Clinical trial NCT03067194: The Study to Evaluate Efficacy and Safety of Celecoxib Capsule in Hand Osteoarthritis Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis Hand
Keywords: Osteoarthritis Hand
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2017-03-01
Enrollment: 117
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group
timeFrame: baseline, 6weeks
Secondary outcomes:
measure: Changes in each item of K-AUSCAN at 6 weeks relative to the baseline value of each group
timeFrame: baseline, 6weeks
measure: The total point change of K-AUSCAN at 6 weeks relative to the baseline value of each group
timeFrame: baseline, 6weeks
measure: Total score change of insomnia severity at 6 weeks relative to the baseline value of each group
timeFrame: baseline, 6weeks
measure: Total dosing days of acetaminophen for 6 weeks in each group
timeFrame: 6weeks
measure: The total dose of acetaminophen for 6 weeks in each group
timeFrame: 6weeks
measure: Percentage of subjects using acetaminophen for 6 weeks in each group
timeFrame: 6weeks
Other outcomes:
measure: Safety assessed by the incidence of adverse event
timeFrame: up to 6weeks
measure: laboratory test(Hematology test, Blood chemistry test, Urinalysis)
timeFrame: up to 6weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital
Study officials:
affiliation: Soonchunhyang University Hospital
name: Hyun Sook Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Soonchunhyang University Hospital
name: Chan Hong Jeon
role: PRINCIPAL_INVESTIGATOR
affiliation: Soonchunhyang University Hospital
name: Sung Hae Jang
role: PRINCIPAL_INVESTIGATOR
References: