An exploratory, randomised, parallel-group, open-label, multicentre study to assess the post-operative management of moderate to severe pain in patients who underwent laparoscopic cholecystectomy, receiving oxycodone hydrochloride i.v. within 12 - 24 hours after surgery at first and then oxycodone / naloxone prolonged release tablets compared to patients receiving piritramide infusions.
- Conditions
- post-operative management of moderate to severe pain in patients who underwent laparoscopic cholecystectomyMedDRA version: 9.1Level: LLTClassification code 10054711Term: Postoperative pain
- Registration Number
- EUCTR2008-003566-26-DE
- Lead Sponsor
- Mundipharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Male or female patients at least 18 years or older.
2. Females of child-bearing age and females less than one year post-menopausal must have a negative serum pregnancy test recorded in the Screening Phase prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study (highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some hormonal intrauterine device, sexual abstinence or vasectomised partner).
3.Patients designated for laparoscopic cholecystectomy and suffering postoperatively from moderate to severe pain or from continuously increasing pain consecutively leading to moderate to severe pain. The Investigator expects that the pain will continue for a minimum of 2 days. Patients are eligible for randomization if one of the following criteria is met:
a)Patient actively reports that she/he suffers from moderate to severe pain and rates a pain on a NRS = 4.
b)Patient actively reports that she/he suffers from an increasing pain and the Investigator expects that this pain will lead to moderate to severe pain and requires a treatment with a WHO step III opioid.
c)If not actively reporting, the responsive patient will be asked in the recovery area to rate the current pain on the NRS. If the pain is rated with NRS = 4, the patient will be randomized. If the pain is rated with NRS < 4, the patient will be asked whether she/he suffers from an increasing pain which is expected by the Investigator to lead to moderate to severe pain and to require a treatment with a WHO step III opioid.
4. Patients willing and able to participate in all aspects of the study, including use of oral or intravenous infusion medication, completion of patients’ evaluations (questionnaires), attending scheduled clinic visits and completion of all examinations, completion of telephone follow-up contact, and compliance with protocol requirements as evidenced by providing written, informed consent.
5. Patients willing to stop their laxative intake prior to study participation.
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
1. Females who are pregnant (positive beta-hCG test), lactating or not willing to accept effective methods of contraception.
2. Patients with any history of hypersensitivity to oxycodone, naloxone, piritramide, bisacodyl and further ingredients of the study medications.
3. Patients with any contraindication to oxycodone, naloxone, piritramide, bisacodyl and further ingredients of the study medications.
4. Patients with any consuming disease.
5. Patients presently taking or having taken Monoamine Oxidase Inhibitors ? 14 days prior to the start of the Screening Period.
6. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
7. Patients with evidence of impaired liver and kidney function upon entry into the study defined as aspartate aminotransferase (ASAT; SGOT), alanine aminotransferase (ALAT; SGPT), or alkaline phosphatase levels > 3 times the upper limit of normal; gamma glutamyl transpeptidase (GGT) ? 5 times the upper limit of normal; total bilirubin level outside of the reference range; and/or creatinine level outside of the reference range or > 2 mg/dL, or in the Investigator´s opinion, liver and/or kidney impairment to the extent that the patient should not participate in this study.
8. Patients with evidence of significant structural abnormalities of the gastrointestinal tract or any diseases/conditions that affect bowel transit.
9. Patients with evidence of any clinically unstable disease following the Investigator’s review of the medical history, physical examination and clinical laboratory tests, with the exception of those parameters which are resulting from the underlying basic disease, that would place the patient at risk upon exposure to the study medications or that may confound the analysis and/or interpretation of the study results.
10. Patients with an active alcohol or drug abuse and/or history of opioid abuse.
11. Patients receiving opioid substitution therapy for opioid addiction (e.g., methadone or buprenorphine).
12. Patients who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as the start of the Screening Period).
13. Patients who are committed by authorities or jurisdictionally to an institution according to the German Medicines Act (AMG) para 40 clause 1 p. 3 no. 4.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method