Osteoarthritis HandPhase 4NCT03067194
The Study to Evaluate Efficacy and Safety of Celecoxib Capsule in Hand Osteoarthritis Patients
A Phase 4 study testing Celecoxib 100 MG and Celecoxib 200mg in people with Osteoarthritis Hand, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate efficacy and safety of Celecoxib capsule in hand osteoarthritis patients. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis Hand
- What is being tested?
- Celecoxib 100 MG and Celecoxib 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Dec 2016to 20 Nov 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agreement with written informed consent and 19 years of age and older
- Patients history of OA of hand according to ACR criteria
- The 100mm Pain VAS is over 40mm
Who cannot join
- History of OA of hand surgery
- Intra-articular injections within 3 months
- History of OA of hand infections within 3 months
- Who had taken a drug that has a control of result in clinical trial by investigator's decision
- Pregnant women, nursing mothers or Fertile women who not practice contraception with appropriate methods
- clinically significant hepatic, renal, cardiovascular diseases
Show all 17Show fewer
- Any history of adverse reaction to the study drugs
- Patients with gastrointestinal ulcers or bleeding disorders
- Finger joint injury within 6 months
- Who had following results after examination
- K ≥ 5.5mEq/L
- eGFR ≤ 30ml/min/1.73m^2
- Patients on any other clinical trial or experimental treatment in the past 3 months
- Taking narcotic analgesics or patches
- History of drug abuse or alcoholism
- Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders
- An impossible one who participates in clinical trial by investigator's decision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Celecoxib 200mg Capsule QD and Celecoxib 100mg BID in Hand Osteoarthritis Patients
The purpose of this study is to evaluate efficacy and safety of Celecoxib capsule in hand osteoarthritis patients.
Read the detailed description
This is a six-weeks, open-label, multi-center, randomized study. Patients take Celecoxib 200mg capsule once a day or Celecoxib 100mg capsules twice per day. If patients do not tolerate the pain, they are able to take Acetaminophen as a rescue medication during 6 weeks.
- Conditions
- Osteoarthritis Hand
- Being tested
- Celecoxib 100 MG, Celecoxib 200mg
- Keywords
- Osteoarthritis Hand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celecoxib 100 MGDrug
Also called Celecoxib 100mg capsule
Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks
Celecoxib 200mgDrug
Also called Celecoxib 200mg capsule
Celecoxib 200mg, Oral, QD(once daily), During 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib 100mg | Active comparator | Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks Receives: Drug: Celecoxib 100 MG |
| Celecoxib 200mg | Active comparator | Celecoxib 200mg, Oral, QD(once daily), During 6 weeks Receives: Drug: Celecoxib 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group
Measured: baseline, 6weeks
Secondary outcomes (6)
Changes in each item of K-AUSCAN at 6 weeks relative to the baseline value of each group
Measured: baseline, 6weeks
The total point change of K-AUSCAN at 6 weeks relative to the baseline value of each group
Measured: baseline, 6weeks
Total score change of insomnia severity at 6 weeks relative to the baseline value of each group
Measured: baseline, 6weeks
Total dosing days of acetaminophen for 6 weeks in each group
Measured: 6weeks
The total dose of acetaminophen for 6 weeks in each group
Measured: 6weeks
Percentage of subjects using acetaminophen for 6 weeks in each group
Measured: 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start27 Dec 2016
- Primary completion10 Jul 2017
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis HandStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyun Sook Kim, Principal investigator, Soonchunhyang University HospitalChan Hong Jeon, Principal investigator, Soonchunhyang University HospitalSung Hae Jang, Principal investigator, Soonchunhyang University Cheonan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067194
- Sponsor's protocol ID
- 266HOA16008
- Status last verified
- Nov 2018
- First submitted
- 3 Feb 2017
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Celecoxib 200mg Capsule QD and Celecoxib 100mg BID in Hand Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT03067194
- Acronym / sponsor ID
- 266HOA16008
- Conditions
- Osteoarthritis Hand
- Keywords
- Osteoarthritis Hand
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2016 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate efficacy and safety of Celecoxib capsule in hand osteoarthritis patients.
Detailed description
This is a six-weeks, open-label, multi-center, randomized study. Patients take Celecoxib 200mg capsule once a day or Celecoxib 100mg capsules twice per day. If patients do not tolerate the pain, they are able to take Acetaminophen as a rescue medication during 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Celecoxib 100mg | Active comparator | Drug: Celecoxib 100 MGCelecoxib 100mg, Oral, BID(twice per day), During 6 weeks |
| Celecoxib 200mg | Active comparator | Drug: Celecoxib 200mgCelecoxib 200mg, Oral, QD(once daily), During 6 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Agreement with written informed consent and 19 years of age and older
- Patients history of OA of hand according to ACR criteria
- The 100mm Pain VAS is over 40mm
Key exclusion criteria (17 listed)
- History of OA of hand surgery
- Intra-articular injections within 3 months
- History of OA of hand infections within 3 months
- Who had taken a drug that has a control of result in clinical trial by investigator's decision
- Pregnant women, nursing mothers or Fertile women who not practice contraception with appropriate methods
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 |
|---|---|---|
| Celecoxib 100 MGAlso: Celecoxib 100mg capsuleCelecoxib 100mg, Oral, BID(twice per day), During 6 weeks | Drug | Celecoxib 100mg |
| Celecoxib 200mgAlso: Celecoxib 200mg capsuleCelecoxib 200mg, Oral, QD(once daily), During 6 weeks | Drug | Celecoxib 200mg |
Primary outcome
The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group
Time frame: baseline, 6weeks
6 secondary outcomes
Changes in each item of K-AUSCAN at 6 weeks relative to the baseline value of each group
Time frame: baseline, 6weeks
The total point change of K-AUSCAN at 6 weeks relative to the baseline value of each group
Time frame: baseline, 6weeks
Total score change of insomnia severity at 6 weeks relative to the baseline value of each group
Time frame: baseline, 6weeks
Total dosing days of acetaminophen for 6 weeks in each group
Time frame: 6weeks
The total dose of acetaminophen for 6 weeks in each group
Time frame: 6weeks
Percentage of subjects using acetaminophen for 6 weeks in each group
Time frame: 6weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- 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.
Hyun Sook Kim principal investigator
Soonchunhyang University Hospital
Chan Hong Jeon principal investigator
Soonchunhyang University Hospital
Sung Hae Jang principal investigator
Soonchunhyang University Cheonan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Celecoxib 100 MG and Celecoxib 200mg in people with Osteoarthritis Hand, run by Chong Kun Dang Pharmaceutical 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 3 inclusion and 17 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 30 Jan 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group (time frame: baseline, 6weeks). 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 30 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.