NCT00143169

Brief Summary

To validate the morphine-sparing effect and safety of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

8 active sites

Status
completed

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

September 1, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
Last Updated

April 15, 2008

Status Verified

November 1, 2005

First QC Date

August 31, 2005

Last Update Submit

April 14, 2008

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • To validate the morphine-sparing effect of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.

Secondary Outcomes (1)

  • To validate safety of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.

Interventions

Parecoxib and placeboDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergo gynecological or orthopedic surgery under epidural anesthesia

You may not qualify if:

  • A previous history of intolerance or hypersensitivity to any NSAID, cyclooxygenase-2 selective inhibitors, sulphonamides, or any of the excipients of parecoxib.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Pfizer Investigational Site

Guangzhou, Guangdong, 510080, China

Location

Pfizer Investigational Site

Shenyang, Liaoning, 110001, China

Location

Pfizer Investigational Site

Qingdao, Shandong, 266011, China

Location

Pfizer Investigational Site

Beijing, 100020, China

Location

Pfizer Investigational Site

Beijing, 100034, China

Location

Pfizer Investigational Site

Beijing, 100083, China

Location

Pfizer Investigational Site

Shanghai, 200025, China

Location

Pfizer Investigational Site

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

parecoxib

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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

September 1, 2004

Study Completion

June 1, 2005

Last Updated

April 15, 2008

Record last verified: 2005-11

Locations

CN(8)