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

This study has been completed.
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01709214
First received: October 16, 2012
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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 CR (Controlled Release) dose range (10, 20, 30, 40 or 50 mg) or placebo.


Condition Intervention Phase
Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
Drug: GRT6005 Low-Dose Range
Drug: GRT6005 High-Dose Range
Drug: Placebo
Drug: Oxycodone CR
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change from baseline in the weekly average of the daily average pain rating [ Time Frame: Baseline to end of treatment (Week 15) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 619
Study Start Date: November 2012
Study Completion Date: June 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GRT6005 Low-Dose Range
Once daily GRT6005, flexible dosing 200, 300 or 400 micrograms, oral administration for 15 weeks
Drug: GRT6005 Low-Dose Range
Experimental: GRT6005 High-Dose Range
Once daily GRT6005, flexible dosing 400, 600 or 800 micrograms, oral administration for 15 weeks
Drug: GRT6005 High-Dose Range
Placebo Comparator: Placebo
Once daily GRT6005, flexible dosing 400, 600 or 800 micrograms, oral administration for 15 weeks
Drug: Placebo
Active Comparator: Oxycodone CR
Twice Daily Oxycodone CR, flexible dosing 10, 20, 30, 40 or 50 milligrams, oral administration for 15 weeks
Drug: Oxycodone CR

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709214

  Show 83 Study Locations
Sponsors and Collaborators
Forest Laboratories
Grünenthal GmbH
Investigators
Study Director: Michelle D Finnegan, MPH Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01709214     History of Changes
Other Study ID Numbers: GRT-MD-101
Study First Received: October 16, 2012
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Osteoarthritis
Knee
Pain
Chronic
OA
Arthritis

Additional relevant MeSH terms:
Osteoarthritis
Chronic Pain
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014