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CompletedNCT00440739Updated Feb 5, 2009

Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy (TURP)

A Phase 4 interventional study of etoricoxib and flavoxate in Pain, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-02-05.

Sponsored by Mahidol University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Pain

Keywords

  • postoperative pain, etoticoxib, etoricoxib
  • Pain relief after transurethral resection of prostate.
03

In context

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. Male patient ASA physical status I-III.
  2. Scheduled for an elective TURP.
  3. Body weight > or = 50 kg
  4. Can operate a patient-controlled analgesia (PCA) device.

Exclusion criteria

Exclusion Criteria:

  1. History of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs.
  2. Known hypersensitivity to morphine.
  3. History of hepatic dysfunction.
  4. Creatinine clearance \< 30ml/min.
  5. History of bleeding tendency.
  6. History of gastrointestinal bleeding or active peptic ulcer.
  7. Known case of inflammatory bowel disease.
  8. Patient with severe heart failure.
  9. History of coronary artery disease or cerebrovascular disease.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
128 participants (actual)

Study arms

  • Placebo comparator
    1

    1=placebo

    Drug: placebo

  • Active comparator
    2

    2= etoricoxib

    Drug: etoricoxib

  • Active comparator
    3

    3=falvoxate

    Drug: flavoxate

  • Active comparator
    4

    etoricoxib and flavoxate

    Drug: etoricoxib, flavoxate

Interventions

  • Drugetoricoxib

    etoricoxib 120 mg

    Also known as: arcoxia

  • Drugflavoxate

    flavoxate 200 mg 3 times

    Also known as: urispas

  • Drugetoricoxib, flavoxate

    etoricoxib 120 mg once and flavoxate 200 mg 3 times

    Also known as: arcoxia, urispas

  • Drugplacebo

    placebo once and placebo 3 times

06

What researchers measure

Primary outcomes

  1. The patients' total amount of morphine requirement in the first 24 hour.

    Time frame: 24 hour

07

Study locations

1 site
  • Faculty of Medicine Siriraj Hospital, Mahidol University
    Bangkok, 10700, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00440739
Lead sponsor
Mahidol University
First posted
Feb 27, 2007
Start date
Sep 2005
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Feb 5, 2009

Study contacts

Sirilak Suksompong, MD
principal investigator · Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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