NCT01056315|TerminatedPhase 2Results

Study Stopped

Trial was stopped due to difficult enrolment

A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

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 GmbH ClinicalTrials.gov

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1 other identifier

131885

Study Type

interventional

Target

553

Locations

1 country

Sites

Timeline

RegisteredJan 2010

StartedNov 2009

CompletionJan 2011

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).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

553

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2009

Shorter than P25 for phase_2

Geographic Reach

1 country

61 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

November 1, 2009

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2009

Completed

1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

May 3, 2012

Completed

Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

December 21, 2009

Results QC Date

April 5, 2012

Last Update Submit

October 9, 2019

Conditions

Painful Diabetic Neuropathy

Keywords

AnalgesiaDiabetic NeuropathyNeuropathic painPainfulChronic pain

Outcome Measures

Primary Outcomes (1)

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).
Baseline; last 7 days of 12-week maintenance

Secondary Outcomes (14)

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
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
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
+9 more secondary outcomes

Study Arms (2)

A GRT3983Y

EXPERIMENTAL

Participants randomly assigned to receive GRT3983Y.

Drug: GRT3938Y

B Placebo

PLACEBO COMPARATOR

Participants randomly assigned to placebo.

Drug: Placebo

Interventions

GRT3938YDRUG

Overencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment.

A GRT3983Y

PlaceboDRUG

Overencapsulated tablets of placebo, 16 weeks treatment.

B Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Symmetrical painful diabetic peripheral neuropathy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Grünenthal GmbHlead

Study Sites (61)

Site 127

Fairhope, Alabama, United States

Location

Site 130

Homewood, Alabama, United States

Location

Site 112

Tucson, Arizona, United States

Location

Site 129

Escondido, California, United States

Location

Site 209

Fullerton, California, United States

Location

Site 135

Long Beach, California, United States

Location

Site 202

Northridge, California, United States

Location

Site 208

Northridge, California, United States

Location

Site 219

Northridge, California, United States

Location

Site 203

San Francisco, California, United States

Location

Site 116

Santa Ana, California, United States

Location

Site 118

Santa Ana, California, United States

Location

Site 121

Santa Ana, California, United States

Location

Site 133

Santa Ana, California, United States

Location

Site 126

Vista, California, United States

Location

Site 214

Vista, California, United States

Location

Site 201

Waterbury, Connecticut, United States

Location

Site 136