Clinical trial NCT02068599: A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (4% and 8% w/w Ointment) in Patients With Primary Osteoarthritis Affecting a Single Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis
OA
Arthritis pain
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-21
Enrollment: 389
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of the study is to evaluate the change from baseline after 4 weeks of topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief of symptoms of primary OA affecting a single knee


Eligibility criteria: Inclusion Criteria:

* Patient is between 40 and 85 years of age, Patient has primary OA in a single knee (target knee) confirmed by American College of Rheumatology 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 secondary or inflammatory arthritis of the knee such as psoriasis, rheumatoid arthritis (RA), gout, other primary bone disease, or acute trauma.
* 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

Primary outcomes:
measure: Change From Baseline to Last 5 Days of Treatment in the Average Evening Pain Intensity In the Target Knee When Walking on a Flat Surface Using a Mixed Model for Repeated Measures (MMRM)
timeFrame: Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
Secondary outcomes:
measure: Change From Baseline to Last 5 Days of Treatment in the Average Daily WOMAC Pain Subscale Score In the Target Knee Using a Mixed Model for Repeated Measures
timeFrame: Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
measure: Change From Baseline to Last 5 Days of Treatment in the Average Morning Pain Intensity In the Target Knee When Walking on a Flat Surface Using a Mixed Model for Repeated Measures (MMRM)
timeFrame: Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
measure: Change From Baseline (Randomization Visit) to the Week 4 Visit in the WOMAC Physical Function Subscale Score for the Target Knee Using a Mixed Model for Repeated Measures
timeFrame: Baseline (day 1, predose), Treatment: Week 4 (day 29)
measure: Change From Baseline (Randomization Visit) to the Week 4 Visit in the WOMAC Stiffness Subscale Score for the Target Knee Using a Mixed Model for Repeated Measures
timeFrame: Baseline (day 1, predose), Treatment: Week 4 (day 29)
measure: Percentage of Participants With a >=30% and a >=50% Response in Average Evening Pain Intensity of WOMAC Question 1 in the Target Knee During the Last 5 Days of Treatment Compared With Baseline
timeFrame: Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
measure: Change From Baseline (Randomization Visit) to the Week 4 Visit in the Pain Quality Assessment Scale - Revised (PQAS-R) for the Target Knee Using a Mixed Model for Repeated Measures
timeFrame: Baseline (day 1, predose), Treatment: Week 4 (day 29)
measure: Participants' Global Assess of Treatment as Measured by the Patient Global Impression of Change (PGIC) at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM)
timeFrame: Weeks 2 (day 15), 4 (day 29)
measure: Change From Baseline in the Patient Global Assessment (PGA) Scores at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM)
timeFrame: Baseline (day 1, predose), Week 2 (day 15) and Week 4 (day 29)
measure: Percentage of Participants Who Are Responders Per Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 4
timeFrame: Week 4 (day 29)
measure: Participants With Treatment-Emergent Adverse Events
timeFrame: day 1 up to day 57
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Teva Investigational Site 12217
state: California
city: Anaheim
country: United States
facility: Teva Investigational Site 12244
state: California
city: Cerritos
country: United States
facility: Teva Investigational Site 12252
state: California
city: Cerritos
country: United States
facility: Teva Investigational Site 13009
state: California
city: El Cajon
country: United States
facility: Teva Investigational Site 12233
state: California
city: Lomita
country: United States
facility: Teva Investigational Site 12240
state: California
city: Sacramento
country: United States
facility: Teva Investigational Site 12251
state: California
city: Spring Valley
country: United States
facility: Teva Investigational Site 12234
state: California
city: Clearwater
country: United States
facility: Teva Investigational Site 12256
state: Florida
city: DeLand
country: United States
facility: Teva Investigational Site 12241
state: Florida
city: Eustis
country: United States
facility: Teva Investigational Site 12246
state: Florida
city: Fort Myers
country: United States
facility: Teva Investigational Site 12231
state: Florida
city: Hialeah
country: United States
facility: Teva Investigational Site 12216
state: Florida
city: Jacksonville
country: United States
facility: Teva Investigational Site 12230
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 12220
state: Florida
city: Oldsmar
country: United States
facility: Teva Investigational Site 12221
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 12226
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 12237
state: Florida
city: Ormond Beach
country: United States
facility: Teva Investigational Site 12255
state: Florida
city: Plantation
country: United States
facility: Teva Investigational Site 12225
state: Florida
city: Sanford
country: United States
facility: Teva Investigational Site 12229
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 12235
state: Florida
city: Atlanta
country: United States
facility: Teva Investigational Site 12253
state: Georgia
city: Marietta
country: United States
facility: Teva Investigational Site 12250
state: Georgia
city: Evansville
country: United States
facility: Teva Investigational Site 12243
state: Indiana
city: Overland Park
country: United States
facility: Teva Investigational Site 12238
state: Kansas
city: New Orleans
country: United States
facility: Teva Investigational Site 12218
state: Louisiana
city: Watertown
country: United States
facility: Teva Investigational Site 12245
state: Massachusetts
city: Bingham Farms
country: United States
facility: Teva Investigational Site 12228
state: Michigan
city: Hazelwood
country: United States
facility: Teva Investigational Site 12242
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 12249
state: Missouri
city: Omaha
country: United States
facility: Teva Investigational Site 12223
state: Nebraska
city: New York
country: United States
facility: Teva Investigational Site 12219
state: New York
city: Charlotte
country: United States
facility: Teva Investigational Site 12239
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 12248
state: North Carolina
city: Winston-Salem
country: United States
facility: Teva Investigational Site 12247
state: North Carolina
city: Winston-Salem
country: United States
facility: Teva Investigational Site 12254
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Investigational Site 12224
state: Ohio
city: Memphis
country: United States
facility: Teva Investigational Site 12236
state: Tennessee
city: Dallas
country: United States
facility: Teva Investigational Site 12232
state: Texas
city: Plano
country: United States
facility: Teva Investigational Site 12227
state: Texas
city: Charlottesville
country: United States
facility: Teva Investigational Site 12222
state: Virginia
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Sr. Director, GCO, Theraputic Area Head
role: STUDY_DIRECTOR
References: