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Phase III Study of CG100649 in Osteoarthritis Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Phase III Study of CG100649 in Osteoarthritis Patients

A Double-blind, Randomized, Multicenter, Active- and Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of CG100649 in Osteoarthritis Patients

NCT01765296•CrystalGenomics, Inc.

View on ClinicalTrials.gov

Summary

* 6-week Efficacy Study The objective of this study is to prove the safety and non-inferiority of analgesic efficacy of CG100649 2 mg vs. celecoxib 200 mg, and analgesic superiority of CG100649 2 mg vs. placebo, when administered once a day in patients with osteoarthritis of the hip or knee over the 6 week Treatment period. The primary efficacy parameter is the difference from Baseline to Week 6 in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC)-Pain subscale. * Extended Safety Study The objective of the Extended Safety Study is to collect a total of 24 weeks of safety data for CG100649 including the initial 6 weeks of safety data, and an additional 18 weeks of safety data for those subjects who agree on the consent form to continue into the Extended Safety Study. Subjects will be administered CG100649 2 mg only during 18 weeks of Extended Safety Study.

Detailed Description

1. Number of Subjects: 350 (2:2:1 ratio of experimental vs. active comparator vs. placebo comparator) 2. Adverse Events will be coded to preferred term and body system using the Medical Dictionary for Regulatory Activities (MedDRA)

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males or females, age 20 years or above, able and willing to provide written informed consent
•2. Knee or Hip OA diagnosed according to American College of Rheumatology guidelines
•3. Chronic pain for ≥3 months from OA
•4. BP \[systolic 90-140 mmHg, diastolic 50-90 mmHg\] and pulse rate \[resting 40-100 bpm\].
•5. WOMAC-Pain score in the index joint must be between 4-8 on a 0-10 numerical rating scale
•6. Blood chemistry must be within 2x normal range
•7. Urinalysis must be within normal limits; minor deviations are acceptable
•8. Subjects and their sexual partners must agree to use double barrier contraception during the study period and for 3 months afterward, or be at least one year post- menopause, or provide proof of surgical sterility
•9. For prior non-steroidal inflammatory drug (NSAID) users only, the subject has a history of positive therapeutic benefit
•10. Subject is willing to limit alcohol intake to 2 or less drinks per day during study and the follow-up period
+1 more criteria

Exclusion Criteria

•1. Use of any analgesics except the study medication or acetaminophen at any time
•2. Use of any medications for ongoing chronic symptoms, or psychiatric disorders that could significantly diminish the cognitive ability or cause behavioral changes that would prevent the subject from complying with study procedures.
•3. Subject is legally incompetent, or has active psychosis, or significant emotional problems which are sufficient to interfere with the conduct of the study
•4. Use of anticoagulants (aspirin, warfarin, heparin, etc.) within 2 weeks of V1
•5. Previous history of hypersensitivity or allergy to NSAIDs, COX-2 inhibitors, carbonic anhydrase inhibitors, sulfa drugs, aspirin, or acetaminophen/paracetamol
•6. Subjects requiring knee or hip arthroplasty within 2 months of screening or anticipating any need for a surgical procedure on the index joint during the study
•7. Diagnosed or treated for active GI ulcer, GI bleeding, ulcerative colitis, or severe renal, hepatic, or coagulant disorder within 6 months prior to randomization
•8. History of nasal polyps, bronchospasm, urticaria, or anaphylactic shock
•9. Subjects who have had surgery on the affected joint within 6 months prior to the study and subjects with a prosthesis at the index joint
•10. Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study
+9 more criteria

Locations (14)

Kyungpook National University Hospital

Daegu, South Korea

Chungnam National University Hospital

Daejeon, South Korea

NHIC Ilsan Hospital

Goyang-si, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Seoul National University Hospital

Seoul, South Korea

Hanyang University Hospital

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Seoul St. Mary's Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Boramae Medical Center

Seoul, South Korea

Key Dates

Start Date

March 1, 2013

Primary Completion Date

December 1, 2013

Completion Date

April 1, 2014

Last Updated

February 15, 2023

Enrollment

362

ACTUAL participants

Conditions

Localized Primary Osteoarthritis of HipLocalized Primary Osteoarthritis of Knee

Interventions

CG100649

DRUG

Celecoxib

DRUG

Placebo

DRUG