Phase 2 Efficacy Trial of OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With OA of the Knee

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis of the Knee

In brief

The purpose of this trial is to investigate the efficacy and safety of OLT1177 Gel in subjects with moderate to severe pain associated with osteoarthritis of the knee following cessation of pain therapy.

Key facts

Study ID

NCT01768975

Run by

Olatec Therapeutics, Inc.

People needed

79

Starts

2013-01-01

Expected to finish

2013-08-01

Last updated by the study team

2014-10-06

Who can join

Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 35 to 80
• Subjects of childbearing potential and their partners must use effective contraception
• OA based on the ACR criteria
• OA of the knee ≥ 6 months prior to Screening
• OA knee pain which required NSAID or other therapy for ≥ 15 days
• Pain on Movement in the contralateral knee be ≤ 20 mm
• Radiographic evidence of OA by Kellgren-Lawrence score of 2 or 3 taken 6 months prior to Screening
• Moderate to severe OA pain defined as POM score between 50 mm and 90 mm
• Baseline WOMAC pain subscale score ≥ 9
• No change in physical activity and/or therapy for the past 3 months
• Provide written informed consent and comply with the trial

You may not qualify if…

• Use of Rescue Medication or any other pain medication 48 hours prior to Baseline visit
• Inflammatory skin condition over the target knee
• Extreme pain in the target knee characterized by POM score of > 90 mm
• Mild pain in the target knee, characterized by POM score of < 50 mm
• > 30 mm POM score variability in Days -2 to -1 from Baseline visit
• Baseline POM score of > 20 mm for the contralateral knee or any other significant joint or general pain at Baseline visit
• Excessive effusion in the target knee
• Heat and/or redness in comparison to the contralateral knee
• Knock-kneed or bow-legged defined by valgus or varus deformity of ≥ 15 degrees
• Acute or chronic injury other than OA
• Radiographic evidence of OA by Kellgren-Lawrence score of 0, 1 or 4
• Open surgery of the target knee within the last year
• Arthroscopic surgery of the target knee within the last 6 months
• Surgery of the target knee requiring insertion of a medical device or surgical hardware
• Use of prohibited concomitant medications/therapies during the 7-day washout period or planned use during the 14-day treatment period including:
• Prescription medications to treat pain, OTC and natural supplements
• Muscle relaxants unless on a stable dose ≥ 30 days prior to Screening
• Nutraceuticals unless on a stable dose ≥ 3 months prior to Screening
• Sedative hypnotics unless on a stable dose ≥ 30 days prior to Screening
• Devices or therapeutic treatments for knee pain or ambulation
• Systemic corticosteroids
• Other Investigational Drugs
• Chemotherapeutic drugs
• Immunotherapy
• Topical products applied to the target knee

Where it is running

• Avail Clinical Research — DeLand, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Wake Research Associates — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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