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Trial record 6 of 511 for:    Open Studies | "Osteoarthritis"

Phase III Study of CG100649 in Osteoarthritis Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by CrystalGenomics, Inc.
Sponsor:
Information provided by (Responsible Party):
CrystalGenomics, Inc.
ClinicalTrials.gov Identifier:
NCT01765296
First received: January 8, 2013
Last updated: April 27, 2013
Last verified: April 2013
  Purpose
  • 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 Intervention Phase
Localized Primary Osteoarthritis of Hip
Localized Primary Osteoarthritis of Knee
Drug: CG100649
Drug: Celecoxib
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by CrystalGenomics, Inc.:

Primary Outcome Measures:
  • WOMAC-Pain Subscale in the index joint [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • WOMAC Osteoarthritis (OA) Index [ Time Frame: Weeks 3 and 6 ] [ Designated as safety issue: No ]
    • Change in the WOMAC OA index at W3 and W6 vs. pre-dose Baseline;

  • WOMAC Osteoarthritis Subscales [ Time Frame: Weeks 3 and 6 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • Subject's Global Assessment at W3 and W6 vs. pre-dose Baseline;

  • Physician's Global Assessment (PGA) [ Time Frame: Weeks 3 and 6 ] [ Designated as safety issue: No ]
    • Physician's Global Assessment at W3 and W6 vs. pre-dose Baseline;

  • Withdrawals [ Time Frame: Weeks 3 and 6 ] [ Designated as safety issue: No ]
    • Withdrawals due to lack of analgesic efficacy.


Other Outcome Measures:
  • Safety Measures of Extended Safety Study [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    1. Adverse events (AEs)
    2. Vital signs (BP, pulse rate, body temperature), 12-lead ECG
    3. Clinical laboratory tests (hematology, chemistry, coagulation, urinalysis), physical examination


Estimated Enrollment: 350
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: CG100649
2 mg capsule
Other Name: CG100649
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)
Drug: CG100649
2 mg capsule
Other Name: CG100649
Drug: Placebo
Mimic for CG100649 2 mg capsule and for celecoxib 200 mg capsule
Other Name: Placebo
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)
Drug: CG100649
2 mg capsule
Other Name: CG100649

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (abbreviated)

  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
  11. Subjects must be able to read, understand and follow study related documents.

Exclusion Criteria (abbreviated)

  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
  11. 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
  12. Subjects who have received even one dose of rofecoxib or etoricoxib at any time in their life
  13. 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
  14. Current user of recreational or illicit drugs or has had a recent history (1 year) of drug or alcohol abuse or dependence
  15. History of neoplastic disease or chemotherapy within 5 years of V1, with the exception of non-metastatic skin cancer that has been completely cured
  16. Subjects with gout, pseudogout, inflammatory arthritis, Paget's disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
  17. Subjects using i.v, i.m., or oral corticosteroids, i.a. steroids or hyaluronic acid injections within 1 month of V1
  18. Subjects receiving a Chinese traditional arthritis treatment within 1 week of V1
  19. Subjects who are not suitable to participate in the study by the investigator's clinical decision
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765296

Contacts
Contact: Su Jeong Yang sjyang@cgxinc.com
Contact: Seonggu Ro, PhD sgro@cgxinc.com

Locations
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 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         
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         
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         
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         
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         
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         
Sponsors and Collaborators
CrystalGenomics, Inc.
Investigators
Study Director: Seonggu Ro, PhD CrystalGenomics, Inc.
Principal Investigator: Myung Chul Lee, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: CrystalGenomics, Inc.
ClinicalTrials.gov Identifier: NCT01765296     History of Changes
Other Study ID Numbers: CG100649-3-01
Study First Received: January 8, 2013
Last Updated: April 27, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014