The Study to Evaluate Efficacy and Safety of Celecoxib Capsule in Hand Osteoarthritis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-27

Study Completion Date

2018-11-20

Brief Summary

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The purpose of this study is to evaluate efficacy and safety of Celecoxib capsule in hand osteoarthritis patients.

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Detailed Description

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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

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Osteoarthritis Hand

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Celecoxib 100mg

Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks

Group Type ACTIVE_COMPARATOR

Celecoxib 100 MG

Intervention Type DRUG

Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks

Celecoxib 200mg

Celecoxib 200mg, Oral, QD(once daily), During 6 weeks

Group Type ACTIVE_COMPARATOR

Celecoxib 200mg

Intervention Type DRUG

Celecoxib 200mg, Oral, QD(once daily), During 6 weeks

Interventions

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Celecoxib 100 MG

Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks

Intervention Type DRUG

Celecoxib 200mg

Celecoxib 200mg, Oral, QD(once daily), During 6 weeks

Intervention Type DRUG

Other Intervention Names

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Celecoxib 100mg capsule Celecoxib 200mg capsule

Eligibility Criteria

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Inclusion Criteria

* 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

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

1. K ≥ 5.5mEq/L
2. 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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes