Clinical trial NCT01056315: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Painful Diabetic Neuropathy
Keywords: Analgesia
Diabetic Neuropathy
Neuropathic pain
Painful
Chronic pain
Lead sponsor: Grünenthal GmbH
Sponsor class: INDUSTRY
First posted: 2010-01-26
Enrollment: 553
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Average Pain Intensity
timeFrame: Baseline; last 7 days of 12-week maintenance
Secondary outcomes:
measure: Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over the Entire 12-week Maintenance
timeFrame: Baseline, Daily scores over entire 12 week maintenance
measure: 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).
timeFrame: Baseline, Last 7 days of 12-week maintenance
measure: Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over Each Week of Maintenance.
timeFrame: Baseline; daily scores over each week of maintenance
measure: Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS).
timeFrame: Baseline; weekly mean
measure: Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively.
timeFrame: Baseline, weekly mean
measure: 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).
timeFrame: Baseline, weekly mean
measure: 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)
timeFrame: Baseline, weekly mean
measure: Patient Global Impression of Change Using a 7-point Verbal Rating Scale, on Day 29, Day 71 and Day 113 (Final Visit).
timeFrame: Day 29, Day 71 and Day 113.
measure: Short Form 36 Health Survey (SF-36®): Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
timeFrame: Baseline, Day 29, Day 71 and Day 113.
measure: EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
timeFrame: Baseline, Day 29, Day 71 and Day 113.
measure: Assessment of Each Item of the Leeds Sleep Evaluation Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
timeFrame: Baseline, Day 29, Day 71 and Day 113.
measure: Hospital Anxiety and Depression Scale: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).
timeFrame: Baseline, Day 29, Day 71 and Day 113.
measure: Time to Treatment Discontinuation Due to Lack of Efficacy.
timeFrame: Baseline to time to treatment discontinuation
measure: Assessment of Rescue Medication Usage During the 4-week Titration.
timeFrame: 4-week titration phase
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Site 127
state: Alabama
city: Homewood
country: United States
facility: Site 130
state: Alabama
city: Tucson
country: United States
facility: Site 112
state: Arizona
city: Escondido
country: United States
facility: Site 129
state: California
city: Fullerton
country: United States
facility: Site 209
state: California
city: Long Beach
country: United States
facility: Site 135
state: California
city: Northridge
country: United States
facility: Site 202
state: California
city: Northridge
country: United States
facility: Site 208
state: California
city: Northridge
country: United States
facility: Site 219
state: California
city: San Francisco
country: United States
facility: Site 203
state: California
city: Santa Ana
country: United States
facility: Site 116
state: California
city: Santa Ana
country: United States
facility: Site 118
state: California
city: Santa Ana
country: United States
facility: Site 121
state: California
city: Santa Ana
country: United States
facility: Site 133
state: California
city: Vista
country: United States
facility: Site 126
state: California
city: Vista
country: United States
facility: Site 214
state: California
city: Waterbury
country: United States
facility: Site 201
state: Connecticut
city: Deerfield Beach
country: United States
facility: Site 136
state: Florida
city: Deerfield Beach
country: United States
facility: Site 137
state: Florida
city: Deerfield Beach
country: United States
facility: Site 140
state: Florida
city: Deerfield Beach
country: United States
facility: Site 216
state: Florida
city: Deerfield Beach
country: United States
facility: Site 217
state: Florida
city: Deerfield Beach
country: United States
facility: Site 218
state: Florida
city: Fort Myers
country: United States
facility: Site 117
state: Florida
city: Jacksonville
country: United States
facility: Site 124
state: Florida
city: Jupiter
country: United States
facility: Site 228
state: Florida
city: Orlando
country: United States
facility: Site 101
state: Florida
city: Orlando
country: United States
facility: Site 226
state: Florida
city: Sarasota
country: United States
facility: Site 206
state: Florida
city: West Palm Beach
country: United States
facility: Site 212
state: Florida
city: Atlanta
country: United States
facility: Site 142
state: Georgia
city: Chicago
country: United States
facility: Site 128
state: Illinois
city: Chicago
country: United States
facility: Site 223
state: Illinois
city: Leawood
country: United States
facility: Site 114
state: Kansas
city: Paducah
country: United States
facility: Site 102
state: Kentucky
city: Baltimore
country: United States
facility: Site 211
state: Maryland
city: East Bridgewater
country: United States
facility: Site 108
state: Massachusetts
city: Las Vegas
country: United States
facility: Site 113
state: Nevada
city: Princeton
country: United States
facility: Site 122
state: New Jersey
city: New York
country: United States
facility: Site 230
state: New York
city: Rochester
country: United States
facility: Site 109
state: New York
city: Asheville
country: United States
facility: Site 225
state: North Carolina
city: High Point
country: United States
facility: Site 115
state: North Carolina
city: Canton
country: United States
facility: Site 227
state: Ohio
city: Cincinnati
country: United States
facility: Site 233
state: Ohio
city: Toledo
country: United States
facility: Site 111
state: Ohio
city: Toledo
country: United States
facility: Site 125
state: Ohio
city: Philadelphia
country: United States
facility: Site 104
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site 106
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site 205
state: Pennsylvania
city: Austin
country: United States
facility: Site 105
state: Texas
city: Corpus Christi
country: United States
facility: Site 213
state: Texas
city: Houston
country: United States
facility: Site 110
state: Texas
city: Houston
country: United States
facility: Site 123
state: Texas
city: Houston
country: United States
facility: Site 204
state: Texas
city: Houston
country: United States
facility: Site 210
state: Texas
city: Houston
country: United States
facility: Site 231
state: Texas
city: San Antonio
country: United States
facility: Site 131
state: Texas
city: San Antonio
country: United States
facility: Site 215
state: Texas
city: San Antonio
country: United States
facility: Site 221
state: Texas
city: Provo
country: United States
facility: Site 139
state: Utah
Study officials:
affiliation: Grünenthal GmbH
name: Study Director
role: STUDY_DIRECTOR
References: