Moderate to severe non-malignant pain that requires around the clock opioid therapy and also have constipation secondary to opioid treatment. MedDRA version: 8.1 Level: LLT Classification code 10049475 Term: Chronic pain
Conditions
Interventions
Product Name: Oxycodone/Naloxone prolonged release tablets 40/20 mg
Product Code: OXN 40/20
Pharmaceutical Form: Prolonged-release tablet
INN or Propose
Sponsors
Mundipharma Research GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 consistently and correctly such as sterilization, 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate that subjects with moderate to severe non-malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation as measured by the bowel function index (BFI) compared to subjects taking oxycodone prolonged release tablets alone; Secondary Objective: The secondary objectives are: •To demonstrate that subjects taking OXN have improvement in symptoms of constipation as measured by the Patient Assessment of Opioid Induced Constipation summary score (PACOI; the mean of the summary scores from the rectal and stool subscales of the PAC-SYM) than subjects taking OXY tablets alone. •To compare the subjects’ overall opinion of their improvement with treatment over the course of the Double-blind Phase following treatment with OXN compared with OXY as measured by the Patient Global Impression of Change (PGIC). •To estimate the subjects’ Average Pain over the last 24 Hours assessed at each double-blind study visit during treatment with OXN compared with OXY as measured by the Pain Intensity Scale. ; Primary end point(s): - A subject’s Bowel Function Index (BFI) score will be the mean of the following items (assessed at each visit): - Ease of defecation (numerical analogue scale [NAS], 0=easy/no difficulty; 100=severe difficulty) - Feeling of incomplete bowel evacuation (NAS, 0=not at all, 100=very strong). - Personal judgment of constipation (NAS, 0=not at all, 100=very strong). Each of the above questions refers to the last 7 days for the subject | — |
Countries
Czech Republic, Germany, Italy, Spain, United Kingdom
Outcome results
None listed