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The purpose of this study is to evaluate efficacy and safety of Celecoxib capsule in hand osteoarthritis patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib 100mg | Active Comparator | Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks |
|
| Celecoxib 200mg | Active Comparator | Celecoxib 200mg, Oral, QD(once daily), During 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib 100 MG | Drug | Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group | baseline, 6weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in each item of K-AUSCAN at 6 weeks relative to the baseline value of each group | baseline, 6weeks | |
| The total point change of K-AUSCAN at 6 weeks relative to the baseline value of each group | baseline, 6weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by the incidence of adverse event | up to 6weeks | |
| laboratory test(Hematology test, Blood chemistry test, Urinalysis) | up to 6weeks |
Inclusion Criteria:
Exclusion Criteria:
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
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Hyun Sook Kim | Soonchunhyang University Hospital | Principal Investigator |
| Chan Hong Jeon | Soonchunhyang University Hospital | Principal Investigator |
| Sung Hae Jang | Soonchunhyang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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Assignment
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| Celecoxib 200mg | Drug | Celecoxib 200mg, Oral, QD(once daily), During 6 weeks |
|
|
| Total score change of insomnia severity at 6 weeks relative to the baseline value of each group | baseline, 6weeks |
| Total dosing days of acetaminophen for 6 weeks in each group | 6weeks |
| The total dose of acetaminophen for 6 weeks in each group | 6weeks |
| Percentage of subjects using acetaminophen for 6 weeks in each group | 6weeks |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |