NCT02104050
Completed
Phase 2
A Phase 2b Randomized, Double-Blind, Vehicle-Controlled, Repeat-Dose, Multi- Center, Efficacy and Safety Clinical Trial of Topically Applied OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With Osteoarthritis of the Knee Following Cessation of Pain Therapy
Overview
- Phase
- Phase 2
- Intervention
- Placebo Gel
- Conditions
- Osteoarthritis
- Sponsor
- Olatec Therapeutics LLC
- Enrollment
- 202
- Locations
- 13
- Primary Endpoint
- Pain on Movement
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The objectives of this trial are to investigate the efficacy and safety of six weeks of treatment with OLT1177 Gel in subjects with moderate to severe pain associated with osteoarthritis of the knee following cessation of pain therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 45 to 80 years old, inclusive
- •Clinical diagnosis of osteoarthritis in one target knee based on the following American College of Rheumatology (ACR) criteria:
- •At least 1 of 3:
- •Age \> 50 years
- •Morning stiffness lasting \< 30 minutes
- •Crepitus on motion
- •Osteophytes on radiograph
- •Symptoms associated with osteoarthritis of the knee (including pain) for ≥ 6 months prior to Screening
- •Knee pain associated with osteoarthritis, which required NSAID or other therapy for ≥ 15 days during the preceding month
- •Radiographic evidence of osteoarthritis by Kellgren-Lawrence classification with a rating of Grade 2 or 3 in the target knee (does not include borderline Grade 2), as confirmed by the Sponsor's designated rheumatologist through radiographic review of x-ray(s) taken no more than 1 year prior to the Screening visit. (Sharpening of the tibial spine is not considered to be an osteophyte) (See Appendix 4 for additional details)
Exclusion Criteria
- •Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential may not be entered into the study if:
- •They are or intend to become pregnant (including use of fertility drugs) during the study
- •They are nursing
- •They are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. (Acceptable, highly effective forms of contraception are defined as: oral contraception, intrauterine device, systemic \[injectable or patch\] contraception, double barrier methods, naturally or surgically sterile, strict abstinence or partner has been sterilized. If hormonal-based birth control is being used, subject or subject's sexual partner(s) must be on a stable-dose for ≥ 3 months prior to the Baseline visit and maintained at the same dosing level throughout the 9-week clinical trial.)
- •Body Mass Index (BMI) over 40
- •A history of osteoarthritis symptoms that are completely non-responsive to non-steroidal anti-inflammatory drugs (NSAIDs) at the discretion of the Investigator
- •Planned change (increase or decrease) in subject's level of physical activity (e.g., aerobic or anaerobic exercise) during the 6-week Treatment Period following randomization
- •Enrollment in any trial and/or use of any Investigational Drug or device within the immediate 30-day period prior to the Baseline visit
- •Enrollment in any study previously sponsored by Olatec Industries LLC, specifically Study OLT1177-01 or OLT1177-02
- •Pain Related
Arms & Interventions
Placebo Gel
6 mL of Placebo Gel administered TID for 6 weeks
Intervention: Placebo Gel
OLT1177 Gel
6 mL of OLT1177 Gel (5%) administered TID for 6 weeks
Intervention: OLT1177 Gel
Outcomes
Primary Outcomes
Pain on Movement
Time Frame: Baseline to Week 6
Subjects will record their level of Pain on Movement in the target knee on a 100-mm VAS scale (with anchors 0=no pain; 100=extreme pain) in response to the question, 'How do you estimate the average amount of your study knee pain while moving during your daily activities within the last 24 hours?'
Secondary Outcomes
- Current Knee Pain(Baseline to Hours 2-6)
- Use of Rescue Medication(Baseline through Week 6)
- Short Form 12v2 Health Survey(Baseline to Weeks 2, 4 and 6)
- WOMAC Stiffness Subscale(Baseline to Weeks 2, 4 and 6)
- Pain on Movement (VAS, in-clinic)(Baseline to Weeks 2, 4 and 6)
- Pain on Movement (11-point NRS, diary)(Baseline through Week 6)
- WOMAC Pain Subscale(Baseline to Weeks 2, 4 and 6)
- WOMAC Physical Function Subscale(Baseline to Weeks 2, 4 and 6)
- Global Rating of Disease(Baseline to Weeks 2, 4 and 6)
Study Sites (13)
Loading locations...
Similar Trials
Unknown
Phase 2
A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.Hepatitis BNCT00044135Triangle Pharmaceuticals30
Completed
Phase 2
A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.Cutaneous WartsNCT02333643Maruho Co., Ltd.81
Completed
Phase 2
Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 InfectionHepatitis C VirusNCT02349048Janssen Research & Development, LLC68
Completed
Phase 2
A Study of ARRY-502 in Patients With Persistent AsthmaAsthmaNCT01561690Pfizer184
Completed
Phase 2
B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic DermatitisAtopic DermatitisPruritusNCT04490109AOBiome LLC547