PainPhase 3NCT00651300
A Study of the Recovery Benefits After Treatment With Parecoxib/Valdecoxib in Patients Undergoing Abdominal Surgery
A Phase 3 study testing Parecoxib/Valdecoxib in people with Pain, run by Pfizer at 8 sites in Australia.
Trial summary
The purpose of this study is to evaluate morphine intake in the first 4 hours after abdominal surgery. Morphine intake is compared between patients on placebo and patients on parecoxib/valdecoxib. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Parecoxib/Valdecoxib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 8 sitesAustralia
- Study dates
- Apr 2003to Mar 2004
- 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
- Male or female aged 18 to 65 years weighing at least 50 kg but no more than 110 kg undergoing elective intra-peritoneal laparoscopic abdominal surgery
- American Society of Anaesthesiologists (ASA) Physical Status I-III
Who cannot join
- Significant chronic disease, such as renal, hepatic, cardiovascular, or respiratory, which would contraindicate participation in the study or interfere with interpretation of study results
- Active gastrointestinal disease, chronic or acute renal or hepatic disorder, or known coagulation defect
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Australia8 sites
Pfizer Investigational Site
Coopers Plain, Queensland, 4108
Pfizer Investigational Site
Heidelberg, Victoria, 3084
Pfizer Investigational Site
Perth, Western Australia, 6847
Pfizer Investigational Site
Port Macquarie, New South Wales
Pfizer Investigational Site
Prahran, Victoria, 3181
Pfizer Investigational Site
Randwick, New South Wales, 2031
Pfizer Investigational Site
Townsville, Queensland, 4814
Pfizer Investigational Site
Westmead, New South Wales, 2145
About this study
Official title: A Multicentre, Double-Blind, Placebo-Controlled Study of the Recovery Benefits Following Treatment With a Cox-2 Regimen in Patients Undergoing Elective Laparoscopic Intra-Peritoneal Abdominal Surgery
The purpose of this study is to evaluate morphine intake in the first 4 hours after abdominal surgery. Morphine intake is compared between patients on placebo and patients on parecoxib/valdecoxib.
Read the detailed description
This study was prematurely terminated because subject recruitment was slower than expected, it was determined that the study was not going to achieve the statistical power necessary to address the primary objective. Letters were sent to the sites informing them of study termination on 26 February 2004. The decision to terminate the trial was not based on any safety concerns.
- Conditions
- Pain
- Being tested
- Parecoxib/Valdecoxib, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parecoxib/ValdecoxibDrug
A single 40mg dose of intravenous (IV) parecoxib sodium administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of valdecoxib 40 mg (2 x 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3
PlaceboDrug
A single dose of IV saline (placebo) administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of placebo (2 x matching valdecoxib 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Drug: Parecoxib/Valdecoxib |
| Group 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group.
Measured: 4 hours
Secondary outcomes (9)
Evaluation of unplanned hospital admissions on Day 4.
Measured: 4 days
Health Outcomes Recovery Questionnaire on Days 2, 3, and 4.
Measured: 4 days
Collection of adverse events immediately before surgery, 1 and 6 hours after surgery, and on Days 2, 3, and 4.
Measured: 4 days
Length of stay on Day 1.
Measured: 1 day
Patient Satisfaction Questionnaire on Days 1 and 4.
Measured: 4 days
Quality of Recovery Score on Days 1, 2, and 3.
Measured: 3 days
Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4.
Measured: 4 days
Modified Brief Pain Inventory on Days 2, 3, and 4.
Measured: 4 days
Readiness for discharge on Day 1.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startApr 2003
- Study completionMar 2004
Why it stopped: See Detailed Description field.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 91 participants (actual)
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
- NCT00651300
- Sponsor's protocol ID
- PARA-0505-086
- Other IDs
- A3481026
- Status last verified
- Jun 2009
- First submitted
- 31 Mar 2008
- Last updated
- 11 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Double-Blind, Placebo-Controlled Study of the Recovery Benefits Following Treatment With a Cox-2 Regimen in Patients Undergoing Elective Laparoscopic Intra-Peritoneal Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00651300
- Acronym / sponsor ID
- PARA-0505-086
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See Detailed Description field.
- Enrolment
- 91 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- Mar 2004 (actual)
- First posted
- 2 Apr 2008 (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.
The purpose of this study is to evaluate morphine intake in the first 4 hours after abdominal surgery. Morphine intake is compared between patients on placebo and patients on parecoxib/valdecoxib.
Detailed description
This study was prematurely terminated because subject recruitment was slower than expected, it was determined that the study was not going to achieve the statistical power necessary to address the primary objective. Letters were sent to the sites informing them of study termination on 26 February 2004. The decision to terminate the trial was not based on any safety concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Parecoxib/Valdecoxib |
| Group 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged 18 to 65 years weighing at least 50 kg but no more than 110 kg undergoing elective intra-peritoneal laparoscopic abdominal surgery
- American Society of Anaesthesiologists (ASA) Physical Status I-III
Key exclusion criteria (2 listed)
- Significant chronic disease, such as renal, hepatic, cardiovascular, or respiratory, which would contraindicate participation in the study or interfere with interpretation of study results
- Active gastrointestinal disease, chronic or acute renal or hepatic disorder, or known coagulation defect
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/ValdecoxibA single 40mg dose of intravenous (IV) parecoxib sodium administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of valdecoxib 40 mg (2 x 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3 | Drug | Group 1 |
| PlaceboA single dose of IV saline (placebo) administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of placebo (2 x matching valdecoxib 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3 | Drug | Group 2 |
Primary outcome
Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group.
Time frame: 4 hours
9 secondary outcomes
Evaluation of unplanned hospital admissions on Day 4.
Time frame: 4 days
Health Outcomes Recovery Questionnaire on Days 2, 3, and 4.
Time frame: 4 days
Collection of adverse events immediately before surgery, 1 and 6 hours after surgery, and on Days 2, 3, and 4.
Time frame: 4 days
Length of stay on Day 1.
Time frame: 1 day
Patient Satisfaction Questionnaire on Days 1 and 4.
Time frame: 4 days
Quality of Recovery Score on Days 1, 2, and 3.
Time frame: 3 days
Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4.
Time frame: 4 days
Modified Brief Pain Inventory on Days 2, 3, and 4.
Time frame: 4 days
Readiness for discharge on Day 1.
Time frame: 1 day
Results and safety
The study was stopped early (reason given: See Detailed Description field.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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 testing Parecoxib/Valdecoxib in people with Pain, run by Pfizer at 8 sites in Australia.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 11 Jun 2009. 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 Australia. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: See Detailed Description field.). Results are not available in the source record.
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?
Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group. (time frame: 4 hours). 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 11 Jun 2009.