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

Pain, Post Surgical Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00660855
• Other study ID #: A3471107
• Status: Terminated
• Phase: Phase 4
• First received: April 1, 2008
• Last updated: April 21, 2008
• Start date: June 2004
• Est. completion date: July 2004

Study information

• Verified date: April 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Post Surgical

Intervention

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.

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Secondary	Categorical Pain Intensity		Day 3 and Day 7	No
Secondary	Patient pain relief		Day 3 and Day 7	No
Secondary	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
Secondary	Dyspepsia		Study endpoint	Yes
Secondary	Adverse events		Day 1, Day 3, and Day 7	Yes
Secondary	Patient Global Evaluation		Day 3 and Day 7	No

External Links

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