Phase III Study of CG100649 in Osteoarthritis Patients
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ClinicalTrials.gov Identifier: NCT01765296 |
Recruitment Status : Unknown
Verified April 2013 by CrystalGenomics, Inc..
Recruitment status was: Recruiting
First Posted : January 10, 2013
Last Update Posted : April 30, 2013
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- 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.
Condition or disease | Intervention/treatment | Phase |
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Localized Primary Osteoarthritis of Hip Localized Primary Osteoarthritis of Knee | Drug: CG100649 Drug: Celecoxib Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 350 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Double-blind, Randomized, Multicenter, Active- and Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of CG100649 in Osteoarthritis Patients |
Study Start Date : | March 2013 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | March 2014 |

Arm | Intervention/treatment |
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Active Comparator: 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)
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Drug: CG100649
2 mg capsule Drug: Celecoxib 200 mg capsule
Other Name: Celebrex |
Placebo Comparator: Placebo
Placebo capsule by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase)
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Drug: CG100649
2 mg capsule Drug: Placebo Mimic for CG100649 2 mg capsule and for celecoxib 200 mg capsule |
Experimental: 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)
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Drug: CG100649
2 mg capsule |
- WOMAC-Pain Subscale in the index joint [ Time Frame: 6 weeks ]The primary efficacy outcome measure will be the change in the WOMAC-Pain Subscale in the index joint at W6 (Day 42) vs. Day 1 (Visit 2, pre-dose Baseline).
- WOMAC Osteoarthritis (OA) Index [ Time Frame: Weeks 3 and 6 ]• Change in the WOMAC OA index at W3 and W6 vs. pre-dose Baseline;
- WOMAC Osteoarthritis Subscales [ Time Frame: Weeks 3 and 6 ]• Change in WOMAC OA subscales (pain, stiffness, physical function) at W3 and W6 vs. pre-dose Baseline;
- Subject's Global Assessment (SGA) [ Time Frame: Weeks 3 and 6 ]• Subject's Global Assessment at W3 and W6 vs. pre-dose Baseline;
- Physician's Global Assessment (PGA) [ Time Frame: Weeks 3 and 6 ]• Physician's Global Assessment at W3 and W6 vs. pre-dose Baseline;
- Withdrawals [ Time Frame: Weeks 3 and 6 ]• Withdrawals due to lack of analgesic efficacy.
- Safety Measures of Extended Safety Study [ Time Frame: 24 weeks ]
- Adverse events (AEs)
- Vital signs (BP, pulse rate, body temperature), 12-lead ECG
- Clinical laboratory tests (hematology, chemistry, coagulation, urinalysis), physical examination

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (abbreviated)
- Males or females, age 20 years or above, able and willing to provide written informed consent
- Knee or Hip OA diagnosed according to American College of Rheumatology guidelines
- Chronic pain for ≥3 months from OA
- BP [systolic 90-140 mmHg, diastolic 50-90 mmHg] and pulse rate [resting 40-100 bpm].
- WOMAC-Pain score in the index joint must be between 4-8 on a 0-10 numerical rating scale
- Blood chemistry must be within 2x normal range
- Urinalysis must be within normal limits; minor deviations are acceptable
- 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
- For prior non-steroidal inflammatory drug (NSAID) users only, the subject has a history of positive therapeutic benefit
- Subject is willing to limit alcohol intake to 2 or less drinks per day during study and the follow-up period
- Subjects must be able to read, understand and follow study related documents.
Exclusion Criteria (abbreviated)
- Use of any analgesics except the study medication or acetaminophen at any time
- 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.
- Subject is legally incompetent, or has active psychosis, or significant emotional problems which are sufficient to interfere with the conduct of the study
- Use of anticoagulants (aspirin, warfarin, heparin, etc.) within 2 weeks of V1
- Previous history of hypersensitivity or allergy to NSAIDs, COX-2 inhibitors, carbonic anhydrase inhibitors, sulfa drugs, aspirin, or acetaminophen/paracetamol
- 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
- Diagnosed or treated for active GI ulcer, GI bleeding, ulcerative colitis, or severe renal, hepatic, or coagulant disorder within 6 months prior to randomization
- History of nasal polyps, bronchospasm, urticaria, or anaphylactic shock
- 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
- Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study
- Subjects who are currently participating or have participated in other clinical studies within 4 weeks of screening or in any other clinical trial evaluating NSAIDs or COX-2 inhibitors within 6 months of screening
- Subjects who have received even one dose of rofecoxib or etoricoxib at any time in their life
- History of congestive heart failure with a status of New York Heart Association II-IV, ischemic heart disease, uncontrolled hypertension, peripheral arterial disease, cerebrovascular disease or subjects who have one of these diseases
- Current user of recreational or illicit drugs or has had a recent history (1 year) of drug or alcohol abuse or dependence
- History of neoplastic disease or chemotherapy within 5 years of V1, with the exception of non-metastatic skin cancer that has been completely cured
- Subjects with gout, pseudogout, inflammatory arthritis, Paget's disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
- Subjects using i.v, i.m., or oral corticosteroids, i.a. steroids or hyaluronic acid injections within 1 month of V1
- Subjects receiving a Chinese traditional arthritis treatment within 1 week of V1
- Subjects who are not suitable to participate in the study by the investigator's clinical decision

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765296
Contact: Su Jeong Yang | sjyang@cgxinc.com | ||
Contact: Seonggu Ro, PhD | sgro@cgxinc.com |
Korea, Republic of | |
Kyungpook National University Hospital | Recruiting |
Daegu, Korea, Republic of | |
Contact: Hee Soo Kyung, MD, PhD +82 53-200-0000 | |
Principal Investigator: Hee Soo Kyung, MD, PhD | |
Chungnam National University Hospital | Recruiting |
Daejeon, Korea, Republic of, 301-721 | |
Contact: Young Mo Kim, MD, PhD +82 53-200-0000 | |
Principal Investigator: Young Mo Kim, MD, PhD | |
NHIC Ilsan Hospital | Recruiting |
Goyang-si, Korea, Republic of, 410-719 | |
Contact: Ju Hyung Yoo, MD, PhD +82 31-900-0000 | |
Principal Investigator: Ju Hyung Yoo, MD, PhD | |
Gachon University Gil Medical Center | Recruiting |
Incheon, Korea, Republic of | |
Contact: Beom Koo Lee, MD, PhD +82 32-460-0000 | |
Principal Investigator: Beom Koo Lee, MD, PhD | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 110-744 | |
Contact: Myung Chul Lee, MD, PhD +82 2 2072-0000 | |
Principal Investigator: Myung Chul Lee, MD, PhD | |
Hanyang University Hospital | Recruiting |
Seoul, Korea, Republic of, 133-792 | |
Contact: Choong Hyeok Choi, MD 82 2-2290-0000 | |
Principal Investigator: Choong Hyeok Choi, MD, PhD | |
Gangnam Severance Hospital | Recruiting |
Seoul, Korea, Republic of, 135-720 | |
Contact: Chong Hyuk Choi, MD, PhD +82 10 9016-0000 | |
Principal Investigator: Chong Hyuk Choi, MD, PhD | |
Seoul St. Mary's Hospital | Recruiting |
Seoul, Korea, Republic of, 137-701 | |
Contact: In Yong, MD, PhD +82 2-2258-0000 | |
Principal Investigator: In Yong, MD, PhD | |
Asan Medical Center | Recruiting |
Seoul, Korea, Republic of, 138-736 | |
Contact: Seong-Il Bin, MD, PhD +82 2 3010 0000 | |
Principal Investigator: Seong-Il Bin, MD, PhD | |
Boramae Medical Center | Recruiting |
Seoul, Korea, Republic of, 156-707 | |
Contact: Seung Baik Kang, MD, PhD +82 2-870-0000 | |
Principal Investigator: Seung Baik Kang, MD, PhD | |
Ewha Womans University Hospital | Recruiting |
Seoul, Korea, Republic of, 158-710 | |
Contact: Jong Oh Kim, MD, PhD +82 2 2650-0000 | |
Principal Investigator: Jong Oh Kim, MD, PhD | |
Inje University Seoul Paik Hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Jin Goo Kim, MD, PhD +82 2-2270-0000 | |
Principal Investigator: Jin Goo Kim, MD, PhD | |
Korea University Anam Hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Seung Beom Han, MD, PhD +82 2-920-0000 | |
Principal Investigator: Seung Beom Han, MD, PhD | |
Samsung Medical Center | Recruiting |
Seoul, Korea, Republic of | |
Contact: Young Wan Moon, MD, PhD +82 2-3410-0000 | |
Principal Investigator: Young Wan Moon, MD, PhD |
Study Director: | Seonggu Ro, PhD | CrystalGenomics, Inc. | |
Principal Investigator: | Myung Chul Lee, MD, PhD | Seoul National University Hospital |
Responsible Party: | CrystalGenomics, Inc. |
ClinicalTrials.gov Identifier: | NCT01765296 |
Other Study ID Numbers: |
CG100649-3-01 |
First Posted: | January 10, 2013 Key Record Dates |
Last Update Posted: | April 30, 2013 |
Last Verified: | April 2013 |
Osteoarthritis Osteoarthritis, Knee Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Celecoxib Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |