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

Phase 2

Completed

• Conditions: Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
• Interventions: Drug: Oxycodone CR; Drug: Cebranopadol (GRT6005) Low-Dose Range; Drug: Cebranopadol (GRT6005) High-Dose Range; Drug: Placebo

• Registration Number: NCT01709214
• Lead Sponsor: Tris Pharma, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-18
• Study Start: 2012-12-04
• Primary Completion: 2014-04
• Study Completion: 2014-04-04
• Disposition First Submitted: 2019-02-18
• Disposition First Submitted QC: 2019-02-18
• Disposition First Posted: 2019-02-21
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 619

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cebranopadol (GRT6005) Low-Dose Range	Placebo	Once daily GRT6005, flexible dosing 200, 300 or 400 micrograms, and once daily Placebo; oral administration for 15 weeks
Cebranopadol (GRT6005) High-Dose Range	Placebo	Once daily GRT6005, flexible dosing 400, 600 or 800 micrograms, and once daily Placebo; oral administration for 15 weeks
Placebo	Placebo	Twice daily Placebo, oral administration for 15 weeks
Oxycodone CR	Oxycodone CR	Twice daily Oxycodone CR, flexible dosing 10, 20, 30, 40 or 50 milligrams; oral administration for 15 weeks
Cebranopadol (GRT6005) Low-Dose Range	Cebranopadol (GRT6005) Low-Dose Range	Once daily GRT6005, flexible dosing 200, 300 or 400 micrograms, and once daily Placebo; oral administration for 15 weeks
Cebranopadol (GRT6005) High-Dose Range	Cebranopadol (GRT6005) High-Dose Range	Once daily GRT6005, flexible dosing 400, 600 or 800 micrograms, and once daily Placebo; oral administration for 15 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (83)

Site 051; 🇺🇸 Birmingham, Alabama, United States

Site 022; 🇺🇸 Birmingham, Alabama, United States

Site 031; 🇺🇸 Huntsville, Alabama, United States

Site 005; 🇺🇸 Phoenix, Arizona, United States

Site 018; 🇺🇸 Phoenix, Arizona, United States

Site 070; 🇺🇸 Phoenix, Arizona, United States

Site 028; 🇺🇸 Tucson, Arizona, United States

Site 081; 🇺🇸 Chino, California, United States

Site 030; 🇺🇸 El Cajon, California, United States

Site 039; 🇺🇸 Fair Oaks, California, United States

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