Efficacy and Safety Study Evaluating ADL5859 and ADL5747 in Participants With Pain Due to Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00979953
First received: September 17, 2009
Last updated: April 21, 2015
Last verified: April 2015
  Purpose

The purpose of this study is to determine the efficacy of ADL5859 versus placebo and ADL5747 versus placebo in relieving pain in participants with osteoarthritis of the knee.


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: ADL5859
Drug: ADL5747
Drug: Oxycodone CR
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of ADL5859 and ADL5747 in Subjects With Moderate to Severe Pain Due to Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • Change From Baseline in the Average Pain Score (NPRS) for Week 2 [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
    The mean of the daily average scores were calculated from the NPRS pain assessment for the previous 24 hours obtained once a day for at least 4 days from Day -6 through Day 1 (Baseline assessment) and everyday from Day 2 through Day 15 (Treatment Phase assessment). The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain.


Enrollment: 408
Study Start Date: October 2009
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADL5859
One 50-milligrams (mg) ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally twice daily (BID) for 14 days
Drug: ADL5859 Drug: Placebo
Experimental: ADL5747
One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
Drug: ADL5747 Drug: Placebo
Active Comparator: Oxycodone CR

One 10-mg Oxycodone controlled release (CR) capsule and 3 placebo capsules administered orally BID Days 1 through 4

One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14

Drug: Oxycodone CR
Other Name: OxyContin
Drug: Placebo
Placebo Comparator: Placebo
Four placebo capsules administered orally BID for 14 days
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • a man or woman between 18 and 75 years of age, inclusive
  • for women of childbearing potential, be using an insertable, injectable, transdermal, or combination oral contraceptive deemed highly effective by the United States Food and Drug Administration from the first dose of study medication through the end of the study and have negative findings on pregnancy tests performed at screening and randomization (women who are surgically sterile [for example, hysterectomy, tubal ligation] or postmenopausal [if ≥55 years old, no menses for at least 2 years; if <55 years old, follicle-stimulating hormone concentrations within the postmenopausal range of >40 milli-international units per milliliter (mIU/mL) and 17 β-estradiol levels of <37 picograms per milliliter (pg/mL)] are also eligible to participate)
  • for male participants, be surgically sterile or agree to use an appropriate method of contraception (that is, use a barrier method in conjunction with spermicide or have a sexual partner who is surgically sterile, postmenopausal, or using an insertable, injectable, transdermal, or combination oral contraceptive deemed highly effective by the United States Food and Drug Administration) from the first dose of study medication through the end of the study
  • have a body weight between 45 and 150 kilograms (kg), inclusive
  • have had pain in the index knee for at least the past 6 months
  • meet the following criteria for osteoarthritis of the knee established by the American College of Rheumatology (radiographs must have been taken within the last year; if none is available, a radiograph must be taken and the diagnostic criteria must be confirmed before the participant is enrolled in the study): have index knee pain plus at least 1 moderate or definite osteophyte on radiographs. Must also have at least 1 of the following: be more than 50 years old, have morning stiffness for less than 30 minutes, or have crepitus on active motion
  • have an average weekly pain score of at least 4.00 on the numeric pain rating scale (NPRS) for the index knee during the baseline week before randomization (to be eligible for randomization, participants must report their NPRS score via the interactive voice-response system (IVRS) for at least 4 of the 7 days immediately before randomization, with the first score being recorded on Day -6)
  • if receiving nonselective or selective cyclooxygenase (COX) inhibitors, have a stable daily dose regimen for at least 4 weeks before screening; if receiving nonselective or selective COX inhibitors on an as needed basis, have discontinued use by Day -14; if receiving angiotensin-converting enzyme (ACE) inhibitors, have a stable dose regimen for at least 4 weeks before screening

Key Exclusion Criteria:

  • have undergone arthroscopy on the index knee within 6 months before study entry
  • have other severe pain that, in the opinion of the investigator, may impair the assessment of the pain due to osteoarthritis
  • have a history of hypersensitivity or intolerance to opioids (including tramadol and tapentadol)
  • have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant renal, hepatic, hematologic, cardiovascular, metabolic, gastrointestinal, neurologic, psychiatric, or another condition that would preclude participation in the study or affect the outcome of the study
  • have taken oral or intramuscular corticosteroids within 30 days before study entry (inhaled or topical corticosteroids are permitted)
  • have received intra-articular injections of corticosteroids into the index joint within 12 weeks before screening
  • have received intra-articular injections of hyaluronic acid into the index joint within 24 weeks before screening
  • currently taking medications other than nonsteroidal anti-inflammatory drugs prescribed for chronic pain (such as duloxetine or pregabalin)
  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: NCT00979953

Locations
United States, Florida
Covance CRU, Inc
Daytona Beach, Florida, United States, 32117
United States, Georgia
Atlanta Knee and Shoulder Clinic, PC
Stockbridge, Georgia, United States, 30281
United States, Illinois
University Rheumatoloty Center for Clinical Research
Chicago, Illinois, United States, 60612
Clinical Investigation Specialists, Inc
Gurnee, Illinois, United States, 60031
United States, North Carolina
Cresent Medical Research
Salisbury, North Carolina, United States, 28144
New Hanover Medical Research
Wilmington, North Carolina, United States, 28401
United States, Ohio
Columbus Clinical Research
Columbus, Ohio, United States, 43213
PSB Research
Mt Gilead, Ohio, United States, 43338
Bone Joint & Spine Surgeons, Inc
Toledo, Ohio, United States, 43623
United States, South Carolina
Radient Research
Anderson, South Carolina, United States, 29621
United States, Texas
Quality Research
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Cubist Pharmaceuticals
Pfizer
Investigators
Study Director: Bruce Berger, MD Cubist Pharmaceuticals
  More Information

No publications provided

Responsible Party: Cubist Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00979953     History of Changes
Other Study ID Numbers: 44CL240
Study First Received: September 17, 2009
Results First Received: April 21, 2015
Last Updated: April 21, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
delta opioid receptor agonist
osteoarthritis
pain

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

ClinicalTrials.gov processed this record on May 20, 2015