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.

Intervention(s) in this Clinical Trial

• Drug: parecoxib/valdecoxib
  • parecoxib 40 mg intravenously after recovery from anesthesia; if pain persisted, the patient could receive an optional second drug dose on Study Day 1 (only) if more than 4 hours after the first dose. When the patient was able to tolerate oral medication, one valdecoxib 40 mg tablet was administered by mouth once daily in the morning until a maximum period of 7 days.

Arms, Groups and Cohorts in this Clinical Trial

• Other: Arm 1

Primary Measures

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

Secondary Measures

• Visual Analog Scale Pain Intensity
  • Time Frame: Day 7
    Safety Issue?: No
• Categorical Pain Intensity
  • Time Frame: Day 3 and Day 7
    Safety Issue?: No
• Patient pain relief
  • Time Frame: Day 3 and Day 7
    Safety Issue?: 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
  • Time Frame: Study endpoint
    Safety Issue?: Yes
• Dyspepsia
  • Time Frame: Study endpoint
    Safety Issue?: Yes
• Adverse events
  • Time Frame: Day 1, Day 3, and Day 7
    Safety Issue?: Yes
• Patient Global Evaluation
  • Time Frame: Day 3 and Day 7
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

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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