Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a study of an over-the-counter, capsaicin-based (0.25%) topical analgesic for management of osteoarthritis knee pain meeting the US Food and Drug Administration's (FDAs) Tentative Final Monograph (TFM) guidance for "External Analgesic Drug Products For Over-the-Counter Human Use," published in the Federal Register on February 8, 1983 (final proposed 21 CFR 348). Subjects meeting the inclusion criteria and not meeting the exclusion criteria were randomized into one of four groups: once daily treatment with active product, once daily treatment with product vehicle (no capsaicin), twice daily treatment with active product, and twice daily treatment with product vehicle (no capsaicin), all for 7 consecutive days of treatment. The twice daily treatments were spaced approximately 12 hours apart. Osteoarthritis knee pain was assessed by the 100 mm visual analog scale. Osteoarthritis knee pain assessments were done each day for 28 days. Tolerability data were also collected.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase 2 Clinical Trial Examining the Effects on Osteoarthritic Knee Pain of CGS-200-1, CGS-200-5 and Vehicle Control

NCT03528369

Osteoarthritis, Knee Pain

COMPLETED PHASE2

Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee

NCT00108810

Pain Osteoarthritis, Knee

COMPLETED PHASE2

Ketoprofen Topical Patch, 20% in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee

NCT00365586

Osteoarthritis

COMPLETED PHASE3

A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain

NCT03429049

Osteoarthritis, Knee

COMPLETED PHASE3

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

NCT02104050

Osteoarthritis Pain

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a study of a over-the-counter, capsaicin-based (0.25%) topical analgesic for management of osteoarthritis knee pain meeting the US Food and Drug Administration's (FDAs) Tentative Final Monograph (TFM) guidance for "External Analgesic Drug Products For Over-the-Counter Human Use," published in the Federal Register on February 8, 1983 (final proposed 21 CFR 348). Subjects meeting the inclusion criteria and not meeting the exclusion criteria were randomized into one of four groups: once daily treatment with active product, once daily treatment with product vehicle (no capsaicin), twice daily treatment with active product, and twice daily treatment with product vehicle (no capsaicin), all for 7 consecutive days of treatment. The twice daily treatments were spaced approximately 12 hours apart. Both knees received study drug treatment but only one knee per subject was assigned as the "study knee".

Osteoarthritis knee pain was assessed by the 100 mm visual analog scale and the response criterion was a 50% or greater reduction in osteoarthritis knee pain from baseline. Baseline was defined as the visual analog scale recorded not more than 30 minutes before the first study drug application (on Study Day 1). For subjects in the once daily (QD) groups the osteoarthritis knee pain assessments were at 12 hrs after the initial application (during Study Day 1) and 24 hours (Study Day 2) after the initial application and then once in the morning on Study Days 3 - 28. For subjects in the twice daily (BID) groups the osteoarthritis knee pain assessments were at 12 hrs after the initial application (during Study Day 1) and 24 hours(Study Day 2) after the initial application and then once in the morning and once 12 hours later on Study Days 3 - 28.

Tolerability data were also collected as reported burning-stinging pain, erythema and pruritus at the site of application.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Active treatment compared to drug vehicle as placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study medications were number coded only and identical in physical characteristics. Randomization coding was held only at the manufacturing site until data base lock.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Once daily-Active

40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee

Group Type ACTIVE_COMPARATOR

Capsaicin Topical Solution

Intervention Type DRUG

Over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin

Once daily-Vehicle

20 subjects receiving once daily application of drug product vehicle (i.e., with no capsaicin) to the knee

Group Type PLACEBO_COMPARATOR

Drug product vehicle

Intervention Type OTHER

This is the vehicle for the active treatment drug product, but without capsaicin

Twice daily-Active

40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee

Group Type ACTIVE_COMPARATOR

Capsaicin Topical Solution

Intervention Type DRUG

Over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin

Twice daily-Vehicle

20 subjects receiving twice daily application of drug product vehicle (i.e., with no capsaicin) to the knee

Group Type PLACEBO_COMPARATOR

Drug product vehicle

Intervention Type OTHER

This is the vehicle for the active treatment drug product, but without capsaicin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Capsaicin Topical Solution

Over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin

Intervention Type DRUG

Drug product vehicle

This is the vehicle for the active treatment drug product, but without capsaicin

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subject has granted written informed consent.
2. Subject is at least 18 years of age.
3. Subject has knee pain with radiographic evidence of osteoarthritis in at least one knee (including an x-ray within the previous 2 years).
4. Subject's osteoarthritis knee pain has been present for ≥ 6 months.
5. Subject has osteoarthritis knee pain of ≥ 50 mm in one knee based on the visual analog scale at screening.
6. Subject has regularly used topical over-the-counter pain relief products or over-the-counter oral medication (acetaminophen or ibuprofen) to treat/manage pain from osteoarthritis in the previous 3 months.
7. Subject is in good general health and free of any disease state or physical condition which, in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.
8. Subject is capable of understanding and complying with all instructions and study procedures, including the ability to accurately evaluate their symptoms.
9. Subject must be a male or non-pregnant female. If female, subject must be past childbearing age or otherwise must test negative for pregnancy. Males and females must agree to use effective birth control during the study or for at least 30 days after last dose of study investigational product, if unable to complete the study.

Exclusion Criteria

1. Subject has spontaneously improving or rapidly deteriorating osteoarthritis or knee pain.
2. Subject has rheumatoid or psoriatic arthritis, or a form of arthritis inconsistent with a diagnosis of osteoarthritis.
3. Subject has used any topical steroids on or in the vicinity of the knees within 1 week prior to Screening, or has had a knee injection within 1 month prior to Screening.
4. Subject is currently taking prescription pain medication.
5. Subject has shaved their knees within 2 days of first day of treatment (Day 1).
6. Subject has used any capsaicin containing product on or in the vicinity of the knees within 2 weeks prior to first day of treatment (Day 1).
7. Subject has used any topically applied products (including emollient/moisturizer) on or in the vicinity of the knees within 2 weeks prior to first day of treatment (Day 1).
8. Subject has used topical therapy on the knees that, in the investigator's opinion, might affect the study evaluations of signs and/or symptoms.
9. Subject has broken or damaged skin on their knees, or an open wound near the knees.
10. Subject has a history of allergy/sensitivity to topical substances.
11. Subject is not able to understand the nature, importance, or consequences of the study.
12. Subject has a psychiatric disorder or has significant anxiety or depression that, in the investigator's opinion, could interfere with the subject's ability to accurately assess their pain, adhere to study instructions, or complete the study.
13. Subject has hypertension that is not adequately controlled (medication to treat hypertension is allowed), vascular disease, psychological disorder, or other condition that, in the investigator's opinion, contraindicate the use of medication.
14. Is obese with a Body Mass Index (BMI) of greater than 40 kg/m2.
15. Subject requires a surgical procedure in the immediate future.
16. Subject is pregnant or nursing.
17. Subject has been treated with an investigational drug, device, or therapy within 30 days prior to first day of treatment (Day 1).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No