An exploratory, randomised, active-controlled, double-blind, double-dummy, parallel group pilot study to determine the ability of oxycodone/naloxone prolonged release tablets (OXN) to reduce the number of subjects developing symptoms of opioid induced constipation compared to morphine prolonged release tablets (MOR PR) in opioid naïve, non-constipated subjects with non malignant pain that require opioid treatment.
- Conditions
- Opioid induced constipationMedDRA version: 9.1Level: LLTClassification code 10021175Term: Iatrogenic constipation
- Registration Number
- EUCTR2007-005922-62-HU
- Lead Sponsor
- Mundipharma Research GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
1. Male or female subjects at least 18 years or older (females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded within 72 hours 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. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasoectomised partner).
2. Documented history of non malignant pain (e.g., Low Back Pain, Osteoarthritis, Neuropathic pain) that requires opioid therapy (20-40 mg oxycodone PR per day or 40 - 80 morphine PR per day) for a minimum of 4 weeks, because non-opioid therapy used previously did not result in considerable pain relief. This non-effectiveness of non-opioid therapy is to be documented for each subject. As neuropathic pain is a kind of pain that does not react very easily to opioid treatment, the ineffectiveness of the most up-to-date non-opioid treatment is to be included in the source documentation for these subjects. (Only for HU.)
3. Subjects must not have reported constipation within the last 3 months, and subjects must not have taken laxative medication in the last 3 months before the start of the study.
4. Subjects must not have received opioid containing medication in the last 6 months on a regular basis (i.e. prescribed medication or more than occasional self medication use for cough/cold etc).
5. In the investigator’s opinion the non opioid analgesic medication dose will remain stable during the double blind phase.
6. Subjects must be willing and able to participate in all aspects of the study, including use of medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing written, informed consent.
7. In the investigator’s opinion the subject’s non-analgesic concomitant medications, including those medications for the treatment of depression are thought to be stable, and will remain stable throughout the double-blind period of the study.
8. The subject agrees not to significantly alter their diet in any way that may affect bowel function during the course of the study.
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. Any history of hypersensitivity to oxycodone, naloxone, morphine, related products or other ingredients.
2. Any contraindication to bisacodyl and other ingredients
3. Active alcohol or drug abuse and/or history of opioid abuse.
4. Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (e.g. paralytic ileus), or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results.
5. Chronic or intermittent pain that results from Fibromyalgia, Rheumatoid Arthritis or Cancer.
6. Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (>3 times the upper limit of normal) or an abnormal total bilirubin and/or creatinine level(s) (outside of the reference range), gamma glutamyl transpeptidase (GGT or GGTP) =5 times the upper limit of normal.
7. Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the investigator’s opinion, may pose a risk of additional CNS depression with opioid study medication.
8. Subjects with uncontrolled seizures or convulsive disorder.
9. Subjects 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).
10. Surgery within 2 months prior to the start of the Screening Period, or planned surgery during the 4-week Double-blind Phase that may affect GI motility or pain.
11. Subjects presently taking, or who have taken, naloxone less than or equal to 30 days prior to the start of the Screening Period
12. Subjects with a history of recurrent diarrhea in the 3 months before the start of the screening period.
13. Subjects with any situation in which opioids are contraindicated, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, paralytic ileus
14. Subjects with myxoedema, hypothyroidism, Addison`s disease, increase of intracranial pressure.
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