A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee
NCT ID: NCT02068599
Last Updated: 2021-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
389 participants
INTERVENTIONAL
2014-04-14
2015-05-04
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TV-45070 4%
TV-45070 ointment in a 4% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
TV-45070
TV-45070 ointment administered twice a day (morning and evening) to target knee. Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area. The ointment was gently massaged into the skin.
TV-45070 8%
TV-45070 ointment in a 8% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
TV-45070
TV-45070 ointment administered twice a day (morning and evening) to target knee. Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area. The ointment was gently massaged into the skin.
Placebo
Placebo ointment applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
Placebo
Placebo ointment matching active intervention administered twice a day (morning and evening) to target knee. Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area. The ointment was gently massaged into the skin.
Interventions
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TV-45070
TV-45070 ointment administered twice a day (morning and evening) to target knee. Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area. The ointment was gently massaged into the skin.
Placebo
Placebo ointment matching active intervention administered twice a day (morning and evening) to target knee. Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area. The ointment was gently massaged into the skin.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics at the time of the screening visit,
* Patient has visual analog scale (VAS) pain scores with acceptable ranges as determined by the investigator during screening
* Except for OA, patient is judged by the investigator to be medically healthy and able to participate in the study.
* Other criteria apply, please contact the investigator for additional information
Exclusion Criteria
* Patient has symptomatic chondrocalcinosis
* Patient has a history of fibromyalgia.
* Patient has any painful or disabling conditions that in the opinion of the investigator may confound assessment of pain scoring.
* Patient has uncontrolled cardiac, renal, hepatic or other systemic disorders that in the opinion of the investigator may jeopardize the patient.
* Patient has significant edema or skin disorder (including sores, rashes, or ulcers) at the target knee and surrounding area.
* Patient has a history of total or partial knee replacement in either leg.
* Patient had a major reconstructive knee surgery or arthroscopy of the target knee within 6 months before the screening visit.
* Patient is unable or unwilling to discontinue opioid and/or other prescription analgesics for control of OA pain.
* Patient is intolerant to study drug, its excipients, and/or acetaminophen.
* Patient uses any over the counter oral medications such as glucosamine or chondroitin sulfate products, unless the patient has been receiving the medication for ≥3 months at the time of the screening visit and maintains the medication as stable therapy for the duration of the study.
* Other criteria apply, please contact the investigator for additional information
40 Years
85 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sr. Director, GCO, Theraputic Area Head
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Investigational Site 12217
Anaheim, California, United States
Teva Investigational Site 12244
Anaheim, California, United States
Teva Investigational Site 12252
Cerritos, California, United States
Teva Investigational Site 13009
Cerritos, California, United States
Teva Investigational Site 12233
El Cajon, California, United States
Teva Investigational Site 12240
Lomita, California, United States
Teva Investigational Site 12251
Sacramento, California, United States
Teva Investigational Site 12234
Spring Valley, California, United States
Teva Investigational Site 12256
Clearwater, Florida, United States
Teva Investigational Site 12241
DeLand, Florida, United States
Teva Investigational Site 12246
Eustis, Florida, United States
Teva Investigational Site 12231
Fort Myers, Florida, United States
Teva Investigational Site 12216
Hialeah, Florida, United States
Teva Investigational Site 12230
Jacksonville, Florida, United States
Teva Investigational Site 12220
Miami, Florida, United States
Teva Investigational Site 12221
Oldsmar, Florida, United States
Teva Investigational Site 12226
Orlando, Florida, United States
Teva Investigational Site 12237
Orlando, Florida, United States
Teva Investigational Site 12255
Ormond Beach, Florida, United States
Teva Investigational Site 12225
Plantation, Florida, United States
Teva Investigational Site 12229
Sanford, Florida, United States
Teva Investigational Site 12235
Tampa, Florida, United States
Teva Investigational Site 12253
Atlanta, Georgia, United States
Teva Investigational Site 12250
Marietta, Georgia, United States
Teva Investigational Site 12243
Evansville, Indiana, United States
Teva Investigational Site 12238
Overland Park, Kansas, United States
Teva Investigational Site 12218
New Orleans, Louisiana, United States
Teva Investigational Site 12245
Watertown, Massachusetts, United States
Teva Investigational Site 12228
Bingham Farms, Michigan, United States
Teva Investigational Site 12242
Hazelwood, Missouri, United States
Teva Investigational Site 12249
St Louis, Missouri, United States
Teva Investigational Site 12223
Omaha, Nebraska, United States
Teva Investigational Site 12219
New York, New York, United States
Teva Investigational Site 12239
Charlotte, North Carolina, United States
Teva Investigational Site 12248
Raleigh, North Carolina, United States
Teva Investigational Site 12247
Winston-Salem, North Carolina, United States
Teva Investigational Site 12254
Winston-Salem, North Carolina, United States
Teva Investigational Site 12224
Cincinnati, Ohio, United States
Teva Investigational Site 12236
Memphis, Tennessee, United States
Teva Investigational Site 12232
Dallas, Texas, United States
Teva Investigational Site 12227
Plano, Texas, United States
Teva Investigational Site 12222
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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TV-45070-CNS-20005
Identifier Type: -
Identifier Source: org_study_id