Phase III Study of CG100649 in Osteoarthritis Patients

Phase 3

Completed

• Conditions: Localized Primary Osteoarthritis of Knee; Localized Primary Osteoarthritis of Hip
• Interventions: Drug: CG100649; Drug: Placebo; Drug: Celecoxib

• Registration Number: NCT01765296
• Lead Sponsor: CrystalGenomics, Inc.

Brief 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)

Study Timeline

• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-10
• Study Start: 2013-03
• Primary Completion: 2013-12
• Study Completion: 2014-04
• Results First Submitted: 2016-07-25
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-13
• Last Update Submitted: 2023-02-13
• Results First Posted: 2023-02-15
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CG100649	CG100649	CG100649 2 mg capsule by mouth, once a day for 6 weeks (Treatment Phase); CG100649 2 mg capsule by mouth, once a day for 18 weeks (Safety Phase)
Placebo	Placebo	Placebo capsule by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase)
Celecoxib	Celecoxib	Celecoxib 200 mg by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase)

Primary Outcome Measures

Name	Time	Method
Change in WOMAC-Pain Subscale	Baseline, Week 6	Western Ontario and McMaster Universities (WOMAC) OA index. Version 3.1 of the WOMAC knee and hip osteoarthritis index translated in Korean language will be used for each site enrolled in the trial.; The numerical rating scale version of the WOMAC-Pain subscale was used, i.e., with the subject assessing each question by a 11-point (0-10) numerical rating scale, and the total pain score being represented by the sum of the 5 component item scores. A higher WOMAC score represented worse symptom severity, with 50 being the worst possible total score.

Secondary Outcome Measures

Name	Time	Method
Change of the WOMAC-physical Function Subscale at Week 3 and 6 From Pre-dose Baseline	Baseline, Week 3 and Week 6	Western Ontario and McMaster Universities (WOMAC) OA index. Version 3.1 of the WOMAC knee and hip osteoarthritis index translated in Korean language will be used for each site enrolled in the trial.; The 24 questions, which measure with 0-10 point numerical rating scale (NRS) with a maximum of 240 points to evaluate "Pain (5 questions)," "Stiffness (2 questions)," and "Physical Function (17 questions)" in WOMAC 3.1.; Total scores for WOMAC-physical function is from 0 to 170 points. A higher WOMAC score represented worse symptom severity.

Trial Locations

Locations (14)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

NHIC Ilsan Hospital; 🇰🇷 Goyang-si, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Hanyang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Ewha Womans University Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Inje University Seoul Paik Hospital; 🇰🇷 Seoul, Korea, Republic of