OsteoarthritisPhase 2NCT01341405
Study of CG100649 Versus Celecoxib in Osteoarthritis Patients
A Phase 2 study testing CG100649 and Celecoxib in people with Osteoarthritis, run by CrystalGenomics, Inc. at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- CG100649 and Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2011to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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);
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- 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;
- History of seizure disorder;
- Subjects with serious psychosocial co-morbidities;
- Subjects with gastrointestinal, renal, hepatic, or coagulant disorder within 6 months of screening;
- Esophageal or duodenal ulcer within 6 months of screening;
- History of nasal polyps, bronchospasm, and urticaria;
- Pregnant or breast-feeding;
- Subject with genetic problem of galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption (because celecoxib contains lactose)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Multicenter, Noninferiority, Phase II Repeat Dose Study of CG100649 Versus Celecoxib in Osteoarthritis Patients
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).
Read the detailed description
This is a double-blind, randomized, multicenter, noninferiority, phase 2 study. Subjects will discontinue current medications (NSAID or COX-2 inhibitor) 5-14 days prior to randomization. Paracetamol (acetaminophen; ≤2 gm/day) may be used for breakthrough pain. Other NSAIDs, COX-2 inhibitors, opioids, and corticosteroids may not be used at any time during this study. Only subjects recording average WOMAC pain score of 4 to 8 on a 0-10 numerical rating scale during the washout period and meeting all other inclusion criteria will be randomized into the study.
Male and female adults, ages 20 and older, with a history of osteoarthritis (OA) of the knee or hip diagnosed by radiograph obtained within the past 20 years and with pain at least 3 months from OA can participate in this study. OA must be confirmed by radiographs and diagnosed according to American College of Rheumatology (ACR) guidelines. Subjects must qualify as ACR global functional status I, II, or III (excluding IV) and Kellgren-Lawrence grade 1, 2 or 3 (excluding grade 4).
Subjects meeting screening criteria will be randomized to receive 28 days dosing of an active dose of CG100649 or comparator (celecoxib).
Antiarthritic efficacy will be evaluated by changes in the Western Ontario and McMaster Universities (WOMAC) OA index completed on Day 1 (Baseline) and on Days 14, 28 and 42. The WOMAC pain subscale will be evaluated at screening and on Days 1, 7, 14, 21, 28, 35 and 42.
All doses will be administered orally once daily in the morning. There are 3 planned treatment arms (2 with active compound + one comparator (celecoxib) group) with n=44 per treatment arm. Total number of subjects will be 132.
Treatment A: CG100649: 2 mg/day (Days 1-28); Treatment B: CG100649: 4 mg/day (Days 1-28); Treatment C: celecoxib: 200 mg/day (Days 1-28); Active and comparator medications will have identical appearance.
- Conditions
- Osteoarthritis
- Being tested
- CG100649, Celecoxib
- Keywords
- COX-1, COX-2, carbonic anhydrase, anti-inflammatory, Cyclooxygenase Inhibitors, Polmacoxib
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG100649Drug
Also called CG100649 2mg, CG100649 4mg
once daily for 28 days
CelecoxibDrug
Also called Celebrex
capsule, celecoxib 200 mg, once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| CG100649 2 mg | Experimental | capsule, once daily for 28 days Receives: Drug: CG100649 |
| CG100649 4 mg | Experimental | capsule, once daily for 28 days Receives: Drug: CG100649 |
| celecoxib 200 mg | Active comparator | capsule, once daily for 28 days Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 28
Secondary outcomes (3)
Change of the Sum of WOMAC OA Index at Day 28 From Baseline
The numerical rating scale version of the Western Ontario and McMaster Universities (WOMAC) OA index will be used-i.e., with the patient assessing each question by a 11-point (0-10) numerical rating scale, and the total index score being represented by the sum of the 24 component item scores. A higher WOMAC score represents worse symptom severity, with 240 being the worst possible total score (minimum total: 0 point, maximum total: 240 points).
Measured: Baseline, Day 28
Change of WOMAC-Stiffness Subscale at Day 28 From Baseline
Version 3.1 of the WOMAC knee and hip osteoarthritis index translated in Korean language was used to evaluate the stiffness of the index joint. Two questions were to evaluate "Stiffness" of the index joint. A higher WOMAC-Stiffness score represents worse symptom severity, with 20 being the worst possible total score (minimum total: 0 point, maximum total: 20 points).
Measured: Baseline, Day 28
Change of WOMAC-Physical Function Subscale at Day 28 From Baseline
Version 3.1 of the WOMAC knee and hip osteoarthritis index translated in Korean language was used. The total 17 questions to evaluate "Physical Function." A higher score of WOMAC-Physical function subscale represents worse symptom severity, with 170 being the worst possible total score (minimum total: 0 point, maximum total: 170 points).
Measured: Baseline, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- CrystalGenomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sangsook Cho, Ph.D., Study director, CrystalGenomics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341405
- Sponsor's protocol ID
- CG100649-2-02
- Status last verified
- May 2022
- First submitted
- 22 Apr 2011
- Last updated
- 9 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Multicenter, Noninferiority, Phase II Repeat Dose Study of CG100649 Versus Celecoxib in Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT01341405
- Acronym / sponsor ID
- CG100649-2-02
- Conditions
- Osteoarthritis
- Keywords
- COX-1, COX-2, carbonic anhydrase, anti-inflammatory, Cyclooxygenase Inhibitors, Polmacoxib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- CrystalGenomics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Apr 2011 (estimated)
- Results
- Posted 9 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a double-blind, randomized, multicenter, noninferiority, phase 2 study. Subjects will discontinue current medications (NSAID or COX-2 inhibitor) 5-14 days prior to randomization. Paracetamol (acetaminophen; ≤2 gm/day) may be used for breakthrough pain. Other NSAIDs, COX-2 inhibitors, opioids, and corticosteroids may not be used at any time during this study. Only subjects recording average WOMAC pain score of 4 to 8 on a 0-10 numerical rating scale during the washout period and meeting all other inclusion criteria will be randomized into the study.
Male and female adults, ages 20 and older, with a history of osteoarthritis (OA) of the knee or hip diagnosed by radiograph obtained within the past 20 years and with pain at least 3 months from OA can participate in this study. OA must be confirmed by radiographs and diagnosed according to American College of Rheumatology (ACR) guidelines. Subjects must qualify as ACR global functional status I, II, or III (excluding IV) and Kellgren-Lawrence grade 1, 2 or 3 (excluding grade 4).
Subjects meeting screening criteria will be randomized to receive 28 days dosing of an active dose of CG100649 or comparator (celecoxib).
Antiarthritic efficacy will be evaluated by changes in the Western Ontario and McMaster Universities (WOMAC) OA index completed on Day 1 (Baseline) and on Days 14, 28 and 42. The WOMAC pain subscale will be evaluated at screening and on Days 1, 7, 14, 21, 28, 35 and 42.
All doses will be administered orally once daily in the morning. There are 3 planned treatment arms (2 with active compound + one comparator (celecoxib) group) with n=44 per treatment arm. Total number of subjects will be 132.
Treatment A: CG100649: 2 mg/day (Days 1-28); Treatment B: CG100649: 4 mg/day (Days 1-28); Treatment C: celecoxib: 200 mg/day (Days 1-28); Active and comparator medications will have identical appearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CG100649 2 mg | Experimental | Drug: CG100649capsule, once daily for 28 days |
| CG100649 4 mg | Experimental | Drug: CG100649capsule, once daily for 28 days |
| celecoxib 200 mg | Active comparator | Drug: Celecoxibcapsule, once daily for 28 days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CG100649Also: CG100649 2mg, CG100649 4mgonce daily for 28 days | Drug | CG100649 2 mg, CG100649 4 mg |
| CelecoxibAlso: Celebrexcapsule, celecoxib 200 mg, once daily for 28 days | Drug | celecoxib 200 mg |
Primary outcome
Change of the WOMAC Pain Subscale at Day 28 From Baseline
Time frame: Baseline, Day 28
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.
3 secondary outcomes
Change of the Sum of WOMAC OA Index at Day 28 From Baseline
Time frame: Baseline, Day 28
Change of WOMAC-Stiffness Subscale at Day 28 From Baseline
Time frame: Baseline, Day 28
Change of WOMAC-Physical Function Subscale at Day 28 From Baseline
Time frame: Baseline, Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangsook Cho, Ph.D. study director
CrystalGenomics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CG100649 and Celecoxib in people with Osteoarthritis, run by CrystalGenomics, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the WOMAC Pain Subscale at Day 28 From Baseline (time frame: Baseline, Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.