Study of CG100649 Versus Celecoxib in Osteoarthritis Patients

NCT01341405 | Completed Phase 2 Results DMC

• 1 other identifier: CG100649-2-02
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind, randomized, multicenter, phase 2b, noninferiority comparison of two active dose levels of CG100649 vs. a standard anti-arthritic dose of celecoxib (Celebrex).

Conditions

Osteoarthritis

Keywords

COX-1; COX-2; carbonic anhydrase; anti-inflammatory; Cyclooxygenase Inhibitors; Polmacoxib

Outcome Measures

Primary Outcomes (1)

• Change of the WOMAC Pain Subscale at Day 28 From Baseline

  Changes in the WOMAC Pain Score from Baseline The primary endpoint of this study was the change in the sum of the WOMAC Pain subscale at Day 28 vs. Baseline (Day 1) using the ITT population). Pain scores were evaluated using the WOMAC Pain subscale, which provided an evaluation of pain during the past 48 hours using a 0-10 numerical rating scale for each of 5 questions (minimum total: 0 point, maximum total: 50 points). A higher WOMAC Pain score represented worse symptom severity.

  Baseline, Day 28

Secondary Outcomes (3)

• Change of the Sum of WOMAC OA Index at Day 28 From Baseline

  Baseline, Day 28

• Change of WOMAC-Stiffness Subscale at Day 28 From Baseline

  Baseline, Day 28

• Change of WOMAC-Physical Function Subscale at Day 28 From Baseline

  Baseline, Day 28

Study Arms (3)

CG100649 2 mg

EXPERIMENTAL

capsule, once daily for 28 days

Drug: CG100649

CG100649 4 mg

EXPERIMENTAL

capsule, once daily for 28 days

Drug: CG100649

celecoxib 200 mg

ACTIVE COMPARATOR

capsule, once daily for 28 days

Drug: Celecoxib

Interventions

CG100649 DRUG

once daily for 28 days

Also known as: CG100649 2mg, CG100649 4mg

CG100649 2 mg; CG100649 4 mg

Celecoxib DRUG

capsule, celecoxib 200 mg, once daily for 28 days

Also known as: Celebrex

celecoxib 200 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, age 20 years old and more, able and willing to provide written informed consent to participate in the study
• Confirmed osteoarthritis (OA) of the knee or hip by radiograph obtained within the past 20 years and diagnosed according to American College of Rheumatology (ACR) guidelines.
• Subject must have pain at least 3 month duration from osteoarthritis (OA)
• Normal blood pressure (BP) \[systolic BP 90-140 mmHg, diastolic BP 50-90 mmHg\] and heart rate (HR) \[resting 45-90 beats per minute (bpm)\]
• Subjects with hypertension should have stably taken ACE inhibitor, angiotensin II receptor (type AT1) antagonist, beta-blocker and/or diuretics at least 3 months at the time of screening in order to keep normal blood pressure. Subjects should not change or stop hypertension drug during the study.
• Clinical Chemistry must be within 2x normal limits
• Urinalysis must be within normal range.
• Prior to randomization on Day 1, the mean WOMAC pain score in the index joint must be between 4 and 8 on a 0-10 numerical rating scale.
• Subjects and their sexual partners must agree to use double barrier contraception during the study period and for 3 months afterwards or provide proof of surgical sterility or post-menopause more than 1 year.
• Subject must be able to read and understand and follow the study instructions.

You may not qualify if:

• Use of any analgesics except the study medication or paracetamol (acetaminophen) at any time during this study;
• Use of corticosteroids or intra-articular viscosupplementation within 3 months of screening;
• Use of antidepressants or anticonvulsants within 2 months of screening;
• Cognitive or psychiatric disorders, or daytime use of medications (alcohol, benzodiazepines, barbiturates, muscle relaxants) that could diminish compliance with study procedures;
• Use of anticoagulants (aspirin, warfarin, heparin) within 2 weeks of screening;
• Use of any medications that will affect pain perception (e.g. tranquilizers, hypnotics);
• Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase (COX)-2 inhibitors, or carbonic anhydrase inhibitors;
• Use of oriental medicine (herbal medicine) or glucosamine within 14 days of dose administration
• History of drug or alcohol abuse within one year prior to screening;
• Known allergy or hypersensitivity to sulfa drugs;
• History of congestive heart failure, ischemic heart disease, peripheral arterial disease, cerebrovascular disease or subjects who have one of these diseases;
• Use of chemotherapy agents or history of cancer, other than non-metastatic skin cancer that has been completely excised, within five (5) years prior to the screening visit;
• Subjects with gout, pseudogout, inflammatory arthritis, Paget's disease, chronic pain syndrome, fibromyalgia, or another major joint disease;
• 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;
• Subjects who have had surgery on the affected joint within 6 months of screening and subjects with a prosthesis at the index joint;

Sponsors & Collaborators

• CrystalGenomics, Inc.: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

CG100649; Celecoxib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Sang-Yoon Lee, M.D.
• Organization: CrystalGenomics, Inc

sang-yoon.lee@cgxinc.com

82-31-628-2871

Study Officials

• Sangsook Cho, Ph.D.

  CrystalGenomics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2011
• First Posted: April 25, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: February 9, 2023
• Results First Posted: February 9, 2023

Record last verified: 2022-05

Locations

KR (1)