| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Patients who are scheduled to undergo routine radical prostatectomy performed under a standardized regimen of general anesthesia, and who are expected to experience moderate to severe postsurgical pain in the absence of postoperative analgesia. |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 8.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10054711 |
| E.1.2 | Term | Postoperative pain |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| The primary objective of this study is to demonstrate the opioid-sparing efficacy of parecoxib 40 mg i.v. given as a loading dose followed by 20 mg i.v. in the 24 hours after the end of surgery. |
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| E.2.2 | Secondary objectives of the trial |
| The secondary objective is to evaluate the overall safety and efficacy of multiple doses of parecoxib following radical prostatectomy. In particular, we evaluate if administration of multiple doses of parecoxib is associated with an increased blood loss. |
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| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Title: Platelet function under placebo and parecoxib
Date: 30 Oct 2006; Final Version
Objectives: The objective of this sub-study is to investigate the thromboxane B2 (TxB2-)-formation, the platelet aggregation in response to arachidonic acid and collagen, and the formation of the endogenous thrombin potential (ETP) of patients that underwent prostatectomy and postoperative pain management according to protocol A3481066. The aim is to compare the effects of pain management with parecoxib treated patients with the effects of placebo treated patients.
Parameters will be assessed at the following time points: pre-dose (0h), 2h post-dose, 6 h post-dose and 24 h post-dose.
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| E.3 | Principal inclusion criteria |
1. The subject is at least 18 years of age or older. 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.
2. Independent of this trial, the patient is planned to receive standard PCA morphine for postoperative analgesia.
3. 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.
4. The patient is in satisfactory health condition as determined by the investigator on the basis of medical history and physical examination.
5. The subject has provided written informed consent prior to any study specific test or procedure being performed, or medication being changed, for this study.
6. The patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
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| E.4 | Principal exclusion criteria |
1. 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.
2. The patient has any cognitive impairment that would, in the Investigator’s opinion, preclude study participation or compliance with protocol mandated procedures.
3. The patient has active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 60 days prior to receiving the first dose of study medication.
4. The patient has used antidepressants (including MAO-Inhibitors), hypnotics, (narcotic) analgesics, NSAIDs, other coxibs, antihistamines, anxiolytics, sedatives, corticosteroids (inhaled corticosteroids are allowed), opioids or other similar agents during the 24 hours preceding surgery, with the exception of routine pre-operative anxiolytic medication. Long acting NSAIDs (e.g., oxaprozin, piroxicam), acetylsalicylic acid or clopidogrel and other anti-platelet drugs should be stopped 7 days before the first dose of study medication. This includes over-the-counter and prescription medication.
5. The patient has a long-term treatment with anticoagulants, e.g. warfarin, phenprocoumon.
6. The patient has a history of alcohol, analgesic or narcotic abuse.
7. The patient has a known hypersensitivity to NSAIDs, coxibs, analgesics, or sulfonamides, or a history of previous serious allergic drug reactions of any type, especially cutaneous reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.
8. The patient is considered to be clinically significantly volume-depleted, in the opinion of the investigator.
9. The patient has any known laboratory abnormality which, in the opinion of the Investigator, would contraindicate study participation, including AST (SGOT) or ALT (SGPT) > 1.5 times the upper limit of the reference range, or creatinine greater than 1.5 times the upper limit of the reference range.
10. The patient has inflammatory bowel disease (e.g. Crohn’s disease or ulcerative colitis), a chronic or acute renal or hepatic disorder (serum albumin < 25 g / l or Child Pugh score ³ 10), a significant coagulation defect, or any condition which, in the Investigator’s opinion, might preclude the use of an NSAID.
11. 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.
12. The patient has a history of coronary artery bypass graft (CABG) procedures.
13. The patient has a history or current presence of asthma or bronchospasm which require treatment with glucocorticoids (inhaled glucocorticoids are allowed). Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid, NSAIDs or coxibs.
14. The patient has a history of intolerance to opioids or has other contraindications for the planned standard PCA morphine therapy.
15. The patient has contraindications according to the local prescribing information of Parecoxib.
16. The patient has received any investigational medication within 30 days prior to administration of study medication or is scheduled to receive an investigational drug other than parecoxib during the course of this study.
17. The patient has been previously admitted to this study.
18. The patient has any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.
19. The patient has severe intraoperative complications resulting in intensive care unit (ICU) admission and mechanical ventilation to be expected for longer than 12 h.
20. The patient has severe intraoperative bleedings defined as receiving at least 5 units of RBCs during surgery until skin closure.
21. The patient has an operative time of 4 h or more duration.
22. Last dose of fentanyl was administered within 30 min before the end of surgery.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
The total cumulative amount of morphine administered (PCA and bolus / mg) in the 24 hours after the end of surgery (i.e., application of the last surgical stitch) is the primary endpoint.
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | Yes |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
This trial will be conducted in Germany only. End of Trial is defined as Last Subject Last Visit.
Premature termination of this clinical trial may occur because of a regulatory authority decision, change in opinion of the IRB/IEC, drug safety problems, or at the discretion of Pfizer. In addition, Pfizer retains the right to discontinue development of Parecxoib sodium at any time. |
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 18 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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