NCT00660855

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

First QC Date

April 1, 2008

Last Update Submit

April 21, 2008

Conditions

Pain, Post Surgical

Keywords

laparoscopy

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale Pain Intensity (0-100 mm), which was evaluated using the change from baseline

    Day 3

Secondary Outcomes (7)

  • Visual Analog Scale Pain Intensity

    Day 7

  • 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

  • Dyspepsia

    Study endpoint

  • +2 more secondary outcomes

Study Arms (1)

Arm 1

OTHER
Drug: parecoxib/valdecoxib

Interventions

parecoxib/valdecoxibDRUG

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

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who had undergone laparoscopic surgery
  • Patients in need of post-surgical analgesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Buenos Aires, C1230AAW, Argentina

Location

Pfizer Investigational Site

Buenos Aires, C1280AEB, Argentina

Location

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

parecoxibvaldecoxib

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 17, 2008

Study Start

June 1, 2004

Study Completion

July 1, 2004

Last Updated

April 22, 2008

Record last verified: 2008-04

Locations

AR(2)