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Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain

NCT01709214 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 619

Last updated 2021-07-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. This study includes a maximum 21 day Screening Period followed by a 15-week Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are eligible for the Double-blind Treatment Period will be randomized to one of following treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range (200, 300 or 400 mcg), oxycodone controlled release (CR) dose range (10, 20, 30, 40 or 50 mg) or placebo.

Conditions

  • Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

Interventions

DRUG

Cebranopadol (GRT6005) Low-Dose Range

Capsules

DRUG

Cebranopadol (GRT6005) High-Dose Range

Capsules

DRUG

Placebo

Capsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules

DRUG

Oxycodone CR

Capsules containing oxycodone CR 10 or 20 milligrams

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Tris Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-04
Primary Completion
2014-04-30
Completion
2014-04-04
FDA Drug
Yes

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 NCT01709214 on ClinicalTrials.gov