Official Title: “A Multicenter, Open Label Trial To Evaluate Analgesic Effect Of Intravenous And Subsequent Oral Therapy With Parecoxib/Valdecoxib (Bextra® IM/IV And Bextra®) 40 Mg/Day For Treatment Of Post-Laparoscopic Surgery Pain”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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.

Primary:

• Visual Analog Scale Pain Intensity (0-100 mm), which was evaluated using the change from baseline Day 3 No

Secondary:

• Visual Analog Scale Pain Intensity Day 7 No
• Categorical Pain Intensity Day 3 and Day 7 No
• Patient pain relief Day 3 and Day 7 No
• Composite Upper Gastrointestinal (UGI) Tolerability measure was calculated; an UGI event was considered if the patient reported at least one of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe Study endpoint Yes
• Dyspepsia Study endpoint Yes
• Adverse events Day 1, Day 3, and Day 7 Yes
• Patient Global Evaluation Day 3 and Day 7 No

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

Lead Sponsor: Pfizer

Pfizer Investigational Site

Buenos Aires  C1280AEB Argentina

Pfizer Investigational Site

Buenos Aires  C1230AAW Argentina

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00660855

Study ID Number: A3471107

ClinicalTrials.gov Identifier: NCT00660855

Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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