A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Analgesic Efficacy and Safety of a New Analgesic Compared to Placebo in Subjects With Painful Diabetic Peripheral Neuropathy

Grünenthal GmbH61 sites in 1 country553 target enrollmentNovember 2009

ConditionsPainful Diabetic Neuropathy

InterventionsGRT3938Y Placebo

DrugsGRT3938Y Placebo

Overview

Phase: Phase 2
Intervention: GRT3938Y
Conditions: Painful Diabetic Neuropathy
Sponsor: Grünenthal GmbH
Enrollment: 553
Locations: 61
Primary Endpoint: Average Pain Intensity
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN).

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

January 2011

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Grünenthal GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Symmetrical painful diabetic peripheral neuropathy

Exclusion Criteria

•History of hypersensitivity, allergy or contraindication to opioids and acetaminophen
•Confounding painful conditions
•Significant vascular disease
•History or risk of seizure
•Chronic disease that might effect drug absorption, distribution, metabolism, or excretion
•Female subjects who are being pregnant or breastfeeding
•Evidence or history of alcohol, medication, or drug abuse

Arms & Interventions

A GRT3983Y

Participants randomly assigned to receive GRT3983Y.

Intervention: GRT3938Y

B Placebo

Participants randomly assigned to placebo.

Intervention: Placebo

Outcomes

Primary Outcomes

Average Pain Intensity

Time Frame: Baseline; last 7 days of 12-week maintenance

The primary efficacy endpoint is the change from baseline in the mean of the daily average pain intensity scores (on an 11-point NRS) over the last 7 days of the 12-week maintenance (Week 16).

Secondary Outcomes

Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over the Entire 12-week Maintenance(Baseline, Daily scores over entire 12 week maintenance)
Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively.(Baseline, weekly mean)
Patient Global Impression of Change Using a 7-point Verbal Rating Scale, on Day 29, Day 71 and Day 113 (Final Visit).(Day 29, Day 71 and Day 113.)
Proportion of Subjects Achieving Various Levels of Pain Improvement (Including 30% and 50%) Based on the Percent Change From Baseline to the Last 7 Days of the 12-week Maintenance on an 11-point NRS (Responder Analysis).(Baseline, Last 7 days of 12-week maintenance)
Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over Each Week of Maintenance.(Baseline; daily scores over each week of maintenance)
Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS).(Baseline; weekly mean)
Brief Pain Inventory Scores: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, and Day 113 (Final Visit).(Baseline, weekly mean)
Neuropathic Pain Symptoms Inventory: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99 and Day 113 (Final Visit)(Baseline, weekly mean)
EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).(Baseline, Day 29, Day 71 and Day 113.)
Short Form 36 Health Survey (SF-36®): Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).(Baseline, Day 29, Day 71 and Day 113.)
Hospital Anxiety and Depression Scale: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).(Baseline, Day 29, Day 71 and Day 113.)
Assessment of Each Item of the Leeds Sleep Evaluation Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).(Baseline, Day 29, Day 71 and Day 113.)
Time to Treatment Discontinuation Due to Lack of Efficacy.(Baseline to time to treatment discontinuation)
Assessment of Rescue Medication Usage During the 4-week Titration.(4-week titration phase)