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Assessment of GRT6005 in Painful Osteoarthritis of the Knee

NCT01357837 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2021-07-15

No results posted yet for this study

Summary

The purpose of the trial is to determine whether GRT6005 is effective in patients with pain due to osteoarthritis of the knee.

Conditions

  • Osteoarthritis of the Knee

Interventions

DRUG

Matching Placebo

2 capsules of matching placebo once a day, in the morning, for a total of 28 days

DRUG

GRT6005

2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days

DRUG

GRT6005

2 capsules containing a total of 200 µg GRT6005 once a day, in the morning, for a total of 28 days

DRUG

GRT6005

2 capsules containing a total of 400 µg GRT6005 once a day, in the morning, for a total of 28 days

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Tris Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Jacek Olas, MD · Specjalistyczne Centrum Medyczne NZOZ NOWOMED,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Austria
  • Poland
  • Spain

Study Locations

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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 NCT01357837 on ClinicalTrials.gov