Phase 2
N=389
A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee
Osteoarthritis of the Knee
Bottom Line
View on ClinicalTrials.gov: NCT02068599 ↗Enrolled (actual)
389
Serious AEs
0.5%
Results posted
Oct 2018
Primary outcome: Primary: 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) — -20.56; -23.08; -24.82 units on a scale — p=0.1213
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TV-45070 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
-20.56; -23.08; -24.82 | 0.1213 |
| SECONDARY 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 |
-99.67; -108.52; -117.53 | 0.1795 |
| SECONDARY 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) |
-19.84; -21.39; -23.45 | 0.1963 |
| SECONDARY 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 |
-372.88; -446.79; -396.39 | 0.6420 |
| SECONDARY 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 |
-45.85; -52.49; -49.01 | 0.6184 |
| SECONDARY 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 |
23.3; 33.6; 31.5; 70.5; 62.5; 60.8 | 0.1011 |
| SECONDARY 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 |
-39.22; -40.65; -43.16 | 0.4316 |
| SECONDARY 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) |
2.87; 2.90; 2.86; 2.81; 2.66; 2.60 | 0.9208 |
| SECONDARY Change From Baseline in the Patient Global Assessment (PGA) Scores at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM) |
4.87; 3.51; 2.10; 5.44; 6.35; 4.62 | 0.2906 |
| SECONDARY Percentage of Participants Who Are Responders Per Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 4 |
47.3; 59.4; 51.5; 46.5; 36.7; 40.8 | 0.5358 |
| SECONDARY Participants With Treatment-Emergent Adverse Events |
43; 37; 47; 12; 10; 20 | — |
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
Data sourced from ClinicalTrials.gov (NCT02068599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.