CLINICAL PROTOCOL FOR A MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF A SINGLE DOSAGE OF PARODOXIB SODIUM IV VS. A SINGLE DOSE OF KETOPROPHENE IV VS. ONE UNIQUE DOSAGE OF KETOROLACO IV VS. PLACEBO FOR THE TREATMENT OF PAIN AFTER A LAPAROSCOPIC COLLECISECTOMY.

Not Applicable

• Conditions: -K819 Cholecystitis, unspecified; Cholecystitis, unspecified; K819

• Registration Number: PER-077-02
• Lead Sponsor: PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-12-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.- Men or women between 18 and 75 years of age.
2.- The patient has a body weight of 50 to 120 kg
3.- The patient requires an elective laparoscopic cholecystectomy.
4.- A procedure is anticipated under an ambulatory patient scheme.

Exclusion Criteria

The patient is scheduled to undergo some other surgical procedure that is expected to produce a greater degree of surgical traction than laparoscopic cholecystectomy alone.
Acute preoperative pain other than biliary colic.
A condition of chronic pain that requires chronic treatment and / or which, in the opinion of the Investigator, may affect pain assessments or the response to therapy.
The patient has any type of cognitive impairment that, in the opinion of the Investigator, would impede participation in the study or adherence to the procedures required in the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified