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

Olatec Therapeutics

Status and phase

Completed

Phase 2

Conditions

Osteoarthritis

Pain

Treatments

Drug: OLT1177 Gel

Drug: Placebo Gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT02104050

OLT1177-03

Details and patient eligibility

About

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.

Enrollment

202 patients

Sex

All

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

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:
1. Knee Pain
2. At least 1 of 3:
  - Age > 50 years
  - Morning stiffness lasting < 30 minutes
  - Crepitus on motion
3. 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)

Exclusion criteria

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:
1. They are or intend to become pregnant (including use of fertility drugs) during the study
2. They are nursing
3. 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
Knock-kneed or bow-legged, as defined by a valgus or varus deformity of ≥ 15 degrees
Radiographic evidence of osteoarthritis by Kellgren-Lawrence classification with a rating of Grade 0, 1 or 4 in the target knee, 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)
Documented history of clinically significant pain associated with osteoarthritis of the spine or hips, at the discretion of the Investigator
Significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia
Clinically significant medio-lateral and/or anterior-posterior instability, at the discretion of the Investigator
Open surgery of the target knee within the prior year or surgery to the contralateral knee or other weight-bearing joint within the prior year, if at the discretion of the Investigator it would interfere with the study. If subject had open surgery more than one-year prior, Sponsor's designated rheumatologist must confirm that such surgery did not have any negative impact or consequence to the target knee (e.g., deformity of angle to the bone, bone on bone, locking joints, etc.)
Arthroscopic surgery of the target knee within the prior six months
Any acute or chronic injury, other than osteoarthritis in the target knee, that will be treated during the trial with any medication not allowed during the Treatment Period
Prior surgery of the target knee requiring insertion of a medical device or surgical hardware (e.g., screws)
Any major trauma or injury (including sports injuries) to the target knee in the past 12 months
Documented history of inflammatory joint disease, including but not limited to: rheumatoid arthritis, gout, pseudogout, Paget's disease, psoriatic arthritis, ankylosing spondylitis, chronic inflammatory disease (e.g., colitis), fibromyalgia (diagnosed in accordance with ACR criteria, as applicable), articular fracture, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders (e.g., hypermobility) or collagen gene mutations
Any planned interventional and/or surgical procedure during the 6-week Treatment Period following randomization

Concomitant Conditions, Diseases, Medications/Therapies and Medical History Related

Any use of Rescue Medication within 24 hours prior to the Baseline visit or use of any other pain medication within 7 days prior to Baseline visit
Uncontrolled hypertension, defined as blood pressure ≥ 150/95 mmHg
A history of uncontrolled and untreated diabetes mellitus with an HbA1c level > 8; or blood sugar levels that are outside of the normal range and HbA1c level > 8 is subsequently confirmed
Any inflammatory skin condition over the target knee application area
Use of any prohibited concomitant medications/therapies during the 7-day Washout Period or planned use of any prohibited concomitant medications/therapies during the 6 week Treatment Period
Use of intraarticular or intramuscular steroids in the target knee within the previous 3 months or in any other joint within the previous 30 days
Use of intraarticular hyaluronate in the target knee within the previous 6 months or in any other joint within the previous 30 days
Current substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse (including alcoholism and/or addiction to pain medications) that is determined at the discretion of the Investigator as likely to interfere with trial assessments or recur during the trial
Use of any systemic (oral or parenteral) corticosteroids within the prior month
Uncontrolled psychiatric conditions (e.g., mania, depression, anxiety, substance dependence of any kind) that would impair the subject from safely participating in the trial, including completing any protocol requirements
Evidence of cognitive impairment including dementia that may interfere with subject's ability to complete daily pain diaries requiring recall of average pain level in the past 24 hours
Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological or neurological disease or prior surgery that may interfere with the subject successfully completing the trial, including completing any protocol requirements as determined by the Investigator
History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis C Virus (HCV)
Diagnosed with any form of cancer within the past 5 years, except for treated basal cell or squamous cell carcinoma of the skin
Any other medical conditions, diseases or prior surgeries that in the opinion of the Investigator would impair the subject from safely participating in the trial and/or completing any protocol requirements
Active infection within 3 days of the Baseline visit