A randomized, double-blind, parallel-group, multicenter study to demonstrate improvement in symptoms of constipation in subjects with non-malignant pain taking oxycodone equivalent of >= 20 mg/day and <= 50 mg/day as oxycodone / naloxone prolonged release compared to subjects taking oxycodone prolonged release tablets alone.

Mundipharma Research GmbH & Co. KG0 个研究点目标入组 600 人开始时间: 2006年11月24日最近更新: 2012年4月18日

适应症

试验速览

暂无简介。

•1. Male or female subjects at least 18 years or older
•2. Female subjects less than one year post-menopausal must have a negative serum pregnancy test recorded 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 consitently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasoectomised partner.
•3. Moderate to severe chronic nonmalignant pain that requires around-the-clock opioid therapy (oxycodone equivalent of >= 20 mg/day and <= 50 mg/day).
•4. Subjects who require continuation of daily opioid treatment and are likely to benefit from WHO step III opioid therapy for the duration of the study.
•5. Subjects must be willing to discontinue their current opioid analgesic routine.
•6. Subjects must report constipation caused or aggravated by opioids.
•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 ß-hCG test) or lactating.
•2. Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract (e.g., bowel obstruction, strictures) or any diseases/conditions that affect bowel transit (e.g., ileus, hypothyroidism).
•3. Subjects with cancer associated pain.
•4. Active alcohol or drug abuse and/or history of opioid abuse.
•5. Subjects with Rheumatoid Arthritis (RA).
•6. Subjects with evidence of clinically unstable disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that, in the investigator’s opinion, preclude entry into the study.
•7. Subjects who have required treatment for the diagnosis of irritable bowel syndrome (IBS)
•8. Subjects receiving opioid substitution for opioid addiction (e.g., methadone or buprenorphine)

发起方