A Multicenter, Open Label Trial To Evaluate Pain Relief With Intravenous Followed By Oral Therapy With Parecoxib/Valdecoxib 40 Mg/Day For Treatment Of Post-Laparoscopic Surgery Pain

Pfizer

Status and phase: Terminated; Phase 4

Conditions: Pain, Post Surgical

Treatments: Drug: parecoxib/valdecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00660855

A3471107

Details and patient eligibility

About

The objectives of this study were to assess the analgesic efficacy and safety of parecoxib/valdecoxib on post-laparoscopic surgery analgesia.

Full description

This study A3471107 was terminated on February 4th, 2005 due to enrollment difficulties, problems related to need for rescue medication, and perceptions about cardiovascular risk potentially associated with all NSAIDs.

Enrollment: 4 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who had undergone laparoscopic surgery
• Patients in need of post-surgical analgesia

Exclusion criteria

• Patients with an unexpected surgical complication which, in the Investigator's opinion, placed the patient at significantly higher risk for post-surgical complication(s), or for non-routine post-operative care requirements
• Patients who took any nonsteroidal anti-inflammatory drug or any analgesic within 48 hours prior to surgery

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Arm 1

Other group

Treatment:

Drug: parecoxib/valdecoxib