PainPhase 4NAPNCT00553605
Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic
A Phase 4 study testing Ketoprofen 100mg and Parecoxib 40mg in people with Pain, run by Pfizer at 17 sites in 6 countries.
Trial summary
This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib 40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in outpatients presenting at emergency… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Ketoprofen 100mg and Parecoxib 40mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 17 sitesin 6 countries
- Study dates
- Jun 2007to Jun 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient male or female with a confirmed diagnosis of acute renal colic with moderate to severe pain according to the VAS and Categoric pain scales
Who cannot join
- The patient has significant renal or hepatic conditions other than uncomplicated kidney stones.
- The patient has a history of clinically significant hypersensitivity to any NSAIDs, cyclooxygenase inhibitors, analgesics or sulfa medications which has a cross sensitivity to the medications used in this study.
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
Brazil9 sites
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-003
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000
Pfizer Investigational Site
Ribeirão Preto, São Paulo, 14015-130
Pfizer Investigational Site
Ribeirão Preto, São Paulo, 14048-900
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, CEP 20551-030
Pfizer Investigational Site
São Bernardo do Campo, São Paulo, 09715-090
Pfizer Investigational Site
São Paulo, São Paulo, 04262-000
Pfizer Investigational Site
São Paulo, São Paulo, 04321-120
Pfizer Investigational Site
Vila Mariana - São Paulo, São Paulo, 04122-000
Costa Rica3 sites
Pfizer Investigational Site
Alajuela, Alajuela Province
Pfizer Investigational Site
Desamparados, Provincia de San José
Pfizer Investigational Site
San José, Provincia de San José
Peru2 sites
Pfizer Investigational Site
Lima, Lima Province, L 31
Pfizer Investigational Site
Lima, Lima Province, L27
About this study
Official title: A Double-Blind, Double-Dummy, Randomized, Multicenter Study Comparing The Analgesic Efficacy And Safety Of Parecoxib 40mg I.V. To Ketoprofen 100mg I.V. In Renal Colic
This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib 40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in outpatients presenting at emergency room settings. This trial is designed to show non-inferiority of parecoxib related to ketoprofen.
- Conditions
- Pain
- Being tested
- Ketoprofen 100mg, Parecoxib 40mg
- Keywords
- Renal Colic Pain Urinary Tract Colic
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketoprofen 100mgDrug
Ketoprofen 100 mg diluted in 100 ml of normal sodium chloride solution into the established patient's IV line by slow injection in a 20-minute period; and IV dose of 2 ml of normal sodium chloride solution as placebo for Parecoxib by bolus injection
Parecoxib 40mgDrug
Parecoxib 40 mg diluted in 2 ml of normal sodium chloride solution administered by bolus injection; and an IV dose of 100 ml of normal sodium chloride solution as placebo for ketoprofen administered in a in a 20-minute period
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Ketoprofen plus placebo parecoxib Receives: Drug: Ketoprofen 100mg |
| II | Active comparator | Parecoxib plus placebo ketoprofen Receives: Drug: Parecoxib 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Pain Intensity Difference at 30 Minutes (mPID30min)
mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 30 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 30 from baseline PI-VAS score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.
Measured: Minute 30
Secondary outcomes (9)
Mean Pain Intensity Difference at 120 Min (mPID120min)
mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 120 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 120 from baseline PI-VAS score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.
Measured: Minute 120
Time-specific Pain Intensity (PI) VAS Score
PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain.
Measured: Baseline, Minute 15, 30, 45, 60, 90, 120
Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120
PID score was obtained by subtracting the PI-VAS at each time point from baseline PI score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. PID score ranged from -100 to 100. Positive score= improved response in pain.
Measured: Baseline, Minute 15, 30, 45, 60, 90, 120
Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)
TOTPAR: time-weighted sum of Pain Relief (PR) over 120 min. TOTPAR score range was 0 (worst) to 480 (best). PR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.
Measured: Baseline through Minute 120
Number of Participants With Pain Relief (PR)
PR was assessed on a 5-point categorical pain relief rating scale wherein 0= None, 1= a little, 2= Some, 3= a lot and 4= Complete relief.
Measured: Minute 30, 120
Number of Participants With Response in Pain Intensity
PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. Responders were those who had a decreased in VAS of at least 20 mm.
Measured: Minute 30
Patient's Global Evaluation of Study Medication
Participants' response to the question "How would you rate the study medication you received for pain?" on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated.
Measured: Minute 30, 120
Physician's Global Evaluation of Study Medication
Physicians' response to the question "How would you rate the study medication the patient received for pain?" on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated.
Measured: Minute 30, 120
Number of Participants With Use of Rescue Medication (RM)
Rescue medications included intravenous 0.1 to 0.2 mg/kilogram (kg) of morphine or 1 mg/kg of pethidine or muscle relaxants.
Measured: Up to Minute 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553605
- Sponsor's protocol ID
- A3481065
- Acronym
- NAP
- Status last verified
- Dec 2012
- First submitted
- 2 Nov 2007
- Last updated
- 28 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Double-Dummy, Randomized, Multicenter Study Comparing The Analgesic Efficacy And Safety Of Parecoxib 40mg I.V. To Ketoprofen 100mg I.V. In Renal Colic
- ClinicalTrials.gov ID
- NCT00553605
- Acronym / sponsor ID
- NAP / A3481065
- Conditions
- Pain
- Keywords
- Renal Colic Pain Urinary Tract Colic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 5 Nov 2007 (estimated)
- Results
- Posted 28 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib 40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in outpatients presenting at emergency room settings. This trial is designed to show non-inferiority of parecoxib related to ketoprofen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Drug: Ketoprofen 100mgKetoprofen plus placebo parecoxib |
| II | Active comparator | Drug: Parecoxib 40mgParecoxib plus placebo ketoprofen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient male or female with a confirmed diagnosis of acute renal colic with moderate to severe pain according to the VAS and Categoric pain scales
Key exclusion criteria (2 listed)
- The patient has significant renal or hepatic conditions other than uncomplicated kidney stones.
- The patient has a history of clinically significant hypersensitivity to any NSAIDs, cyclooxygenase inhibitors, analgesics or sulfa medications which has a cross sensitivity to the medications used in this study.
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 |
|---|---|---|
| Ketoprofen 100mgKetoprofen 100 mg diluted in 100 ml of normal sodium chloride solution into the established patient's IV line by slow injection in a 20-minute period; and IV dose of 2 ml of normal sodium chloride solution as placebo for Parecoxib by bolus injection | Drug | I |
| Parecoxib 40mgParecoxib 40 mg diluted in 2 ml of normal sodium chloride solution administered by bolus injection; and an IV dose of 100 ml of normal sodium chloride solution as placebo for ketoprofen administered in a in a 20-minute period | Drug | II |
Primary outcome
Mean Pain Intensity Difference at 30 Minutes (mPID30min)
Time frame: Minute 30
mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 30 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 30 from baseline PI-VAS score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.
9 secondary outcomes
Mean Pain Intensity Difference at 120 Min (mPID120min)
Time frame: Minute 120
Time-specific Pain Intensity (PI) VAS Score
Time frame: Baseline, Minute 15, 30, 45, 60, 90, 120
Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120
Time frame: Baseline, Minute 15, 30, 45, 60, 90, 120
Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)
Time frame: Baseline through Minute 120
Number of Participants With Pain Relief (PR)
Time frame: Minute 30, 120
Number of Participants With Response in Pain Intensity
Time frame: Minute 30
Patient's Global Evaluation of Study Medication
Time frame: Minute 30, 120
Physician's Global Evaluation of Study Medication
Time frame: Minute 30, 120
Number of Participants With Use of Rescue Medication (RM)
Time frame: Up to Minute 120
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketoprofen 100mg and Parecoxib 40mg in people with Pain, run by Pfizer at 17 sites in 6 countries.
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 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: finished, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Brazil, Costa Rica, Peru, Chile, Ecuador and 1 more country. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Pain Intensity Difference at 30 Minutes (mPID30min) (time frame: Minute 30). 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 28 Jan 2013.