Not provided
Not provided
Not provided
Not provided
See termination reason in detailed description.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine plus Parecoxib | Active Comparator |
| |
| Morphine and Placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine, Parecoxib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours post surgery |
| Time to Last Administration of Morphine |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours post surgery |
| Number of Participants With Health Care Resource Utilization (HCRU) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Cologne | 50924 | Germany | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25767411 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
This study was terminated prematurely due to slow recruitment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Parecoxib and Morphine | 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. |
| FG001 | Placebo and Morphine | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Parecoxib and Morphine | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set Population (FAS): participants who were randomized to treatment | Posted | Mean | Standard Deviation | mL | 24 hours post surgery |
|
Not provided
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parecoxib and Morphine | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphatic disorder | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
This study was terminated prematurely due to slow recruitment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D009020 | Morphine |
| C409945 | parecoxib |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Morphine, Placebo | Drug | 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 |
|
Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus). |
| 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. | 48 hours post surgery |
| Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units | 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. | 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). | 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. | 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. | 24 and 48 hours post surgery |
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". |
| 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. | 24 and 48 hours post surgery |
| Hemoglobin Concentration | 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. | 24 hours post surgery |
| Essen |
| 45136 |
| Germany |
| Pfizer Investigational Site | Heidelberg | 69121 | Germany |
| Pfizer Investigational Site | Reutlingen | 72764 | Germany |
| Participant refused |
|
| BG001 |
| Placebo and Morphine |
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. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Placebo and Morphine |
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. |
|
|
|
| Secondary | 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. | FAS | Posted | Mean | Standard Deviation | mL | 48 hours post surgery |
|
|
|
|
| Secondary | Time to Last Administration of Morphine | Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus). | FAS; Number of participants analyzed (N)=participants with evaluable data | Posted | Median | Full Range | hours | baseline (end of surgery) to 48 hours post surgery |
|
|
|
|
| Secondary | 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. | FAS | Posted | Mean | Standard Deviation | g/dL | 48 hours post surgery |
|
|
|
|
| Secondary | Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units | FAS | Posted | Number | participants | 48 hours post surgery |
|
|
|
| Secondary | 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. | FAS; N=participants with evaluable data | Posted | Mean | Standard Deviation | scores on a scale | 12, 24, 36, and 48 hours post surgery |
|
|
|
|
| Secondary | 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). | FAS; N=participants with evaluable data; n=participants with evaluable for specified category; for analyses, missing values imputed using Last-Observation-Carried-Forward (LOCF) method. | Posted | Mean | Standard Deviation | scores on a scale | 24 and 48 hours post surgery |
|
|
|
|
| Secondary | 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. | FAS; N=participants with evaluable data; n=participants with evaluable data for specified category; for analyses, missing values imputed using LOCF method. | Posted | Mean | Standard Deviation | scores on a scale | 24 and 48 hours post surgery |
|
|
|
|
| Secondary | 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. | FAS; N=participants with evaluable data. | Posted | Mean | Standard Deviation | scores on scale | 24 and 48 hours post surgery |
|
|
|
| Other Pre-specified | 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. | FAS; N=participants with evaluable data. | Posted | Number | participants | 48 hours post surgery |
|
|
|
| Other Pre-specified | 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". | Data not analyzed due to study termination. | Posted | Number | participants | 24 and 48 hours post surgery |
|
|
| Other Pre-specified | 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. | Data not analyzed due to study termination. | Posted | Number | scores on a scale | 24 and 48 hours post surgery |
|
|
| Other Pre-specified | Hemoglobin Concentration | Data not analyzed due to study termination. | Posted | Number | g/dL | 24 hours post surgery |
|
|
| Other Pre-specified | 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. | Data not analyzed due to study termination. | Posted | Number | mL | 24 hours post surgery |
|
|
| 12 |
| 52 |
| 35 |
| 52 |
| EG001 | Placebo and Morphine | 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. | 5 | 53 | 38 | 53 |
| Angina pectoris | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Infected lymphocele | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pelvic haematoma | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Lymphatic fistula | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Lymphocele | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| At movement, prior to admin, 12 hours post surgery |
|
| At movement, post admin, 12 hours post surgery |
|
| At rest, prior to admin, 24 hours post surgery |
|
| At rest, post admin, 24 hours post surgery |
|
| At movement, prior to admin, 24 hours post surgery |
|
| At movement, post admin, 24 hours post surgery |
|
| At rest, prior to admin, 36 hours post surgery |
|
| At rest, post admin, 36 hours post surgery |
|
| At movement, prior to admin, 36 hours post surgery |
|
| At movement, post admin, 36 hours post surgery |
|
| At rest, prior to admin, 48 hours post surgery |
|
| At rest, post admin, 48 hours post surgery |
|
| At movement, prior to admin, 48 hours post surgery |
|
| At movement, post admin, 48 hours post surgery |
|
The difference in pain at movement prior to administration and pain at movement post administration compared between treatments at 48 hours post surgery.
| ANOVA |
| 0.074 |
| LS Mean Difference (net) |
| 0.16 |
| Standard Error of the Mean |
| 0.09 |
| 2-Sided |
| 95 |
| -0.02 |
| 0.33 |
| No |
| Superiority or Other |
48 hours post surgery
| ANOVA |
| 0.004 |
Adjusted for treatment group and center |
| LS mean difference (net) |
| -0.73 |
| Standard Error of the Mean |
| 0.25 |
| 2-Sided |
| 95 |
| -1.22 |
| -0.23 |
| No |
| Superiority or Other |
48 hours post surgery
| ANOVA |
| 0.006 |
Adjusted for treatment group and center |
| LS mean difference (net) |
| -0.83 |
| Standard Error of the Mean |
| 0.30 |
| 2-Sided |
| 95 |
| -1.41 |
| -0.24 |
| No |
| Superiority or Other |
| Good |
|
| Excellent |
|