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

This study is currently recruiting participants.
Verified May 2013 by Forest Laboratories
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01709214
First received: October 16, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 600
Study Start Date: November 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709214

Contacts
Contact: Sandra Beaird, PharmD 1-800-678-1605 ext 66297 FRXClinTrials@frx.com

  Show 93 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: May 6, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Oxycodone
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
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 23, 2013