A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

October 9, 2019 updated by: Grünenthal GmbH

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

553

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Fairhope, Alabama, United States
        • Site 127
      • Homewood, Alabama, United States
        • Site 130
    • Arizona
      • Tucson, Arizona, United States
        • Site 112
    • California
      • Escondido, California, United States
        • Site 129
      • Fullerton, California, United States
        • Site 209
      • Long Beach, California, United States
        • Site 135
      • Northridge, California, United States
        • Site 202
      • Northridge, California, United States
        • Site 208
      • Northridge, California, United States
        • Site 219
      • San Francisco, California, United States
        • Site 203
      • Santa Ana, California, United States
        • Site 116
      • Santa Ana, California, United States
        • Site 118
      • Santa Ana, California, United States
        • Site 121
      • Santa Ana, California, United States
        • Site 133
      • Vista, California, United States
        • Site 126
      • Vista, California, United States
        • Site 214
    • Connecticut
      • Waterbury, Connecticut, United States
        • Site 201
    • Florida
      • Deerfield Beach, Florida, United States
        • Site 136
      • Deerfield Beach, Florida, United States
        • Site 137
      • Deerfield Beach, Florida, United States
        • Site 140
      • Deerfield Beach, Florida, United States
        • Site 216
      • Deerfield Beach, Florida, United States
        • Site 217
      • Deerfield Beach, Florida, United States
        • Site 218
      • Fort Myers, Florida, United States
        • Site 117
      • Jacksonville, Florida, United States
        • Site 124
      • Jupiter, Florida, United States
        • Site 228
      • Orlando, Florida, United States
        • Site 101
      • Orlando, Florida, United States
        • Site 226
      • Sarasota, Florida, United States
        • Site 206
      • West Palm Beach, Florida, United States
        • Site 212
    • Georgia
      • Atlanta, Georgia, United States
        • Site 142
    • Illinois
      • Chicago, Illinois, United States
        • Site 128
      • Chicago, Illinois, United States
        • Site 223
    • Kansas
      • Leawood, Kansas, United States
        • Site 114
    • Kentucky
      • Paducah, Kentucky, United States
        • Site 102
    • Maryland
      • Baltimore, Maryland, United States
        • Site 211
    • Massachusetts
      • East Bridgewater, Massachusetts, United States
        • Site 108
    • Nevada
      • Las Vegas, Nevada, United States
        • Site 113
    • New Jersey
      • Princeton, New Jersey, United States
        • Site 122
    • New York
      • New York, New York, United States
        • Site 230
      • Rochester, New York, United States
        • Site 109
    • North Carolina
      • Asheville, North Carolina, United States
        • Site 225
      • High Point, North Carolina, United States
        • Site 115
    • Ohio
      • Canton, Ohio, United States
        • Site 227
      • Cincinnati, Ohio, United States
        • Site 233
      • Toledo, Ohio, United States
        • Site 111
      • Toledo, Ohio, United States
        • Site 125
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Site 104
      • Philadelphia, Pennsylvania, United States
        • Site 106
      • Philadelphia, Pennsylvania, United States
        • Site 205
    • Texas
      • Austin, Texas, United States
        • Site 105
      • Corpus Christi, Texas, United States
        • Site 213
      • Houston, Texas, United States
        • Site 110
      • Houston, Texas, United States
        • Site 123
      • Houston, Texas, United States
        • Site 204
      • Houston, Texas, United States
        • Site 210
      • Houston, Texas, United States
        • Site 231
      • San Antonio, Texas, United States
        • Site 131
      • San Antonio, Texas, United States
        • Site 215
      • San Antonio, Texas, United States
        • Site 221
    • Utah
      • Provo, Utah, United States
        • Site 139

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A GRT3983Y
Participants randomly assigned to receive GRT3983Y.
Drug: GRT3938Y
Overencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment.
PLACEBO_COMPARATOR: B Placebo
Participants randomly assigned to placebo.
Drug: Placebo
Overencapsulated tablets of placebo, 16 weeks treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline; last 7 days of 12-week maintenance

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over the Entire 12-week Maintenance
Time Frame: Baseline, Daily scores over entire 12 week maintenance
Baseline, Daily scores over entire 12 week maintenance
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).
Time Frame: Baseline, Last 7 days of 12-week maintenance
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.
Time Frame: Baseline; daily scores 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).
Time Frame: Baseline; weekly mean
Baseline; weekly mean
Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively.
Time Frame: Baseline, weekly mean
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).
Time Frame: Baseline, weekly mean
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)
Time Frame: Baseline, weekly mean
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).
Time Frame: Day 29, Day 71 and Day 113.
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).
Time Frame: Baseline, Day 29, Day 71 and Day 113.
Baseline, Day 29, Day 71 and Day 113.
EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
Time Frame: Baseline, Day 29, Day 71 and Day 113.
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).
Time Frame: Baseline, Day 29, Day 71 and Day 113.
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).
Time Frame: Baseline, Day 29, Day 71 and Day 113.
Baseline, Day 29, Day 71 and Day 113.
Time to Treatment Discontinuation Due to Lack of Efficacy.
Time Frame: Baseline to time to treatment discontinuation
Baseline to time to treatment discontinuation
Assessment of Rescue Medication Usage During the 4-week Titration.
Time Frame: 4-week titration phase
4-week titration phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grünenthal GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

December 21, 2009

First Submitted That Met QC Criteria

January 25, 2010

First Posted (ESTIMATE)

January 26, 2010

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2019

Last Update Submitted That Met QC Criteria

October 9, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131885

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Painful Diabetic Neuropathy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe