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NCT Number: NCT01709214

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

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.

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Key information

Conditions

Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee Arthritis Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Joint Diseases Lung Diseases Lung Diseases, Obstructive Musculoskeletal Diseases Neurologic Manifestations Organizing Pneumonia Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Rheumatic Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 022, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cebranopadol (GRT6005) Low-Dose Range

Drug

Capsules

Cebranopadol (GRT6005) High-Dose Range

Drug

Capsules

Placebo

Drug

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

Oxycodone CR

Drug

Capsules containing oxycodone CR 10 or 20 milligrams

Primary outcomes

  1. Change from baseline in the weekly average of the daily average pain rating

    Time frame: Baseline to end of treatment (Week 15)

Secondary outcomes

  1. Change from baseline in the physical function subscale of the Western Ontario and McMaster University Index of Osteoarthritis Questionnaire (WOMAC)

    Time frame: Baseline to end of treatment (Week 15)

Sponsors and collaborators

Lead sponsor

Tris Pharma, Inc.

Industry

Collaborators

  • Forest Laboratories

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 18, 2012
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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