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A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

Primary Purpose

Painful Diabetic Neuropathy

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GRT3938Y
Placebo
Sponsored by
Grünenthal GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Painful Diabetic Neuropathy focused on measuring Analgesia, Diabetic Neuropathy, Neuropathic pain, Painful, Chronic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 127
  • Site 130
  • Site 112
  • Site 129
  • Site 209
  • Site 135
  • Site 202
  • Site 208
  • Site 219
  • Site 203
  • Site 116
  • Site 118
  • Site 121
  • Site 133
  • Site 126
  • Site 214
  • Site 201
  • Site 136
  • Site 137
  • Site 140
  • Site 216
  • Site 217
  • Site 218
  • Site 117
  • Site 124
  • Site 228
  • Site 101
  • Site 226
  • Site 206
  • Site 212
  • Site 142
  • Site 128
  • Site 223
  • Site 114
  • Site 102
  • Site 211
  • Site 108
  • Site 113
  • Site 122
  • Site 230
  • Site 109
  • Site 225
  • Site 115
  • Site 227
  • Site 233
  • Site 111
  • Site 125
  • Site 104
  • Site 106
  • Site 205
  • Site 105
  • Site 213
  • Site 110
  • Site 123
  • Site 204
  • Site 210
  • Site 231
  • Site 131
  • Site 215
  • Site 221
  • Site 139

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A GRT3983Y

B Placebo

Arm Description

Participants randomly assigned to receive GRT3983Y.

Participants randomly assigned to placebo.

Outcomes

Primary Outcome Measures

Average Pain Intensity
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

Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over the 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).
Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over Each Week of Maintenance.
Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS).
Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively.
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).
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)
Patient Global Impression of Change Using a 7-point Verbal Rating Scale, on Day 29, Day 71 and Day 113 (Final Visit).
Short Form 36 Health Survey (SF-36®): Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
Assessment of Each Item of the Leeds Sleep Evaluation Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
Hospital Anxiety and Depression Scale: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
Time to Treatment Discontinuation Due to Lack of Efficacy.
Assessment of Rescue Medication Usage During the 4-week Titration.

Full Information

First Posted
December 21, 2009
Last Updated
October 9, 2019
Sponsor
Grünenthal GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01056315
Brief Title
A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Trial was stopped due to difficult enrolment
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grünenthal GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Diabetic Neuropathy
Keywords
Analgesia, Diabetic Neuropathy, Neuropathic pain, Painful, Chronic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
553 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A GRT3983Y
Arm Type
Experimental
Arm Description
Participants randomly assigned to receive GRT3983Y.
Arm Title
B Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomly assigned to placebo.
Intervention Type
Drug
Intervention Name(s)
GRT3938Y
Intervention Description
Overencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Overencapsulated tablets of placebo, 16 weeks treatment.
Primary Outcome Measure Information:
Title
Average Pain Intensity
Description
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).
Time Frame
Baseline; last 7 days of 12-week maintenance
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS).
Time Frame
Baseline; weekly mean
Title
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
Title
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
Title
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
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
Time to Treatment Discontinuation Due to Lack of Efficacy.
Time Frame
Baseline to time to treatment discontinuation
Title
Assessment of Rescue Medication Usage During the 4-week Titration.
Time Frame
4-week titration phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Grünenthal GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Site 127
City
Fairhope
State/Province
Alabama
Country
United States
Facility Name
Site 130
City
Homewood
State/Province
Alabama
Country
United States
Facility Name
Site 112
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Site 129
City
Escondido
State/Province
California
Country
United States
Facility Name
Site 209
City
Fullerton
State/Province
California
Country
United States
Facility Name
Site 135
City
Long Beach
State/Province
California
Country
United States
Facility Name
Site 202
City
Northridge
State/Province
California
Country
United States
Facility Name
Site 208
City
Northridge
State/Province
California
Country
United States
Facility Name
Site 219
City
Northridge
State/Province
California
Country
United States
Facility Name
Site 203
City
San Francisco
State/Province
California
Country
United States
Facility Name
Site 116
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Site 118
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Site 121
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Site 133
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Site 126
City
Vista
State/Province
California
Country
United States
Facility Name
Site 214
City
Vista
State/Province
California
Country
United States
Facility Name
Site 201
City
Waterbury
State/Province
Connecticut
Country
United States
Facility Name
Site 136
City
Deerfield Beach
State/Province
Florida
Country
United States
Facility Name
Site 137
City
Deerfield Beach
State/Province
Florida
Country
United States
Facility Name
Site 140
City
Deerfield Beach
State/Province
Florida
Country
United States
Facility Name
Site 216
City
Deerfield Beach
State/Province
Florida
Country
United States
Facility Name
Site 217
City
Deerfield Beach
State/Province
Florida
Country
United States
Facility Name
Site 218
City
Deerfield Beach
State/Province
Florida
Country
United States
Facility Name
Site 117
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Site 124
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Site 228
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
Site 101
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Site 226
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Site 206
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Site 212
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Site 142
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Site 128
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 223
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 114
City
Leawood
State/Province
Kansas
Country
United States
Facility Name
Site 102
City
Paducah
State/Province
Kentucky
Country
United States
Facility Name
Site 211
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Site 108
City
East Bridgewater
State/Province
Massachusetts
Country
United States
Facility Name
Site 113
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Site 122
City
Princeton
State/Province
New Jersey
Country
United States
Facility Name
Site 230
City
New York
State/Province
New York
Country
United States
Facility Name
Site 109
City
Rochester
State/Province
New York
Country
United States
Facility Name
Site 225
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
Site 115
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
Site 227
City
Canton
State/Province
Ohio
Country
United States
Facility Name
Site 233
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Site 111
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Site 125
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Site 104
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 106
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 205
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 105
City
Austin
State/Province
Texas
Country
United States
Facility Name
Site 213
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
Site 110
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 123
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 204
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 210
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 231
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 131
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Site 215
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Site 221
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Site 139
City
Provo
State/Province
Utah
Country
United States

12. IPD Sharing Statement

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A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

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