PainPhase 4NCT00440739
Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy (TURP)
A Phase 4 study testing etoricoxib, flavoxate and etoricoxib, flavoxate in people with Pain, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether etoricoxib, flavoxate, both are effective in the treatment postoperative pain after TURP. The research hypothesis: There is a difference in postoperative morphine consumption in the first 24 hours after transurethral prostatectomy between patients who received… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pain
- What is being tested?
- etoricoxib, flavoxate and etoricoxib, flavoxate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2005to Dec 2007
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patient ASA physical status I-III.
- Scheduled for an elective TURP.
- Body weight > or = 50 kg
- Can operate a patient-controlled analgesia (PCA) device.
Who cannot join
- History of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs.
- Known hypersensitivity to morphine.
- History of hepatic dysfunction.
- Creatinine clearance < 30ml/min.
- History of bleeding tendency.
- History of gastrointestinal bleeding or active peptic ulcer.
Show all 9Show fewer
- Known case of inflammatory bowel disease.
- Patient with severe heart failure.
- History of coronary artery disease or cerebrovascular disease.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
About this study
Official title: Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy: A Factorial Randomized Controlled Trial
The purpose of this study is to determine whether etoricoxib, flavoxate, both are effective in the treatment postoperative pain after TURP.
The research hypothesis:
There is a difference in postoperative morphine consumption in the first 24 hours after transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and placebo.
Read the detailed description
Postoperative pain is still a significant problem for surgical patients. Conventional use of narcotics for postoperative pain relief is not without serious side effects such as respiratory depression and sedation.There are other alternatives for postoperative analgesia as NSAIDs especially COX2-inhibitors. For some specific operation such as TURP which Foley's catheter needed to be retained for a few days,urinary anti spasmodics may help the patients to be more comfortable.
Comparison(s): There is a difference in postoperative morphine consumption in the first 24 hours after transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and placebo.
- Conditions
- Pain
- Being tested
- etoricoxib, flavoxate, etoricoxib, flavoxate, placebo
- Keywords
- postoperative pain, etoticoxib, etoricoxib, Pain relief after transurethral resection of prostate.
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etoricoxibDrug
Also called arcoxia
etoricoxib 120 mg
flavoxateDrug
Also called urispas
flavoxate 200 mg 3 times
etoricoxib, flavoxateDrug
Also called arcoxia, urispas
etoricoxib 120 mg once and flavoxate 200 mg 3 times
placeboDrug
placebo once and placebo 3 times
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | 1=placebo Receives: Drug: placebo |
| 2 | Active comparator | 2= etoricoxib Receives: Drug: etoricoxib |
| 3 | Active comparator | 3=falvoxate Receives: Drug: flavoxate |
| 4 | Active comparator | etoricoxib and flavoxate Receives: Drug: etoricoxib, flavoxate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patients' total amount of morphine requirement in the first 24 hour.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startSep 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Sirilak Suksompong, MD, Principal investigator, Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440739
- Sponsor's protocol ID
- SiEc 161/2548
- Status last verified
- Feb 2007
- First submitted
- 2 Feb 2006
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy: A Factorial Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00440739
- Acronym / sponsor ID
- SiEc 161/2548
- Conditions
- Pain
- Keywords
- postoperative pain, etoticoxib, etoricoxib, Pain relief after transurethral resection of prostate.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Feb 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.
The purpose of this study is to determine whether etoricoxib, flavoxate, both are effective in the treatment postoperative pain after TURP.
The research hypothesis:
There is a difference in postoperative morphine consumption in the first 24 hours after transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and placebo.
Detailed description
Postoperative pain is still a significant problem for surgical patients. Conventional use of narcotics for postoperative pain relief is not without serious side effects such as respiratory depression and sedation.There are other alternatives for postoperative analgesia as NSAIDs especially COX2-inhibitors. For some specific operation such as TURP which Foley's catheter needed to be retained for a few days,urinary anti spasmodics may help the patients to be more comfortable.
Comparison(s): There is a difference in postoperative morphine consumption in the first 24 hours after transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placebo1=placebo |
| 2 | Active comparator | Drug: etoricoxib2= etoricoxib |
| 3 | Active comparator | Drug: flavoxate3=falvoxate |
| 4 | Active comparator | Drug: etoricoxib, flavoxateetoricoxib and flavoxate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patient ASA physical status I-III.
- Scheduled for an elective TURP.
- Body weight > or = 50 kg
- Can operate a patient-controlled analgesia (PCA) device.
Key exclusion criteria (9 listed)
- History of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs.
- Known hypersensitivity to morphine.
- History of hepatic dysfunction.
- Creatinine clearance < 30ml/min.
- History of bleeding tendency.
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 |
|---|---|---|
| etoricoxibAlso: arcoxiaetoricoxib 120 mg | Drug | 2 |
| flavoxateAlso: urispasflavoxate 200 mg 3 times | Drug | 3 |
| etoricoxib, flavoxateAlso: arcoxia, urispasetoricoxib 120 mg once and flavoxate 200 mg 3 times | Drug | 4 |
| placeboplacebo once and placebo 3 times | Drug | 1 |
Primary outcome
The patients' total amount of morphine requirement in the first 24 hour.
Time frame: 24 hour
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 5 Feb 2009.
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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.
Sirilak Suksompong, MD principal investigator
Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing etoricoxib, flavoxate and etoricoxib, flavoxate in people with Pain, run by Mahidol University at 1 site in Thailand.
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 9 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 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The patients' total amount of morphine requirement in the first 24 hour. (time frame: 24 hour). 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 5 Feb 2009.