Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain

NCT00446797 | Completed Phase 4 Results

• 1 other identifier: A3191332
• Study Type: interventional
• Target: 278
• Locations: 8 countries
• Sites: 16

Brief Summary

To assess the efficacy of celecoxib loading dose of 400mg followed by 200 mg twice a day (BID) versus oral non-selective NSAIDs in acute pain due to ankle sprain.

Conditions

Ankle Sprain

Keywords

Ankle sprain, acute pain, NSAID, celecoxib,

Outcome Measures

Primary Outcomes (1)

• Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population

  Assessment of ankle pain by VAS: 100 mm horizontal line with left end being "No Pain" \& right end being "Worst Possible Pain". Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at day 3 minus mean score at baseline

  Baseline and day 3

Secondary Outcomes (19)

• Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population

  Baseline and days 2, 3 and 7

• Number of Subjects Responding (Improving) - MITT Population

  Days 2, 3 and 7

• Subject's Global Assessment of Ankle Injury

  Days 2, 3 and 7

• Physician Global Assessment of Ankle Injury

  Days 3 and 7

• Pain Relief - MITT Population

  Days 2, 3 and 7

Study Arms (2)

Non-Selective NSAIDS

ACTIVE COMPARATOR

nsNSAIDs used in real-life standard practice for treatment of pain due to ankle sprain.

Drug: Non-selective NSAIDS

Celecoxib

EXPERIMENTAL

Drug: Celecoxib

Interventions

Non-selective NSAIDS DRUG

Non-selective NSAIDs administered at usual (standard) doses.

Non-Selective NSAIDS

Celecoxib DRUG

celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.

Celecoxib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with first acute ankle sprain episode in the last six months classified as grade I or II, confirmed by X-rays, according to the following definitions:
• Grade I: When the ligament is stretched but not torn and the anterior talofibular ligament is usually involved. The anterior draw test is negative.
• Grade II: Moderate sprains which usually result in partial tears af the ligaments, primarily the anterior talofibular and possibly the calcaneofibular ligament. Ligamentous laxity may be present and there is moderate swelling.

You may not qualify if:

• Patients who have a similar injury of the same joint within the last six months; or
• clinical evidence of complete rupture of ankle ligaments (third degree sprain), or
• requirements for bed rest, hospitalization, surgical intervention for the ankle injury; or
• evidence of fractures; or non-removable full cast of any tipe; or
• presence of bilateral occurrence of ankle injury or ipsilateral ankle and knee injury.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (16)

Pfizer Investigational Site

Goiânia, Goiás, 74075-020, Brazil

Location

Pfizer Investigational Site

Rio de Janeiro, Rio de Janeiro, 20221-161, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 01221-900, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 02720-000, Brazil

Location

Pfizer Investigational Site

San Antonio Guadalupe, Guadalupe, San Jose, Costa Rica

Location

Pfizer Investigational Site

Quito, Pichincha, Ecuador

Location

Pfizer Investigational Site

Cairo, Egypt

Location

Pfizer Investigational Site

Amman, 11181 Jordan, Jordan

Location

Pfizer Investigational Site

Amman, 11193 Jordan, Jordan

Location

Pfizer Investigational Site

Amman, 22110 Jordan, Jordan

Location

Pfizer Investigational Site

Mexico City, Mexico City, 10700, Mexico

Location

Pfizer Investigational Site

San Nicolás de los Garza, Nuevo León, 66451, Mexico

Location

Pfizer Investigational Site

Toluca, State of Mexico, 50180, Mexico

Location

Pfizer Investigational Site

México DF, 03020, Mexico

Location

Pfizer Investigational Site

Panama City, Panama

Location

Pfizer Investigational Site

Lima, L27, Peru

Location

Related Publications (1)

• Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.

  PMID: 32797734 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Ankle Injuries; Acute Pain

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2007
• First Posted: March 13, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: February 21, 2021
• Results First Posted: June 10, 2009

Record last verified: 2021-02

Locations

BR (4); CO (1); PE (1); PA (1); EC (1); EG (1); JO (3); ME (4)