CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen

NCT01762891 | Completed

• 2 other identifiers: 32323232Pfizer
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

Coumadin drug-drug interactions (DDI) are frequent. Patients in permanent use of coumadin are advised to avoid traditional nonsteroidal antiinflammatory drugs to avoid risk of bleeding. New selctive cyclooxygesase 2 inhibitors arisen as potential option for treating pain and inflamation in these patients once interactions with coumadin are supposed to be lower. The CI(R)CA study was made to evaluate in a prospective fashion the occurrence of DDI with new cyclooxygenase antiinflammatory drugs and coumadin when compared to acetaminophen and placebo.

Conditions

Antiphospholipid Antibody Syndrome

Keywords

Coumadin; celecoxib; rofecoxib; acetaminophen; antiphospholipid syndrome and INR

Outcome Measures

Primary Outcomes (1)

• International Normalized Ratio

  The outcome measure was verified 15 days after each intervention.

  increase or decrease on the INR after coxibs or placebo use during 15 days

Study Arms (1)

Celecoxib

EXPERIMENTAL

Celecoxib 200mg/day oral rout Intervention: celecoxib 200mg oral rout administered durng 15 days and followed by administration of rofecoxib 25mg/day during 15 days, placebo 15 days and acetaminophen 3g/day during 15 days.

Drug: Celecoxib; Drug: Acetaminophen; Drug: Rofecoxib; Drug: placebo

Interventions

Celecoxib DRUG

celecoxib 200mg/day by oral rout during 15 days followed by the administration of rofecoxib 25mg/day, acetaminophen 3g/day and placebo during 15 days each drug.

Also known as: celebrex

Celecoxib

Acetaminophen DRUG

Acetaminophen 3g/ was given during 15 days by oral rout following one of the other interventions or as the final intervention.

Also known as: Tylenol

Celecoxib

Rofecoxib DRUG

Rofecoxib 25mg/day was given by oral rout during 15 days following one or more interventions or as the final intervention.

Also known as: Vioxx

Celecoxib

placebo DRUG

Placebo pills were given during 15 days by oral rout as one of the four interventions.

Celecoxib

Eligibility Criteria

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

You may qualify if:

• PAPS on contious stable dose of coumadin
• years old or older
• Younger than 65 yo
• Signed informed consent.

You may not qualify if:

• Renal failure
• Heart failure
• Symptomatic gastritis or peptic ulcer
• Elevated liver enzymes (\>3 fold)
• Platelet count \< 100,000.

Sponsors & Collaborators

• Hospital Universitario Pedro Ernesto: lead

MeSH Terms

Conditions

Antiphospholipid Syndrome

Interventions

Celecoxib; Acetaminophen; rofecoxib

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

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; Acetanilides; Anilides; Aniline Compounds; Amines

Study Officials

• Veronica S Vilela, MD

  Hospital Universitario Pedro Ernesto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: January 8, 2013
• Study Start: March 1, 2003
• Primary Completion: July 1, 2006
• Study Completion: September 1, 2009
• Last Updated: January 8, 2013

Record last verified: 2013-01