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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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NCT00660855

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Buenos Aires, , C1230AAW Argentina
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Post Surgical Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients who had undergone laparoscopic surgery

- Patients in need of post-surgical analgesia

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00660855
Pfizer
Terminated
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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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
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.
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.
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pain, Post Surgical
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.
Arm 1
Intervention: Drug: parecoxib/valdecoxib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
July 2004
Not Provided

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
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
 
NCT00660855
A3471107
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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