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

A Randomized, Double-Blind, Placebo- and Active Controlled Study to Evaluate the Safety and Efficacy of GRT6005 in Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01709214

Enrollment

619

Registered

2012-10-18

Start date

2012-12-04

Completion date

2014-04-04

Last updated

2021-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

Keywords

Osteoarthritis, Knee, Pain, Chronic, OA, Arthritis

Brief 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.

Interventions

DRUGCebranopadol (GRT6005) Low-Dose Range

Capsules

DRUGCebranopadol (GRT6005) High-Dose Range

Capsules

DRUGPlacebo

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

DRUGOxycodone CR

Capsules containing oxycodone CR 10 or 20 milligrams

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of osteoarthritis (OA) of the knee * OA knee pain present for at least 3 months * OA knee pain is the predominant (ie, most painful) pain condition * Patients require medication on at least 4 of 7 days per week to treat OA knee pain for at least 1 month. * Dissatisfaction with current OA knee pain treatment and willingness to stop taking all pain medications except for the study drug and allowed rescue medication * Average daily pain rating of at least 5 on a 0 to 10 point numerical rating scale during the 1 week prior to randomization * Female patients either postmenopausal, surgically sterile or practicing a medically acceptable method of contraception * Male patients either status post-bilateral vasectomy or using barrier contraception

Exclusion criteria

* Knee pain due to a disorder other than OA * Other pain that can confound the assessment of, or contribute to, pain at the reference knee * Surgery at the reference knee within 6 months of Screening or a history of joint replacement surgery at the reference knee * Trauma to the reference knee within 6 months of Screening with active symptoms * Steroid injections in the reference knee within 3 months of Screening * Hyaluronic acid injections in the reference knee within 6 months of Screening * Body Mass Index \> 40 kg/m2 * Patient with any protocol-excluded or clinically significant medical, surgical, or medication history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments

Design outcomes

Primary

Measure	Time frame
Change from baseline in the weekly average of the daily average pain rating	Baseline to end of treatment (Week 15)

Secondary

Measure	Time frame
Change from baseline in the physical function subscale of the Western Ontario and McMaster University Index of Osteoarthritis Questionnaire (WOMAC)	Baseline to end of treatment (Week 15)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026