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

NCT00440739 | Completed Phase 4

• 1 other identifier: SiEc 161/2548
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  24 hour

Study Arms (4)

1

PLACEBO COMPARATOR

1=placebo

Drug: placebo

2

ACTIVE COMPARATOR

2= etoricoxib

Drug: etoricoxib

3

ACTIVE COMPARATOR

3=falvoxate

Drug: flavoxate

4

ACTIVE COMPARATOR

etoricoxib and flavoxate

Drug: etoricoxib, flavoxate

Interventions

etoricoxib DRUG

etoricoxib 120 mg

Also known as: arcoxia

2

flavoxate DRUG

flavoxate 200 mg 3 times

Also known as: urispas

3

etoricoxib, flavoxate DRUG

etoricoxib 120 mg once and flavoxate 200 mg 3 times

Also known as: arcoxia, urispas

4

placebo DRUG

placebo once and placebo 3 times

1

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Known case of inflammatory bowel disease.
• Patient with severe heart failure.
• History of coronary artery disease or cerebrovascular disease.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Etoricoxib; Flavoxate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sirilak Suksompong, MD

  Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 2, 2006
• First Posted: February 27, 2007
• Study Start: September 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 5, 2009

Record last verified: 2007-02

Locations

TH (1)