Efficacy of Celecoxib vs Placebo to Prevent Pain in a Pac... | NCT00194090

Studies
Efficacy of Celecoxib vs Placebo to Prevent Pain in a Paced Walk

NCT00194090

Sponsor

University Hospitals Cleveland Medical Center

Status

Completed

Last Update Posted

Aug 26, 2022Actual

Enrollment

40Actual

Phase

Phase 4

Conditions

Knee Osteoarthritis

Interventions

celecoxib

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004Actual

Primary Completion Date

Sep 1, 2005Actual

Completion Date

Sep 1, 2005Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2022

Last Update Posted Date

Aug 26, 2022Actual

Name	Class
Pfizer	INDUSTRY

Description Module

Brief Summary

A paced 20-minute walk is a reproducible model for acute pain in knee osteoarthritis

Detailed Description

This is a randomizd, placbo-controlled, crossover trial comparing a single dose of celecoxib to placebo measuring the time to onset of acute pain in a paced 20-minute walk.

40 subjects will be enrolled

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Name	Type	Description	Arm Group Labels	Other Names
celecoxib	Drug

Measure	Description	Time Frame
time to onset of severe pain

Measure	Description	Time Frame
time to onset of moderate pain

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Knee osteoarthritis by ACR clinical criteria Pain of at least 40 mm by VAS at baseline

Exclusion Criteria:

Non-pregant, non-lactating Able to stop active arthritis medication for washout Cardiovascular risk factors Abnormal EKG -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michele M Hooper, MD, MS	University Hospitals Cleveland Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals of Cleveland		Cleveland	Ohio	44106	United States

Label	URL
hospital site to inquire about clinical trials	View source

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D010146	Pain
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068579	Celecoxib

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided