Pain, PostoperativePhase 4PROSTATECTOMYNCT00346268
Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy
A Phase 4 study testing Morphine, Parecoxib in people with Pain, Postoperative, run by Pfizer at 4 sites in Germany.
Trial summary
The primary objective of this study is to demonstrate the opioid-sparing efficacy of parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the 24 hours after the end of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Morphine, Parecoxib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 4 sitesGermany
- Study dates
- Dec 2006to Sep 2010
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient's ASA physical status is 1 or 2 and he has a low risk (i.e.,<10%) of developing an acute coronary event within the next 10 years according to the PROCAM risk assessment calculator.
- The patient is scheduled to undergo routine radical prostatectomy performed under a standardized regimen of general anesthesia, and is expected to experience moderate to severe postsurgical pain in the absence of postoperative analgesia.
Who cannot join
- The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition such as a diagnosed chronic pain condition, which, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results
- The patient has a history or current presence of congestive heart failure (NYHA II-IV), established ischaemic heart disease, peripheral arterial disease and / or cerebrovascular disease.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Pfizer Investigational Site
Cologne, 50924
Pfizer Investigational Site
Essen, 45136
Pfizer Investigational Site
Heidelberg, 69121
Pfizer Investigational Site
Reutlingen, 72764
About this study
Official title: Randomized, Double-Blind Study Of The Morphine-Sparing Efficacy And Safety Of Parecoxib Sodium 40 Mg IV Followed By 20 Mg IV Every 12 Hours In The Treatment Of Pain Following Radical Prostatectomy
The primary objective of this study is to demonstrate the opioid-sparing efficacy of parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the 24 hours after the end of surgery.
Read the detailed description
The study was terminated due to lack of recruitment due to competing alternative operation methods on 13September 2010. The decision to terminate the trial was not based on any safety concerns.
- Conditions
- Pain, Postoperative
- Being tested
- Morphine, Parecoxib, Morphine, 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.
Morphine, ParecoxibDrug
Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
Morphine, PlaceboDrug
Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA
| Study group | Role | What they receive |
|---|---|---|
| Morphine plus Parecoxib | Active comparator | Not described Receives: Drug: Morphine, Parecoxib |
| Morphine and Placebo | Active comparator | Not described Receives: Drug: Morphine, Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery
Total cumulative amount of morphine administered (PCA and/or bolus) in the first 24 hours after the application of the last surgical stitch after prostatectomy.
Measured: 24 hours post surgery
Secondary outcomes (8)
Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery
Total cumulative amount of morphine administered (PCA and/or bolus) in the first 48 hours after the application of the last surgical stitch after prostatectomy.
Measured: 48 hours post surgery
Time to Last Administration of Morphine
Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).
Measured: baseline (end of surgery) to 48 hours post surgery
Amount of Blood Loss
Calculated as: ([Hb g/dL]pra + RBCUduring48)-[Hb g/dL]at 48, where [Hb g/dL]pra=blood hemoglobin concentration preoperatively in grams per deciliter (g/dL), [Hb g/dL]at 48=blood hemoglobin concentration 48 hours after skin closure, and RBCUduring48=number of red blood cell units (RBCU) substituted during and after prostatectomy until 48 hours after skin closure.
Measured: 48 hours post surgery
Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units
Measured: 48 hours post surgery
Pain Intensity Score
Pain intensity assessed immediately prior and 30 minutes after administration (admin) of study medication, participants categorized their pain intensity at rest and at movement on 0-4 numeric rating scale (NRS):0 (minimum intensity) to 4 (maximum intensity).
Movement defined as sitting up from a lying into a sitting position in bed.
Measured: 12, 24, 36, and 48 hours post surgery
Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score
mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Pain severity index=the mean of item scores 2 to 5 (pain at its worst in past 24 hours, pain at its least in past 24 hours, average pain level, and pain right now).
Measured: 24 and 48 hours post surgery
Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score
mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, coughing, deep breathing, and concentration) in past 24 hours.
Measured: 24 and 48 hours post surgery
Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score
Participant-rated scale assessed 10 common opiate related symptoms by 3 ordinal measures: frequency (1 to 4 scale: rarely to almost constantly), severity (1 to 4 scale: slight to very severe) and bothersomeness (1 to 5 scale: not at all to very much). Frequency and severity items assigned numeric scores 1 to 4. Bothersomeness items scaled in order to assign numeric scores 0.8 to 4.0 (not at all scored=0.8, a little bit=1.6, somewhat=2.4, quite a bit=3.2, and very much=4.0). Overall composite score=mean of each 10 individual mean symptoms' OR-SDS scores; ranged from 1 to 4.
Measured: 24 and 48 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study startDec 2006
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: See termination reason in detailed description.
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 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
- NCT00346268
- Sponsor's protocol ID
- A3481066
- Acronym
- PROSTATECTOMY
- Status last verified
- Sep 2011
- First submitted
- 28 Jun 2006
- Last updated
- 28 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dirkmann D, Groeben H, Farhan H, Stahl DL, Eikermann M. Effects of parecoxib on analgesia benefit and blood loss following open prostatectomy: a multicentre randomized trial. BMC Anesthesiol. 2015 Mar 9;15:31. doi: 10.1186/s12871-015-0015-y. eCollection 2015.
PubMed 25767411
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind Study Of The Morphine-Sparing Efficacy And Safety Of Parecoxib Sodium 40 Mg IV Followed By 20 Mg IV Every 12 Hours In The Treatment Of Pain Following Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00346268
- Acronym / sponsor ID
- PROSTATECTOMY / A3481066
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 105 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 29 Jun 2006 (estimated)
- Results
- Posted 28 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to demonstrate the opioid-sparing efficacy of parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the 24 hours after the end of surgery.
Detailed description
The study was terminated due to lack of recruitment due to competing alternative operation methods on 13September 2010. 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 |
|---|---|---|
| Morphine plus Parecoxib | Active comparator | Drug: Morphine, Parecoxib |
| Morphine and Placebo | Active comparator | Drug: Morphine, Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient's ASA physical status is 1 or 2 and he has a low risk (i.e.,<10%) of developing an acute coronary event within the next 10 years according to the PROCAM risk assessment calculator.
- The patient is scheduled to undergo routine radical prostatectomy performed under a standardized regimen of general anesthesia, and is expected to experience moderate to severe postsurgical pain in the absence of postoperative analgesia.
Key exclusion criteria (2 listed)
- The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition such as a diagnosed chronic pain condition, which, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results
- The patient has a history or current presence of congestive heart failure (NYHA II-IV), established ischaemic heart disease, peripheral arterial disease and / or cerebrovascular disease.
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 |
|---|---|---|
| Morphine, ParecoxibParecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA. | Drug | Morphine plus Parecoxib |
| Morphine, PlaceboMatching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA | Drug | Morphine and Placebo |
Primary outcome
Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery
Time frame: 24 hours post surgery
Total cumulative amount of morphine administered (PCA and/or bolus) in the first 24 hours after the application of the last surgical stitch after prostatectomy.
8 secondary outcomes
Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery
Time frame: 48 hours post surgery
Time to Last Administration of Morphine
Time frame: baseline (end of surgery) to 48 hours post surgery
Amount of Blood Loss
Time frame: 48 hours post surgery
Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units
Time frame: 48 hours post surgery
Pain Intensity Score
Time frame: 12, 24, 36, and 48 hours post surgery
Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score
Time frame: 24 and 48 hours post surgery
Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score
Time frame: 24 and 48 hours post surgery
Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score
Time frame: 24 and 48 hours post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25767411Dirkmann D, Groeben H, Farhan H, Stahl DL, Eikermann M. Effects of parecoxib on analgesia benefit and blood loss following open prostatectomy: a multicentre randomized trial. BMC Anesthesiol. 2015 Mar 9;15:31. doi: 10.1186/s12871-015-0015-y. eCollection 2015.
- 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine, Parecoxib in people with Pain, Postoperative, run by Pfizer at 4 sites in Germany.
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 28 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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 Oct 2011). 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?
Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery (time frame: 24 hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00346268, which also lists 1 linked publication.
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 Oct 2011.