Randomized, Double-Blind Study of the morphine-sparing efficacy and safety of Parecoxib sodium 40 mg i.v. followed by 20 mg i.v. every 12 hours in the treatment of pain following radical prostatectomy

• Register: EUCTR
• Last refreshed on: 17 December 2012
• Main ID: EUCTR2005-006026-28-DE
• Date of registration: 07/06/2006
• Prospective Registration: Yes
• Primary sponsor: Pfizer Pharma GmbH
• Public title: Randomized, Double-Blind Study of the morphine-sparing efficacy and safety of Parecoxib sodium 40 mg i.v. followed by 20 mg i.v. every 12 hours in the treatment of pain following radical prostatectomy
• Scientific title: Randomized, Double-Blind Study of the morphine-sparing efficacy and safety of Parecoxib sodium 40 mg i.v. followed by 20 mg i.v. every 12 hours in the treatment of pain following radical prostatectomy
• Date of first enrolment: 25/09/2006
• Target sample size: 152
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-006026-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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. Th

Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

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.
MedDRA version: 8.1 Level: LLT Classification code 10054711 Term: Postoperative pain

Intervention(s)

Trade Name: Dynastat 20 mg
Product Code: Parecoxib
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: Parecoxib sodium
CAS Number: 197502-82-2
Current Sponsor code: Parecoxib sodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Trade Name: Dynastat 40 mg
Product Code: Parecoxib
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: Parecoxib sodium
CAS Number: 197502-82-2
Current Sponsor code: Parecoxib sodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Trade Name: Dynastat 40 mg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Parecoxib (as parecoxib sodium)
CAS Number: 197502-82-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

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.

Secondary Objective: 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.

Main Objective: 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.

Secondary ID(s)

A3481066