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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00660855

Enrollment

Registered

2008-04-17

Start date

2004-06-30

Completion date

2004-07-31

Last updated

2008-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Post Surgical

Keywords

laparoscopy

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.

Interventions

DRUGparecoxib/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 design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Visual Analog Scale Pain Intensity	Day 7
Adverse events	Day 1, Day 3, and Day 7
Patient Global Evaluation	Day 3 and Day 7
Dyspepsia	Study endpoint

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026