Antiphospholipid Antibody SyndromeCI(R)CANCT01762891
CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen
A study testing Celecoxib, Acetaminophen and Rofecoxib in people with Antiphospholipid Antibody Syndrome, run by Hospital Universitario Pedro Ernesto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Antiphospholipid Antibody Syndrome
- What is being tested?
- Celecoxib, Acetaminophen and Rofecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PAPS on contious stable dose of coumadin
- 18 years old or older
- Younger than 65 yo
- Signed informed consent.
Who cannot join
- Renal failure
- Heart failure
- Symptomatic gastritis or peptic ulcer
- Elevated liver enzymes (>3 fold)
- Platelet count < 100,000.
About this study
Official title: CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen. A Prospective Double-blind, Placebo Controlled Study.
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.
Read the detailed description
The CI(R)CA study included patient diagnosed with antiphospholipid syndrome in permanent use of coumadin. Eligible patients were invited to use in a prospective cross-over mode two weeks of celecoxib, rofecoxib, acetaminophen and placebo with two weeks of wash out between drugs. Their international normalized ratio (INR) were measured before and during the use of each study drug. The interaction with coumadin was evaluated according to increases or decreases on the INR after each medication.
- Conditions
- Antiphospholipid Antibody Syndrome
- Being tested
- Celecoxib, Acetaminophen, Rofecoxib, placebo
- Keywords
- Coumadin, celecoxib, rofecoxib, acetaminophen, antiphospholipid syndrome and INR
- Medical subject headings
- Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called celebrex
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.
AcetaminophenDrug
Also called Tylenol
Acetaminophen 3g/ was given during 15 days by oral rout following one of the other interventions or as the final intervention.
RofecoxibDrug
Also called Vioxx
Rofecoxib 25mg/day was given by oral rout during 15 days following one or more interventions or as the final intervention.
placeboDrug
Placebo pills were given during 15 days by oral rout as one of the four interventions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Celecoxib; Drug: Acetaminophen; Drug: Rofecoxib; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Normalized Ratio
The outcome measure was verified 15 days after each intervention.
Measured: increase or decrease on the INR after coxibs or placebo use during 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startMar 2003
- Primary completionJul 2006
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid Antibody SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Pedro Ernesto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veronica Silva Vilela, Hospital Universitario Pedro Ernesto
- Investigators
- Veronica S Vilela, MD, Principal investigator, Hospital Universitario Pedro Ernesto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762891
- Sponsor's protocol ID
- 32323232
- Other IDs
- Pfizer
- Acronym
- CI(R)CA
- Status last verified
- Jan 2013
- First submitted
- 24 Sep 2009
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen. A Prospective Double-blind, Placebo Controlled Study.
- ClinicalTrials.gov ID
- NCT01762891
- Acronym / sponsor ID
- CI(R)CA / 32323232
- Conditions
- Antiphospholipid Antibody Syndrome
- Keywords
- Coumadin, celecoxib, rofecoxib, acetaminophen, antiphospholipid syndrome and INR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hospital Universitario Pedro ErnestoUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Jul 2006 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 8 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The CI(R)CA study included patient diagnosed with antiphospholipid syndrome in permanent use of coumadin. Eligible patients were invited to use in a prospective cross-over mode two weeks of celecoxib, rofecoxib, acetaminophen and placebo with two weeks of wash out between drugs. Their international normalized ratio (INR) were measured before and during the use of each study drug. The interaction with coumadin was evaluated according to increases or decreases on the INR after each medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celecoxib | Experimental | Drug: Celecoxib, Drug: Acetaminophen, Drug: Rofecoxib, Drug: placeboCelecoxib 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PAPS on contious stable dose of coumadin
- 18 years old or older
- Younger than 65 yo
- Signed informed consent.
Key exclusion criteria (5 listed)
- Renal failure
- Heart failure
- Symptomatic gastritis or peptic ulcer
- Elevated liver enzymes (>3 fold)
- Platelet count < 100,000.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelecoxibAlso: celebrexcelecoxib 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. | Drug | Celecoxib |
| AcetaminophenAlso: TylenolAcetaminophen 3g/ was given during 15 days by oral rout following one of the other interventions or as the final intervention. | Drug | Celecoxib |
| RofecoxibAlso: VioxxRofecoxib 25mg/day was given by oral rout during 15 days following one or more interventions or as the final intervention. | Drug | Celecoxib |
| placeboPlacebo pills were given during 15 days by oral rout as one of the four interventions. | Drug | Celecoxib |
Primary outcome
International Normalized Ratio
Time frame: increase or decrease on the INR after coxibs or placebo use during 15 days
The outcome measure was verified 15 days after each intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica S Vilela, MD principal investigator
Hospital Universitario Pedro Ernesto
Questions about this trial
What is this clinical trial studying?
A study testing Celecoxib, Acetaminophen and Rofecoxib in people with Antiphospholipid Antibody Syndrome, run by Hospital Universitario Pedro Ernesto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Normalized Ratio (time frame: increase or decrease on the INR after coxibs or placebo use during 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2013.