Localized Primary Osteoarthritis of HipPhase 3NCT01765296

Phase III Study of CG100649 in Osteoarthritis Patients

A Phase 3 study testing CG100649 and Celecoxib in people with Localized Primary Osteoarthritis of Hip and Localized Primary Osteoarthritis of Knee, run by CrystalGenomics, Inc. at 14 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Localized Primary Osteoarthritis of Hip, Localized Primary Osteoarthritis of Knee
What is being tested?: CG100649 and Celecoxib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 362 participants
Where: 14 sitesSouth Korea
Study dates: Mar 2013to Apr 2014
Phase: Phase 3
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 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

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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.

Who cannot join

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

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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

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

South Korea14 sites

Kyungpook National University Hospital
Daegu
Chungnam National University Hospital
Daejeon, 301-721
NHIC Ilsan Hospital
Goyang-si, 410-719
Gachon University Gil Medical Center
Incheon
Seoul National University Hospital
Seoul, 110-744
Hanyang University Hospital
Seoul, 133-792
Gangnam Severance Hospital
Seoul, 135-720
Seoul St. Mary's Hospital
Seoul, 137-701
Asan Medical Center
Seoul, 138-736
Boramae Medical Center
Seoul, 156-707
Ewha Womans University Hospital
Seoul, 158-710
Inje University Seoul Paik Hospital
Seoul
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul

Other trials in South Korea

About this study

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

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.

Read the detailed description

Number of Subjects: 350 (2:2:1 ratio of experimental vs. active comparator vs. placebo comparator)
Adverse Events will be coded to preferred term and body system using the Medical Dictionary for Regulatory Activities (MedDRA)

Conditions: Localized Primary Osteoarthritis of Hip, Localized Primary Osteoarthritis of Knee
Being tested: CG100649, Celecoxib, Placebo
Keywords: COX-1, COX-2, carbonic anhydrase, anti-inflammatory, Cyclooxygenase Inhibitors, Polmacoxib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CG100649Drug
2 mg capsule
CelecoxibDrug
Also called Celebrex
200 mg capsule
PlaceboDrug
Mimic for CG100649 2 mg capsule and for celecoxib 200 mg capsule

Study groups in NCT01765296
Study group	Role	What they receive
Celecoxib	Active comparator	Celecoxib 200 mg by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase) Receives: Drug: Celecoxib
Placebo	Placebo comparator	Placebo capsule by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase) Receives: Drug: Placebo
CG100649	Experimental	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) Receives: Drug: CG100649

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in WOMAC-Pain Subscale
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.
Measured: Baseline, Week 6

Secondary outcomes (1)

Change of the WOMAC-physical Function Subscale at Week 3 and 6 From Pre-dose Baseline
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.
Measured: Baseline, Week 3 and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Apr 2014

First posted10 Jan 2013 (estimated)
Study startMar 2013
Primary completionDec 2013
Study completionApr 2014

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 Localized Primary Osteoarthritis of HipStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 362 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01765296
Sponsor's protocol ID: CG100649-3-01
Status last verified: Feb 2023
First submitted: 8 Jan 2013
Last updated: 15 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: This medication already got NDA approval in Korea

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01765296
Acronym / sponsor ID: CG100649-3-01
Conditions: Localized Primary Osteoarthritis of Hip, Localized Primary Osteoarthritis of Knee
Keywords: COX-1, COX-2, carbonic anhydrase, anti-inflammatory, Cyclooxygenase Inhibitors, Polmacoxib
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 362 participants (actual)
Lead sponsor: CrystalGenomics, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Dec 2013 (actual)
Study completion: Apr 2014 (actual)
First posted: 10 Jan 2013 (estimated)
Results: Posted 15 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Number of Subjects: 350 (2:2:1 ratio of experimental vs. active comparator vs. placebo comparator)
Adverse Events will be coded to preferred term and body system using the Medical Dictionary for Regulatory Activities (MedDRA)

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
Celecoxib	Active comparator	Drug: CelecoxibCelecoxib 200 mg by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase)
Placebo	Placebo comparator	Drug: PlaceboPlacebo capsule by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase)
CG100649	Experimental	Drug: CG100649CG100649 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)

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (19 listed)

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

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
CG1006492 mg capsule	Drug	CG100649
CelecoxibAlso: Celebrex200 mg capsule	Drug	Celecoxib
PlaceboMimic for CG100649 2 mg capsule and for celecoxib 200 mg capsule	Drug	Placebo

Primary outcome

Change in WOMAC-Pain Subscale
Time frame: 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.

1 secondary outcome

Change of the WOMAC-physical Function Subscale at Week 3 and 6 From Pre-dose Baseline
Time frame: Baseline, Week 3 and Week 6

Results and safety

Results posted to the registry on 15 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	71	66
CG100649	146	126
Celecoxib	145	132

Primary outcome: Change in WOMAC-Pain Subscale

Time frame: Baseline, Week 6. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 71	CG100649 2 mg n = 146	Celecoxib 200 mg n = 145
Baseline	26.8 (4.58)	27.9 (5.01)	27.7 (5.08)
Week 6	24.2 (7.41)	22.7 (8.71)	21.9 (7.65)
Change From Baseline	-2.5 (6.73)	-5.3 (7.11)	-5.8 (6.67)

Placebo vs CG100649 2 mg: p = 0.011, ANCOVA
CG100649 2 mg vs Celecoxib 200 mg: p = 0.425, ANCOVA

Population analysed: Intent-to-Treat (ITT) population (Baseline Observation Carried Forward (BOCF))

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From ICF to Treatment Completion, up to 6 months (24weeks). Other adverse events reported at 2.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 71 (1.4%)	6 of 71 (8.5%)	Not reported
CG100649	2 of 146 (1.4%)	20 of 146 (13.7%)	Not reported
Celecoxib	1 of 145 (0.7%)	15 of 145 (10.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. This medication already got NDA approval in Korea

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.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 19 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 15 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 14 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 15 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 in WOMAC-Pain Subscale (time frame: Baseline, Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01765296.

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 15 Feb 2023.