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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

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ClinicalTrials.gov Identifier: NCT00660855
Recruitment Status : Terminated (See Detailed Description.)
First Posted : April 17, 2008
Last Update Posted : April 22, 2008
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Pain, Post Surgical Drug: parecoxib/valdecoxib Phase 4

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2004
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Arm 1 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.



Primary Outcome Measures :
  1. Visual Analog Scale Pain Intensity (0-100 mm), which was evaluated using the change from baseline [ Time Frame: Day 3 ]

Secondary Outcome Measures :
  1. Visual Analog Scale Pain Intensity [ Time Frame: Day 7 ]
  2. Categorical Pain Intensity [ Time Frame: Day 3 and Day 7 ]
  3. Patient pain relief [ Time Frame: Day 3 and Day 7 ]
  4. 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 ]
  5. Dyspepsia [ Time Frame: Study endpoint ]
  6. Adverse events [ Time Frame: Day 1, Day 3, and Day 7 ]
  7. Patient Global Evaluation [ Time Frame: Day 3 and Day 7 ]


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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660855


Locations
Argentina
Pfizer Investigational Site
Buenos Aires, Argentina, C1230AAW
Pfizer Investigational Site
Buenos Aires, Argentina, C1280AEB
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00660855     History of Changes
Other Study ID Numbers: A3471107
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008

Keywords provided by Pfizer:
laparoscopy

Additional relevant MeSH terms:
Parecoxib
Valdecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents