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
NCT00660855
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- Patients who had undergone laparoscopic surgery
- Patients in need of post-surgical analgesia
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | 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 | |||
Official Title ICMJE | 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 | |||
Brief Summary | The objectives of this study were to assess the analgesic efficacy and safety of parecoxib/valdecoxib on post-laparoscopic surgery analgesia. | |||
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 ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Pain, Post Surgical | |||
Intervention ICMJE | 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. | |||
Study Arms ICMJE | Arm 1
Intervention: Drug: parecoxib/valdecoxib | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 4 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 21 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00660855 | |||
Other Study ID Numbers ICMJE | A3471107 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | April 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |