Study of OLT1177 Gel to Treat Moderate to Severe OA Knee Pain

NCT02104050 | Completed Phase 2

• 1 other identifier: OLT1177-03
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 13

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.

Conditions

Osteoarthritis; Pain

Outcome Measures

Primary Outcomes (1)

• Pain on Movement

  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?'

  Baseline to Week 6

Secondary Outcomes (10)

• Current Knee Pain

  Baseline (pre-dose) to Baseline (50-min post-dose)

• 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

• Current Knee Pain

  Baseline to Hours 2-6

Other Outcomes (14)

• Physical Examination: Number of subjects with clinically significant changes in Physical Examination in major body systems (HEENT, Neck, Cardiovascular, Abdominal, Respiratory, Musculoskeletal, Extremities Skin or Other)

  Baseline through Week 8

• Vital Signs: Change from Baseline in Heart Rate (beats per minute)

  Baseline through Week 8

• Vital Signs: Change from Baseline in Supine Diastolic Blood Pressure [mmHg]

  Baseline through Week 8

Study Arms (2)

Placebo Gel

PLACEBO COMPARATOR

6 mL of Placebo Gel administered TID for 6 weeks

Drug: Placebo Gel

OLT1177 Gel

EXPERIMENTAL

6 mL of OLT1177 Gel (5%) administered TID for 6 weeks

Drug: OLT1177 Gel

Interventions

Placebo Gel DRUG

6 mL of Placebo Gel administered TID for 6 weeks

Placebo Gel

OLT1177 Gel DRUG

6 mL of OLT1177 Gel (5%) administered TID for 6 weeks

OLT1177 Gel

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Knee Pain
• 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)
• Meets pain assessment entry criteria as defined by Sponsor's pain eligibility algorithm and calculated by the study Interactive Web Response System
• No clinically significant change in physical activity and/or therapy for the past 3 months
• Able to provide written informed consent prior to initiation of any clinical trial-related procedures; and willing and able, in the opinion of the Investigator, to comply with all requirements of the clinical trial for the duration of the trial (such requirements include, but are not limited to: attending all study visits, refraining from elective surgery or extensive travel during participation)

You may not qualify if:

• General
• 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
• Does not meet pain assessment entry criteria as defined by Sponsor's pain eligibility algorithm and calculated by the study Interactive Web Response System
• Clinically significant joint (other than the knee) or general pain at Baseline, at the discretion of the Investigator
• Musculoskeletal Related
• Clinically significant, excessive effusion heat and/or redness in the target knee as determined by the Investigator

Sponsors & Collaborators

• Olatec Therapeutics LLC: lead

Study Sites (13)

Achieve Clinical Research, LLC

Birmingham, Alabama, 35216, United States

Location

Clinical Research Consulting, LLC

Milford, Connecticut, 06460, United States

Location

Avail Clinical Research

DeLand, Florida, 32720, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Sunrise Medical Research, Inc.

Lauderdale Lakes, Florida, 33319, United States

Location

International Clinical Research - US, LLC

Sanford, Florida, 32771, United States

Location

Miami Research Associates, LLC

South Miami, Florida, 33143, United States

Location

Best Clinical Trial, LLC

New Orleans, Louisiana, 70115, United States

Location

Healthcare Research Network, Inc.

Hazelwood, Missouri, 63042, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Coastal Carolina Research Center, Inc

Mt. Pleasant, South Carolina, 29464, United States

Location

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, 22911, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William Cunningham, MD, FAAD

  Cu-Tech, LLC

  STUDY CHAIR

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: March 28, 2014
• First Posted: April 4, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 6, 2017

Record last verified: 2017-04

Locations

US (13)