Osteoarthritis Clinical Trial
Official title:
A Randomized, Double-blind, Multicenter, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR® Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain: A 52-Week Extension Phase
| Verified date | September 2012 |
| Source | Purdue Pharma LP |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.
| Status | Terminated |
| Enrollment | 196 |
| Est. completion date | August 2005 |
| Est. primary completion date | August 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Inclusion Criteria: - Subjects who completed all visits of the double-blind phase on study drug and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase. Exclusion Criteria: - Subjects who prematurely discontinue study drug in the double-blind phase due to adverse event, subject's choice, administrative reason or lost to follow-up are NOT eligible to enter the extension phase - Subjects with electrocardiograms (ECGs) that show any QT data corrected for heart rate using Fridericia formula (QTcF) interval = 500 millisecond (msec) will be discontinued from the extension phase. - Subjects requiring long-acting opioid analgesics (once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug) or transdermal fentanyl during the extension phase should be discontinued from the study. Refer to core study for additional inclusion/exclusion information. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Alabama Neurology and Pain Medicine | Alabaster | Alabama |
| United States | Research Facility | Altoona | Pennsylvania |
| United States | Allergy ARTS | Amarillo | Texas |
| United States | Research Facility | Baltimore | Maryland |
| United States | Crystal Lake Health Center | Benzonia | Michigan |
| United States | Research Facility | Birmingham | Alabama |
| United States | The Birmingham Pain Center | Birmingham | Alabama |
| United States | University of Alabama Hospital | Birmingham | Alabama |
| United States | Research Facility | Boise | Idaho |
| United States | Research Facility | Bridgeport | Connecticut |
| United States | Research Facility | Brockton | Massachusetts |
| United States | Research Facility | Buena Park | California |
| United States | The Arthritis Clinic and Carolina Bone and Joint | Charlotte | North Carolina |
| United States | Research Facility | Chicago | Illinois |
| United States | Research Facility | Chula Vista | California |
| United States | Research Facility | Cincinnati | Ohio |
| United States | Patuxent Medical Group | Columbia | Maryland |
| United States | Research Facility | Columbus | Ohio |
| United States | Research Facility | Conroe | Texas |
| United States | Research Facility | Coral Gables | Florida |
| United States | Family Practice Associates | Corpus Christi | Texas |
| United States | New England Center for Clinical Research | Cranston | Rhode Island |
| United States | Research Facility | Dallas | Texas |
| United States | Research Facility | Dallas | Texas |
| United States | Research Facility | Daytona Beach | Florida |
| United States | Research Facility | Duncansville | Pennsylvania |
| United States | Triangle Orthopaedic Associates | Durham | North Carolina |
| United States | Research Facility | Eugene | Oregon |
| United States | HealthSouth Metro West Hospital | Fairfield | Alabama |
| United States | Research Facility | Fresno | California |
| United States | Research Facility | Greensboro | North Carolina |
| United States | Radiant Research | Greer | South Carolina |
| United States | Research Facility | Hagerstown | Maryland |
| United States | Research Facility | Hialeah | Florida |
| United States | Research Facility | Hickory | North Carolina |
| United States | Cornerstone Research Care | High Point | North Carolina |
| United States | Hot Springs Pain Clinic | Hot Springs | Arkansas |
| United States | Research Facility | Houston | Texas |
| United States | KC Pain Centers East | Independence | Missouri |
| United States | The Clinical Trial Center | Jenkintown | Pennsylvania |
| United States | Research Facility | Jupiter | Florida |
| United States | Rheumatology PC | Kalamazoo | Michigan |
| United States | Research Facility | Lansing | Michigan |
| United States | Research Facility | Largo | Florida |
| United States | Research Facility | Las Vegas | Nevada |
| United States | Research Facility | Las Vegas | Nevada |
| United States | Research Facility | Los Gatos | California |
| United States | Louisville Endocrinology PSC | Louisville | Kentucky |
| United States | Research Facility | Madisonville | Kentucky |
| United States | Research Facility | Marietta | Georgia |
| United States | Research Facility | Mechanicsburg | Pennsylvania |
| United States | Idaho Arthritis Osteoporosis | Meridian | Idaho |
| United States | Research Facility | Miami | Florida |
| United States | Research Facility | Milwaukee | Wisconsin |
| United States | Research Facility | New Berlin | Wisconsin |
| United States | Dolby Providers | New Orleans | Louisiana |
| United States | Research Facility | New Orleans | Louisiana |
| United States | Research Facility | New Orleans | Louisiana |
| United States | Research Facility | New York | New York |
| United States | Research Facility | North Miami Beach | Florida |
| United States | Research Facility | Ocala | Florida |
| United States | Research Facility | Oklahoma City | Oklahoma |
| United States | Research Facility | Ormond Beach | Florida |
| United States | Research Facility | Palm Harbor | Florida |
| United States | Research Facility | Pembroke Pines | Florida |
| United States | Arizona Research Center | Phoenix | Arizona |
| United States | Research Facility | Phoenix | Arizona |
| United States | Research Facility | Phoenix | Arizona |
| United States | Radiant Research | Pinellas Park | Florida |
| United States | Research Facility | Plantation | Florida |
| United States | Research Facility | Port Orange | Florida |
| United States | Research Facility | Pueblo | Colorado |
| United States | KRK Medical Research | Richardson | Texas |
| United States | Research Facility | Roseville | California |
| United States | Research Facility | San Antonio | Texas |
| United States | Research Facility | San Antonio | Texas |
| United States | NTOUCH Research Corporation | San Diego | California |
| United States | Research Facility | San Diego | California |
| United States | Research Facility | Spokane | Washington |
| United States | Research Facility | Springfield | Illinois |
| United States | HealthCare Research LLC | St. Louis | Missouri |
| United States | Research Facility | St. Louis | Missouri |
| United States | Research Facility | Syracuse | New York |
| United States | Research Facility | Tampa | Florida |
| United States | Research Facility | Torrence | California |
| United States | Research Facility | Tucson | Arizona |
| United States | Research Facility | Upland | California |
| United States | Integrated Clinical Trials | West Des Moines | Iowa |
| United States | Research Facility | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Purdue Pharma LP |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements. | 52 weeks | Yes |
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