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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Pain, Post Surgical

Intervention / Treatment
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* Drug: parecoxib/valdecoxib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Drug: parecoxib/valdecoxib<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale Pain Intensity (0-100 mm), which was evaluated using the change from baseline |  | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale Pain Intensity |  | Day 7 | 
| Categorical Pain Intensity |  | Day 3 and Day 7 | 
| Patient pain relief |  | Day 3 and Day 7 | 
| 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 | 
| Dyspepsia |  | Study endpoint | 
| Adverse events |  | Day 1, Day 3, and Day 7 | 
| Patient Global Evaluation |  | Day 3 and Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy