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A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

NCT01056315 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 553

Last updated 2019-10-28

Study results available
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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).

Conditions

  • Painful Diabetic Neuropathy

Interventions

DRUG

GRT3938Y

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

DRUG

Placebo

Overencapsulated tablets of placebo, 16 weeks treatment.

Sponsors & Collaborators

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01056315 on ClinicalTrials.gov