Pain, PostoperativePhase 3NCT00143169
Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain
A Phase 3 study of Pain, Postoperative, run by Pfizer at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 8 sitesChina
- Study dates
- Sep 2004to Jun 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergo gynecological or orthopedic surgery under epidural anesthesia
Who cannot join
- A previous history of intolerance or hypersensitivity to any NSAID, cyclooxygenase-2 selective inhibitors, sulphonamides, or any of the excipients of parecoxib.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Pfizer Investigational Site
Beijing, 100020
Pfizer Investigational Site
Beijing, 100034
Pfizer Investigational Site
Beijing, 100083
Pfizer Investigational Site
Guangzhou, Guangdong, 510080
Pfizer Investigational Site
Qingdao, Shandong, 266011
Pfizer Investigational Site
Shanghai, 200025
Pfizer Investigational Site
Shanghai, 200032
Pfizer Investigational Site
Shenyang, Liaoning, 110001
About this study
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Of Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain Following Orthopedic Or Gynecological Surgery
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.
- Conditions
- Pain, Postoperative
- Being tested
- Parecoxib and placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parecoxib and placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startSep 2004
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143169
- Sponsor's protocol ID
- A3481004
- Status last verified
- Nov 2005
- First submitted
- 31 Aug 2005
- Last updated
- 15 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Of Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain Following Orthopedic Or Gynecological Surgery
- ClinicalTrials.gov ID
- NCT00143169
- Acronym / sponsor ID
- A3481004
- Conditions
- Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Jun 2005
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergo gynecological or orthopedic surgery under epidural anesthesia
Key exclusion criteria (1 listed)
- A previous history of intolerance or hypersensitivity to any NSAID, cyclooxygenase-2 selective inhibitors, sulphonamides, or any of the excipients of parecoxib.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parecoxib and placebo | Drug | – |
Primary outcome
To validate the morphine-sparing effect of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.
1 secondary outcome
To validate safety of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Pain, Postoperative, run by Pfizer at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate the morphine-sparing effect of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2008.