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

Osteoarthritis Hand Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067194
• Other study ID #: 266HOA16008
• Status: Completed
• Phase: Phase 4
• Start date: December 27, 2016
• Est. completion date: November 20, 2018

Study information

• Verified date: November 2018
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: November 20, 2018
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Hand

Intervention

Drug:
• Celecoxib 100 MG
Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks
• Celecoxib 200mg
Celecoxib 200mg, Oral, QD(once daily), During 6 weeks

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety assessed by the incidence of adverse event		up to 6weeks
Other	laboratory test(Hematology test, Blood chemistry test, Urinalysis)		up to 6weeks
Primary	The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group		baseline, 6weeks
Secondary	Changes in each item of K-AUSCAN at 6 weeks relative to the baseline value of each group		baseline, 6weeks
Secondary	The total point change of K-AUSCAN at 6 weeks relative to the baseline value of each group		baseline, 6weeks
Secondary	Total score change of insomnia severity at 6 weeks relative to the baseline value of each group		baseline, 6weeks
Secondary	Total dosing days of acetaminophen for 6 weeks in each group		6weeks
Secondary	The total dose of acetaminophen for 6 weeks in each group		6weeks
Secondary	Percentage of subjects using acetaminophen for 6 weeks in each group		6weeks