Laparoscopic CholecystectomyPhase 3NCT00661635
A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain
A Phase 3 study testing valdecoxib in people with Laparoscopic Cholecystectomy and Pain, run by Pfizer at 65 sites in United States.
Trial summary
To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Pain
- What is being tested?
- valdecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 490 participants
- Where
- 65 sitesUnited States
- Study dates
- Nov 2002to Jul 2003
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients had required an elective, non-urgent laparoscopic cholecystectomy, as an outpatient procedure, with ASA Class I-III, with a Baseline Pain Intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS (100 mm)
- Patients were able to get their first dose of study medication within 8 hours after the end of surgery
Who cannot join
- Patients could not undergo procedures expected to produce a greater degree of surgical trauma than the laparoscopic cholecystectomy alone, nor have acute pre-operative pain (other than biliary colic) nor chronic pain conditions, nor uncontrolled chronic conditions, nor cancer, nor a laboratory abnormality that the investigator considered to contraindicate study participation
- Patient had any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures
- Patient had a history of known alcohol, analgesic, or narcotic substance abuse within the one year prior to Screening
- Patient had any laboratory abnormality at screening, that, in the opinion of the investigator, is not due to the condition requiring surgery and is not expected to resolve post-surgery, and would, therefore, contraindicate study participation
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
United States65 sites
Pfizer Investigational Site
Allentown, Pennsylvania, 18103
Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
Bakersfield, California, 93309
Pfizer Investigational Site
Bakersfield, California, 93311
Pfizer Investigational Site
Baltimore, Maryland, 21229
Pfizer Investigational Site
Birmingham, Alabama, 35213
Pfizer Investigational Site
Blue Ridge, Georgia, 30513
Pfizer Investigational Site
Bristol, Tennessee, 37620
Pfizer Investigational Site
Charleston, South Carolina, 29406
Pfizer Investigational Site
Chicago, Illinois, 60611
Pfizer Investigational Site
Columbia, South Carolina, 29203
Pfizer Investigational Site
Columbia, South Carolina, 29209
Pfizer Investigational Site
Daphne, Alabama, 36526
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Fairhope, Alabama, 36532
Pfizer Investigational Site
Germantown, Maryland, 20874
Pfizer Investigational Site
Glendale, Arizona, 85306
Pfizer Investigational Site
Glendale, Arizona, 85308
Pfizer Investigational Site
Houston, Texas, 77024
Pfizer Investigational Site
Houston, Texas, 77055
Pfizer Investigational Site
Iowa City, Iowa, 52242
Pfizer Investigational Site
Jackson, Mississippi, 39202
Pfizer Investigational Site
Kingsport, Tennessee, 37660
Pfizer Investigational Site
Los Angeles, California, 90017
Pfizer Investigational Site
Los Angeles, California, 90057
Pfizer Investigational Site
Madison, Wisconsin, 53792
Pfizer Investigational Site
Marietta, Georgia, 30060
Pfizer Investigational Site
Maywood, Illinois, 60153
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Miami, Florida, 33176
Pfizer Investigational Site
Mobile, Alabama, 36617
Pfizer Investigational Site
Mobile, Alabama, 36693
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
Norfolk, Virginia, 23517
Pfizer Investigational Site
North Charleston, South Carolina, 29406
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73104
Pfizer Investigational Site
Pasadena, California, 91109
Pfizer Investigational Site
Pensacola, Florida, 32504
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107-4998
Pfizer Investigational Site
Phoenix, Arizona, 85006
Pfizer Investigational Site
Phoenix, Arizona, 85020
Pfizer Investigational Site
Phoenix, Arizona, 85023
Pfizer Investigational Site
Phoenix, Arizona, 85027
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15212
Pfizer Investigational Site
Renton, Washington, 98055
Pfizer Investigational Site
Renton, Washington, 98058-5010
Pfizer Investigational Site
Rockville, Maryland, 20850
Pfizer Investigational Site
Sacramento, California, 95817
Pfizer Investigational Site
San Antonio, Texas, 78224
Pfizer Investigational Site
San Jose, California, 95124
Pfizer Investigational Site
Sandy City, Utah, 84070
Pfizer Investigational Site
Sandy City, Utah, 84094
Pfizer Investigational Site
Sheffield, Alabama, 35660
Pfizer Investigational Site
Shreveport, Louisiana, 71105
Pfizer Investigational Site
Silver Spring, Maryland, 20902
Pfizer Investigational Site
Suffolk, Virginia, 23434
Pfizer Investigational Site
Summerville, South Carolina, 29485
Pfizer Investigational Site
Tucson, Arizona, 85710
Pfizer Investigational Site
Tucson, Arizona, 85711
Pfizer Investigational Site
Tucson, Arizona, 85712
Pfizer Investigational Site
Universal City, Texas, 78148
Pfizer Investigational Site
West Jordan, Utah, 84088
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103-3315
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Pfizer Investigational Site
Woodland, California, 95695
About this study
Official title: A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Placebo in Patients for Treatment of Post-Surgical Pain From Laparoscopic Cholecystectomy Surgery
To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery.
- Conditions
- Laparoscopic Cholecystectomy, Pain
- Being tested
- placebo, valdecoxib
- Keywords
- Laparoscopic Cholecystectomy Surgery, Acute Pain, Perioperative Pain
- Medical subject headings
- Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, placebo twice daily (BID) on Days 2 to 5
valdecoxibDrug
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg once daily (QD)on Days 2 to 5.
valdecoxibDrug
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg twice daily (BID) on Days 2 to 5.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: valdecoxib |
| Arm 2 | Active comparator | Not described Receives: Drug: valdecoxib |
| Arm 3 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's Global Evaluation of Study Medication
Measured: Day 2 and Day 3
Summed Pain Intensity (categorical) through 24 hours (SPI 24)
Measured: Day 2 and Day 3
Secondary outcomes (11)
Time-specific PI (VAS)
Measured: Days 2 to 5
Patient's Global Evaluation of Study Medication
Measured: Day 4 and Day 5
Time to first dose of rescue medication
Measured: Days 2 to 5
Percent of patients who took rescue medication on each study day
Measured: Days 2 to 5
Amount of rescue medication taken
Measured: Days 2 to 5
Time between doses of study medication
Measured: Days 2 to 5
Worst PI (derived from the mBPI-SF)
Measured: Days 2 to 5
Average PI (derived from the mBPI-SF)
Measured: Days 2 to 5
SPI 24 (categorical)
Measured: Day 4 and Day 5
Time-specific PI (categorical)
Measured: Days 2 to 5
SPI 24 (VAS)
Measured: Days 2 to 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startNov 2002
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 490 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
- NCT00661635
- Sponsor's protocol ID
- VALA-0513-145
- Other IDs
- A3471085
- Status last verified
- Mar 2008
- First submitted
- 31 Mar 2008
- Last updated
- 23 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Placebo in Patients for Treatment of Post-Surgical Pain From Laparoscopic Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT00661635
- Acronym / sponsor ID
- VALA-0513-145
- Conditions
- Laparoscopic Cholecystectomy, Pain
- Keywords
- Laparoscopic Cholecystectomy Surgery, Acute Pain, Perioperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Jul 2003 (actual)
- First posted
- 18 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.
To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: valdecoxib |
| Arm 2 | Active comparator | Drug: valdecoxib |
| Arm 3 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients had required an elective, non-urgent laparoscopic cholecystectomy, as an outpatient procedure, with ASA Class I-III, with a Baseline Pain Intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS (100 mm)
- Patients were able to get their first dose of study medication within 8 hours after the end of surgery
Key exclusion criteria (4 listed)
- Patients could not undergo procedures expected to produce a greater degree of surgical trauma than the laparoscopic cholecystectomy alone, nor have acute pre-operative pain (other than biliary colic) nor chronic pain conditions, nor uncontrolled chronic conditions, nor cancer, nor a laboratory abnormality that the investigator considered to contraindicate study participation
- Patient had any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures
- Patient had a history of known alcohol, analgesic, or narcotic substance abuse within the one year prior to Screening
- Patient had any laboratory abnormality at screening, that, in the opinion of the investigator, is not due to the condition requiring surgery and is not expected to resolve post-surgery, and would, therefore, contraindicate study participation
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 |
|---|---|---|
| placebovaldecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, placebo twice daily (BID) on Days 2 to 5 | Drug | Arm 3 |
| valdecoxibvaldecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg once daily (QD)on Days 2 to 5. | Drug | Arm 2 |
| valdecoxibvaldecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg twice daily (BID) on Days 2 to 5. | Drug | Arm 1 |
Primary outcome
Patient's Global Evaluation of Study Medication
Time frame: Day 2 and Day 3
Summed Pain Intensity (categorical) through 24 hours (SPI 24)
Time frame: Day 2 and Day 3
11 secondary outcomes
Time-specific PI (VAS)
Time frame: Days 2 to 5
Patient's Global Evaluation of Study Medication
Time frame: Day 4 and Day 5
Time to first dose of rescue medication
Time frame: Days 2 to 5
Percent of patients who took rescue medication on each study day
Time frame: Days 2 to 5
Amount of rescue medication taken
Time frame: Days 2 to 5
Time between doses of study medication
Time frame: Days 2 to 5
Worst PI (derived from the mBPI-SF)
Time frame: Days 2 to 5
Average PI (derived from the mBPI-SF)
Time frame: Days 2 to 5
SPI 24 (categorical)
Time frame: Day 4 and Day 5
Time-specific PI (categorical)
Time frame: Days 2 to 5
SPI 24 (VAS)
Time frame: Days 2 to 5
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 23 Apr 2008.
- 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
65 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 valdecoxib in people with Laparoscopic Cholecystectomy and Pain, run by Pfizer at 65 sites in United States.
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 4 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 23 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 65 sites in United States. 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 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?
Patient's Global Evaluation of Study Medication (time frame: Day 2 and Day 3). The study lists 2 primary outcomes in all. 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 23 Apr 2008.