A Phase IIB, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Delivery Guidelines for the Treatment of Opioid-Induced Intestinal Dysfunction in Patients with Oncologic Pai
- Conditions
- -K590 ConstipationConstipationK590
- Registration Number
- PER-070-05
- Lead Sponsor
- GLAXOSMITHKLINE PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Detection of adverse events: Patient report and clinical evaluation.<br><br>Measure:Incidence of adverse effects.<br>Timepoints:Days 1, 29, 57, weeks 16, 24, 32, 40, 48, 56 and so on consecutively until the study is discontinued.<br>
- Secondary Outcome Measures
Name Time Method