NCT03067194

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 27, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2018

Completed
Last Updated

January 30, 2020

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

February 3, 2017

Last Update Submit

January 28, 2020

Conditions

Osteoarthritis Hand

Keywords

Osteoarthritis Hand

Outcome Measures

Primary Outcomes (1)

  • The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group

    baseline, 6weeks

Secondary Outcomes (6)

  • 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

  • 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

  • +1 more secondary outcomes

Other Outcomes (2)

  • Safety assessed by the incidence of adverse event

    up to 6weeks

  • laboratory test(Hematology test, Blood chemistry test, Urinalysis)

    up to 6weeks

Study Arms (2)

Celecoxib 100mg

ACTIVE COMPARATOR

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

Drug: Celecoxib 100 MG

Celecoxib 200mg

ACTIVE COMPARATOR

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

Drug: Celecoxib 200mg

Interventions

Celecoxib 100 MGDRUG

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

Also known as: Celecoxib 100mg capsule
Celecoxib 100mg
Celecoxib 200mgDRUG

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

Also known as: Celecoxib 200mg capsule
Celecoxib 200mg

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soon Chun Hyang University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hyun Sook Kim

    Soonchunhyang University Hospital

    PRINCIPAL INVESTIGATOR

  • Chan Hong Jeon

    Soonchunhyang University Hospital

    PRINCIPAL INVESTIGATOR

  • Sung Hae Jang

    Soonchunhyang University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2017

First Posted

March 1, 2017

Study Start

December 27, 2016

Primary Completion

July 10, 2017

Study Completion

November 20, 2018

Last Updated

January 30, 2020

Record last verified: 2018-11

Locations

KR(1)