Laparoscopic Surgery for AppendicitisPhase 4NCT00565682
Pain Post Abdominal Laparoscopy Prevention With Arcoxia
A Phase 4 study testing etoricoxib 120 mg in people with Laparoscopic Surgery for Appendicitis and Laparoscopic Surgery for Cholecystitis, run by Hospital Vozandez.
Trial summary
To test the analgesic efficacy of etoricoxib used before a surgical procedure compared to the already known effect when administered after such a procedure. Patient will be receiving either etoricoxib or the respective placebo one hour before surgery, then two hours after those receiving the active will receive… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laparoscopic Surgery for Appendicitis, Laparoscopic Surgery for Cholecystitis, Laparoscopic Surgery for Ovarian Cysts
- What is being tested?
- etoricoxib 120 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Dec 2006
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary acceptance to participate in the study and signed the informed consent form
- Age older than 18 years old and younger than 70 years
- Diagnosis of appendicitis, cholecystitis or ovarian cysts suitable of laparoscopic surgery
Who cannot join
- Age less than 18 years or older than 70 years.
- Laparoscopic procedures for diagnostic purposes.
- Current use of anticoagulants.
- Known hypersensitivity to etoricoxib or its components.
- History of a CABG or MI (less than 1 year)
- History of unstable angina (over the past six months).
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- Current inflammatory bowel disease.
- Uncontrolled hypertension or heart failure
- Renal dysfunction/impairment (creatinine clearance < 30ml/min)
- Cirrhosis or severe hepatic dysfunction
- Any degree of dehydration (mild to severe)
About this study
To test the analgesic efficacy of etoricoxib used before a surgical procedure compared to the already known effect when administered after such a procedure. Patient will be receiving either etoricoxib or the respective placebo one hour before surgery, then two hours after those receiving the active will receive placebo and those that received placebo will be given etoricoxib. Pain score measurements will be performed sequentially. Rescue medication will be available all the time.
- Conditions
- Laparoscopic Surgery for Appendicitis, Laparoscopic Surgery for Cholecystitis, Laparoscopic Surgery for Ovarian Cysts
- Being tested
- etoricoxib 120 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etoricoxib 120 mgDrug
Also called Arcoxia
etoricoxib 120 mg, tablet, orally, OD
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Etoricoxib 120 mg Receives: Drug: etoricoxib 120 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the amount of rescue medication (opioid) needed to relief
Measured: Every hour after surgery
Secondary outcomes (1)
To determine the overall analgesic effect using the visual analog scale (VAS)
Measured: Every hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startApr 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Surgery for AppendicitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Vozandez
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Eduardo Noboa, MD, Principal investigator, Hospital Vozandez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565682
- Sponsor's protocol ID
- DOLAAR
- Status last verified
- Nov 2007
- First submitted
- 29 Nov 2007
- Last updated
- 30 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Post Abdominal Laparoscopy Prevention With Arcoxia
- ClinicalTrials.gov ID
- NCT00565682
- Acronym / sponsor ID
- DOLAAR
- Conditions
- Laparoscopic Surgery for Appendicitis, Laparoscopic Surgery for Cholecystitis, Laparoscopic Surgery for Ovarian Cysts
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital VozandezUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 30 Nov 2007 (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.
To test the analgesic efficacy of etoricoxib used before a surgical procedure compared to the already known effect when administered after such a procedure. Patient will be receiving either etoricoxib or the respective placebo one hour before surgery, then two hours after those receiving the active will receive placebo and those that received placebo will be given etoricoxib. Pain score measurements will be performed sequentially. Rescue medication will be available all the time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: etoricoxib 120 mgEtoricoxib 120 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Voluntary acceptance to participate in the study and signed the informed consent form
- Age older than 18 years old and younger than 70 years
- Diagnosis of appendicitis, cholecystitis or ovarian cysts suitable of laparoscopic surgery
Key exclusion criteria (11 listed)
- Age less than 18 years or older than 70 years.
- Laparoscopic procedures for diagnostic purposes.
- Current use of anticoagulants.
- Known hypersensitivity to etoricoxib or its components.
- History of a CABG or MI (less than 1 year)
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 |
|---|---|---|
| etoricoxib 120 mgAlso: Arcoxiaetoricoxib 120 mg, tablet, orally, OD | Drug | A |
Primary outcome
To measure the amount of rescue medication (opioid) needed to relief
Time frame: Every hour after surgery
1 secondary outcome
To determine the overall analgesic effect using the visual analog scale (VAS)
Time frame: Every hour after surgery
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 30 Nov 2007.
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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.
Eduardo Noboa, MD principal investigator
Hospital Vozandez
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing etoricoxib 120 mg in people with Laparoscopic Surgery for Appendicitis and Laparoscopic Surgery for Cholecystitis, run by Hospital Vozandez.
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 3 inclusion and 11 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 30 Nov 2007. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To measure the amount of rescue medication (opioid) needed to relief (time frame: Every hour after surgery). 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 30 Nov 2007.