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

NCT01768975 | Completed Phase 2

• 1 other identifier: OLT1177-02
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Osteoarthritis of the Knee

Keywords

Knee; Osteoarthritis; OA; Knee pain; Moderate pain; Severe pain; Inflammation; Safety; Efficacy; Randomized; Topical; Gel; Olatec; OLT1177; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Therapeutic; Analgesic

Outcome Measures

Primary Outcomes (1)

• Change in WOMAC knee pain subscale (scale 0 - 20)

  The mean group change for OLT1177 Gel and vehicle control from Baseline (Day 0) to Day 14 in WOMAC knee pain subscale (Scale 0-20), which is determined by the subjects responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4)

  14 days

Secondary Outcomes (17)

• Change in Current Knee Pain (100-mm VAS)

  50 minutes post dose (± 10 minutes)

• Mean group rating of Relative Knee Pain (5-point scale)

  50 minutes post dose (± 10 minutes)

• Change in WOMAC knee pain subscale

  7 days

• Change in Pain on Movement (100-mm VAS)

  7 days

• Change in Pain on Movement (100-mm VAS)

  14 days

Study Arms (2)

OLT1177 Gel

EXPERIMENTAL

4 mL per dose, applied 3 times per day on Days 1 - 13 with only one dose administered on Day 14, assuming TID on Day 1

Drug: OLT1177 Gel

Placebo gel

PLACEBO COMPARATOR

Identical dose and dosing regimen as the Investigational Drug (OLT1177 Gel)

Other: Placebo gel

Interventions

OLT1177 Gel DRUG

4 mL per dose, applied 3 times per day on Days 1 - 13 with only one dose administered on Day 14, assuming TID on Day 1

Also known as: OLT1177

OLT1177 Gel

Placebo gel OTHER

Identical dose and dosing regimen as the Investigational Drug (OLT1177 Gel)

Placebo gel

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• Olatec Therapeutics LLC: lead

Study Sites (3)

Avail Clinical Research

DeLand, Florida, 32720, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain; Inflammation; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis

Interventions

dapansutrile

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jaime A. Pachon, MD

  Miami Research Associates

  PRINCIPAL INVESTIGATOR

• Bruce G. Rankin, D.O., C.P.I

  Avail Clinical Research

  PRINCIPAL INVESTIGATOR

• Treva W. Tyson, MD

  Wake Research Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 16, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 6, 2014

Record last verified: 2014-09

Locations

US (3)