A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

Phase 2

Terminated

• Conditions: Painful Diabetic Neuropathy
• Interventions: Drug: GRT3938Y; Drug: Placebo

• Registration Number: NCT01056315
• Lead Sponsor: Grünenthal GmbH

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-21
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2012-04-05
• Results First Submitted QC: 2012-04-05
• Results First Posted: 2012-05-03
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-09
• Last Update Posted: 2019-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 553

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A GRT3983Y	GRT3938Y	Participants randomly assigned to receive GRT3983Y.
B Placebo	Placebo	Participants randomly assigned to placebo.

Primary Outcome Measures

Name	Time	Method
Average Pain Intensity	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (61)

Site 127; 🇺🇸 Fairhope, Alabama, United States

Site 130; 🇺🇸 Homewood, Alabama, United States

Site 112; 🇺🇸 Tucson, Arizona, United States

Site 129; 🇺🇸 Escondido, California, United States

Site 209; 🇺🇸 Fullerton, California, United States

Site 135; 🇺🇸 Long Beach, California, United States

Site 202; 🇺🇸 Northridge, California, United States

Site 208; 🇺🇸 Northridge, California, United States

Site 219; 🇺🇸 Northridge, California, United States

Site 203; 🇺🇸 San Francisco, California, United States

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