/Early Termination (Study Endpoint))
- Clinical Global Impression of Change (CGIC) at Endpoint(Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9(Baseline and weekly from Weeks 1 to 9)
- Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Baseline Hospital Anxiety and Depression Scale (HADS) Scores(Baseline)
- Change From Baseline in HADS Depression Total Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in Mean Sleep Interference Score at Endpoint(Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in HADS Anxiety Total Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9(Baseline; Weeks 1, 5, and 9)
- Change From Baseline in Pain VAS From the SF-MPQ at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in PPI Scale From the SF-MPQ at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores(Baseline)
Investigators
Study Sites (30)
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