A Phase 4 interventional study of Morphine, Parecoxib and Morphine, Placebo in Pain, Postoperative, sponsored by Pfizer. Terminated at 4 sites in Germany. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-28.
Sponsored by Pfizer · Phase 4, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 105 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Morphine, Parecoxib
Drug: Morphine, Placebo
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.
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
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.
Time frame: 24 hours post surgery
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.
Time frame: 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).
Time frame: 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.
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
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 24 and 48 hours post surgery
Number of Participants With Rating of Global Evaluation of Study Medication
Participants asked, "How would you rate the study medication you received for pain since your surgery?" choices included: Poor, Fair, Good, and Excellent.
Time frame: 48 hours post surgery
Number of Participants With Health Care Resource Utilization (HCRU)
Supervising physician or nurse answered question in the presence of participant, "In the last 24 hours, did the participant receive any unscheduled consultation from any of the following specialist: anesthesiologist, surgeon, nurse or other specialist".
Time frame: 24 and 48 hours post surgery
Overall Analgesic Benefit Score (OABS)
Participants' rating of global assessment of analgesic experience. OABS comprised of scores for symptoms (vomiting, itching, sweating, freezing, and dizziness) and patient satisfaction; Participants asked how much did symptoms distress and bother them during the last 24 hours; Participants asked how satisfied they have been with treatment of pain during last 24 hours. Each symptom and satisfaction question scored from 0 (not at all) to 4 (very much so). Total possible score=0 to 24.
Time frame: 24 and 48 hours post surgery
Hemoglobin Concentration
Time frame: 24 hours post surgery
Total Amount of Postoperative Drainage Fluid
After removal of the prostate and placement of the urine catheter, at least one easy-flow drainage was placed in the perivesical space. Drainage fluid (a mixture with a variable combination of blood and urine) was measured.
Time frame: 24 hours post surgery
This study was terminated prematurely due to slow recruitment.
| Milestone | Parecoxib and Morphine | Placebo and Morphine |
|---|---|---|
| Started | 52 | 53 |
| Completed | 50 | 50 |
| Not completed | 2 | 3 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Participant refused | 0 | 3 |
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.
| mL | Parecoxib and Morphine | Placebo and Morphine |
|---|---|---|
| Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery | 28.84 ± 16.16 | 36.40 ± 19.99 |
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.
| mL | Parecoxib and Morphine | Placebo and Morphine |
|---|---|---|
| Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery | 42.13 ± 25.02 | 57.03 ± 28.07 |
Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).
| hours | Parecoxib and Morphine | Placebo and Morphine |
|---|---|---|
| Time to Last Administration of Morphine | 46.5 (1.9 to 123.7) | 46.5 (21.8 to 90.3) |
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.
| g/dL | Parecoxib and Morphine | Placebo and Morphine |
|---|---|---|
| Amount of Blood Loss | 4.34 ± 1.40 | 4.41 ± 2.12 |
| participants | Parecoxib and Morphine | Placebo and Morphine |
|---|---|---|
| 1 RBC transfused unit | 1 | 1 |
| 2 RBC transfused units | 4 | 1 |
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.
| scores on a scale | Parecoxib and Morphine | Placebo and Morphine |
|---|---|---|
| At rest, prior to admin, 12 hours post surgery | 1.31 ± 0.76 | 1.69 ± 0.95 |
| At rest, post admin, 12 hours post surgery | 0.53 ± 0.67 | 0.79 ± 0.78 |
| At movement, prior to admin, 12 hours post surgery | 2.12 ± 0.86 | 2.63 ± 0.95 |
| At movement, post admin, 12 hours post surgery | 1.16 ± 0.88 | 1.58 ± 1.02 |
| At rest, prior to admin, 24 hours post surgery | 1.00 ± 0.82 | 1.44 ± 0.94 |
| At rest, post admin, 24 hours post surgery | 0.53 ± 0.76 | 0.67 ± 0.73 |
| At movement, prior to admin, 24 hours post surgery | 2.12 ± 0.86 | 2.63 ± 0.77 |
| At movement, post admin, 24 hours post surgery | 1.45 ± 1.05 | 1.90 ± 0.96 |
| At rest, prior to admin, 36 hours post surgery | 0.86 ± 0.94 | 1.04 ± 0.87 |
| At rest, post admin, 36 hours post surgery | 0.45 ± 0.61 | 0.59 ± 0.73 |
| At movement, prior to admin, 36 hours post surgery | 1.59 ± 0.98 | 2.12 ± 1.03 |
| At movement, post admin, 36 hours post surgery | 1.04 ± 0.89 | 1.51 ± 0.92 |
| At rest, prior to admin, 48 hours post surgery | 0.67 ± 1.07 | 0.82 ± 0.97 |
| At rest, post admin, 48 hours post surgery | 0.29 ± 0.54 | 0.29 ± 0.58 |
| At movement, prior to admin, 48 hours post surgery | 1.47 ± 1.16 | 2.31 ± 0.97 |
| At movement, post admin, 48 hours post surgery | 0.88 ± 0.86 | 1.41 ± 0.98 |
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).
| scores on a scale | Parecoxib and Morphine | Placebo and Morphine |
|---|---|---|
| 24 hours post surgery (n=49, 50) | 2.08 ± 1.17 | 2.78 ± 1.06 |
| 48 hours post surgery (n=43, 48) | 1.60 ± 1.26 | 2.31 ± 1.17 |
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.
| scores on a scale | Parecoxib and Morphine | Placebo and Morphine |
|---|---|---|
| 24 hours post surgery (n=49, 50) | 1.16 ± 1.21 | 2.32 ± 1.78 |
| 48 hours post surgery (n=43, 48) | 1.00 ± 1.41 | 1.79 ± 1.50 |
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.
| scores on scale | Parecoxib and Morphine | Placebo and Morphine |
|---|---|---|
| 24 hours post surgery | 0.50 ± 0.35 | 0.55 ± 0.39 |
| 48 hours post surgery | 0.26 ± 0.28 | 0.34 ± 0.34 |
Participants asked, "How would you rate the study medication you received for pain since your surgery?" choices included: Poor, Fair, Good, and Excellent.
| participants | Parecoxib and Morphine | Placebo and Morphine |
|---|---|---|
| Poor | 1 | 3 |
| Fair | 3 | 5 |
| Good | 19 | 31 |
| Excellent | 27 | 11 |
Supervising physician or nurse answered question in the presence of participant, "In the last 24 hours, did the participant receive any unscheduled consultation from any of the following specialist: anesthesiologist, surgeon, nurse or other specialist".
No measurements were reported for this outcome.
Participants' rating of global assessment of analgesic experience. OABS comprised of scores for symptoms (vomiting, itching, sweating, freezing, and dizziness) and patient satisfaction; Participants asked how much did symptoms distress and bother them during the last 24 hours; Participants asked how satisfied they have been with treatment of pain during last 24 hours. Each symptom and satisfaction question scored from 0 (not at all) to 4 (very much so). Total possible score=0 to 24.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
After removal of the prostate and placement of the urine catheter, at least one easy-flow drainage was placed in the perivesical space. Drainage fluid (a mixture with a variable combination of blood and urine) was measured.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Parecoxib and Morphine | — | 12/52 (23.1%) | 35/52 (67.3%) |
| Placebo and Morphine | — | 5/53 (9.4%) | 38/53 (71.7%) |
| Event | Parecoxib and Morphine | Placebo and Morphine |
|---|---|---|
| LymphoceleVascular disorders | 4/52 | 2/53 |
| Urinary tract infectionInfections and infestations | 2/52 | 0/53 |
| Urinary retentionRenal and urinary disorders | 2/52 | 0/53 |
| Lymphatic disorderBlood and lymphatic system disorders | 1/52 | 0/53 |
| Angina pectorisCardiac disorders | 1/52 | 0/53 |
| Infected lymphoceleInfections and infestations | 1/52 | 0/53 |
| ParaesthesiaNervous system disorders | 1/52 | 0/53 |
| Renal failure acuteRenal and urinary disorders | 1/52 | 0/53 |
| Pelvic haematomaReproductive system and breast disorders | 1/52 | 0/53 |
| Deep vein thrombosisVascular disorders | 1/52 | 0/53 |
| Event | Parecoxib and Morphine | Placebo and Morphine |
|---|---|---|
| NauseaGastrointestinal disorders | 12/52 | 16/53 |
| FlatulenceGastrointestinal disorders | 6/52 | 10/53 |
| VomitingGastrointestinal disorders | 9/52 | 4/53 |
| DiarrhoeaGastrointestinal disorders | 4/52 | 8/53 |
| ConstipationGastrointestinal disorders | 2/52 | 7/53 |
| Urinary tract infectionInfections and infestations | 6/52 | 7/53 |
| AnaemiaBlood and lymphatic system disorders | 6/52 | 4/53 |
| HypertensionVascular disorders | 6/52 | 4/53 |
| PyrexiaGeneral disorders | 1/52 | 4/53 |
| Abdominal painGastrointestinal disorders | 3/52 | 1/53 |
| Age, Customized(participants) | Parecoxib and Morphine | Placebo and Morphine | Total |
|---|---|---|---|
| < 45 years | 0 | 0 | 0 |
| Between 45 and 59 years | 14 | 13 | 27 |
| Between 60 and 74 years | 36 | 38 | 74 |
| >= 75 years | 2 | 2 | 4 |
| Sex: Female, Male(Participants) | Parecoxib and Morphine | Placebo and Morphine | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 52 | 53 | 105 |
This study is terminated, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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