None listed
Conditions
Interventions
GROUP 1 Type of group
Patients in this group will be treated with ALVIMOPAN placebo twice a day for up to the end of the study (Approximately 18 months). All patients will receive a stool softener and rescue medications, which will be used according to clinical criteria.
Group name:GROUP 3 Type of group
Patients in this group will be treated with ALVIMOPAN 0.5 mg twice a day for 3 days. After this the dose is increased to 1 mg, 2 times a day until the end of the study (Approximately 18 months). All patients will receive a stool softener and rescue medications, which will be used according to clinical criteria.
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient has completed a GSK study with alvimopan in OBD in oncological pain. 2. The patient takes chronic opioid treatment for cancer pain. 3. The patient meets the criteria defined in the protocol for OBD in the original study and continues to require therapy or care for OBD. 4. The patient understands the procedures, agrees to participate in the study and has signed the informed consent form. 5. The patient can fill in the questionnaires on paper. 6. If the patient is female: a) Is not potentially fertile or b) Is potentially fertile, presents a negative pregnancy test and agrees to use an acceptable contraceptive method.
Exclusion criteria
Exclusion criteria: 1. The patient is pregnant or breast-feeding, or plans to become pregnant. 2. The patient has participated in another clinical trial with a drug, device or procedure under investigation in the previous 30 days. 3. The patient can not eat or drink. 4. The patient takes opioids for the treatment of drug addiction. 5. The patient takes opioids that are combined agonists / antagonists or partial agonists. 6. The patient can not or will not stop using emollient laxatives or laxatives of any type and formulation. 7. The patient has severe constipation that has not been adequately controlled so that the patient is at immediate risk of serious complications. 8. Patients with GI or pelvic disorders that are known to affect intestinal transit, produce GI obstruction or contribute to intestinal dysfunction. 9. The patient currently takes vinca alkaloids or plans to take them during the study. 10. Patients who have intestinal dysfunction that is mainly due to causes other than chronic opioid use. 11. Patients with chronic fecal incontinence. 12. Patients who are taking antidiarrheals, who have diarrhea or loose stools in the previous 2 weeks. 13. Patients with active viral hepatitis 14. Patients who have received previous radiation therapy that has produced chronic enteritis by radiation or documented radiation stenosis. 15. Subjects that have significant laboratory alterations. 16. The patient has a history of alcohol and / or drug abuse in the previous 2 years. 17. The patient is taking a concomitant medication or has some other known pathology or finding in the physical examination that could contraindicate their participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Detection of adverse events: Patient report and clinical evaluation. Measure:Incidence of adverse effects. Timepoints:Days 1, 29, 57, weeks 16, 24, 32, 40, 48, 56 and so on consecutively until the study is discontinued. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Physical evaluation Laboratory tests: Biochemistry panel, blood panel, pregnancy tests. Scale of graduated pain of 11 points. Measure: Safety of treatment: Incidence of toxicity limited to treatment (clinical and laboratory events). Changes in pain intensity score. Changes in the morphine equivalents of the opioids used. Changes in laboratory analysis. Timepoints:Physical evaluation: Days 1, 29, 57, weeks 16, 24, 32, 40, 48, 56 and so on consecutively until the study is discontinued. Biochemical and haematological panels: Days 1, 29, 57, weeks 16, 24, 32, 40, 48, 56 and so on consecutively until the study is discontinued. Pregnancy test: Before the study and at the end of this. Numeric scale of pain: Days 1, 29, 57, weeks 16, 24, 32, 40, 48, 56 and so on consecutively until the study is discontinued. ; Outcome name:Likert scale of 7 points. Measure:Efficacy of the treatment: Answers on the Overall improvement of the OBD. Proportion of subjects reporting that their OBD is moderately improved or substantially improved. Proportion of subjects reporting yes, that they would use their study again. Changes in the average number of days per week that stool softeners and rescue laxatives are used. Timepoints:Days 29, 57, weeks 16, 24, 32, 40, 48, 56 and so on consecutively until the study is discontinued. ; Outcome name:Quality of life survey PAC-QOL. Measure:Health results. Timepoints:Day 57, weeks 16, 24, 32, 40, 48, 56 and so on consecutively until the study is discontinued. ; Outcome name:Concentration of alvimopan and its main metabolite (ADL 08-0011) in peripheral blood samples. Measure:Pharmacokinetics. Timepoints:Day 29, weeks 16, 24, 32, 40, 48, 56. ; Outcome name:Functional status score of Kamofsky. Measure:Functional status. Timepoints:Days 29, 57, weeks 16, 24, 32, 40, 48, 56 and so on consecutively until the study is discontinued. | — |
Countries
Argentina, Australia, Canada, China, Czech Republic, Finland, France, India, Korea South, New Zealand, Pakistan, Philippines, Poland, Portugal, Russian Federation, Spain, United Kindgdom, United States
Outcome results
None listed