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A Trial in Painful Diabetic P...

A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

Last Updated: 2019-10-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

553 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Painful Diabetic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A GRT3983Y

Participants randomly assigned to receive GRT3983Y.

Group Type EXPERIMENTAL

GRT3938Y

Intervention Type DRUG

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

B Placebo

Participants randomly assigned to placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Overencapsulated tablets of placebo, 16 weeks treatment.

Interventions

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GRT3938Y

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

Intervention Type DRUG

Placebo

Overencapsulated tablets of placebo, 16 weeks treatment.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Grünenthal GmbH

Locations

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Site 127

Fairhope, Alabama, United States

Site Status

Site 130

Homewood, Alabama, United States

Site Status

Site 112

Tucson, Arizona, United States

Site Status

Site 129

Escondido, California, United States

Site Status

Site 209

Fullerton, California, United States

Site Status

Site 135

Long Beach, California, United States

Site Status

Site 202

Northridge, California, United States

Site Status

Site 208

Northridge, California, United States

Site Status

Site 219

Northridge, California, United States

Site Status

Site 203

San Francisco, California, United States

Site Status

Site 116

Santa Ana, California, United States

Site Status

Site 118

Santa Ana, California, United States

Site Status

Site 121

Santa Ana, California, United States

Site Status

Site 133

Santa Ana, California, United States

Site Status

Site 126

Vista, California, United States

Site Status

Site 214

Vista, California, United States

Site Status