None listed
Conditions
Interventions
GROUP 1 Type of group
Patients in this group will be treated with ALVIMOPAN placebo 2 times a day for 3 weeks
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 completing 3 weeks of therapy.
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject is a male or female 18 years or older at the time of the screening visit. 2. Subject has a minimum life expectancy equal or more than 3 months at the time of the screening visit. 3. Subject who has cancer or is in remission from a recent cancer, and is taking opioid therapy for continued intractable pain. 4. Subject meets the protocol-definition of opioid-induced bowel dysfimction. 5. Subject understands the procedures, agrees to participate in the study, and has signed and dated the informed consent. 6. Subject is capable of completing the Daily Diary. 7. Subject is female and is currently either of: a. non-childbearing potential or b. With child-bearing potential, has a negative serum B-hCG pregnancy test at the screening visit. 8. Subject is ambulatory to the extent that he/she is capable of voluntary laxation.
Exclusion criteria
Exclusion criteria: 1. Subject is pregnant or lactating, or planning to become pregnant during the study. 2. Subject has participated in another trial with an investigational drug, device or procedure within 30 days prior to the Screening Visit. 3. Subject is unable to eat or drink. 4. Subject is taking opioids for the management of drug addiction. 5. Subject is taking any mixed agonist/antagonist opioid analgesics. 6. Subject is unable or unwilling to discontinue the use of and/or refrain from using stool softeners and laxatives. 7. Subject has severe constipation that has not been appropriately managed. 8. Subject with GI or pelvic disorders known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfiinction. 9. Subject has symptomatic primary or secondary brain tumor. 10. Subject is currently taking vinca alkaloids or plans to take vinca alkaloids during the study. 11. Subject, who in the investigators opinion, has bowel dysfiinction that is predominantly resulting from causes other than the chronic use of opioids. 12. Concomitant medications with known attribution to constipation are allowed. 13. Subject with chronic fecal incontinehce. 14. Subject is taking antidiarrheals, has an incidence of diarrhea or loose stools in the 2 weeks prior to the Screening Visit or a history of intermittent diarrhea, loose stools or irritable bowel syndrome (IBS) symptoms which are consistent with the Rome II Criteria. 15. Subject, who in the investigators opinion, has an uncontroUed systemic disease. 16. Subject has undergone prior radiation therapy that resulted in documented chronic radiation enteritis or radiation stricture. 17. Subject has clinically significant laboratory abnormalities. 18. Subject has a history of alcohol and/or substance abuse within the past 2 years. 19. Subject has any other known condition or physical examination finding prior to Randomization, which could contraindicate participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation during visits. Measure:Primary efficacy: Weekly changes in complete spontaneous bowel movements. Timepoints:Days 1, 8 and 22. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:7-point Likert scale. Subjective evaluation of the patient during clinical visits. PAC-SYM questionnaire. Number of days that rescue laxatives were required. Measure:Secondary efficacy of the treatment. Timepoints:Days 8, 22. PAC-SYM questionnaire: Days 1, 8 and 22. ; Outcome name:1) Incidence of adverse events, incidence of toxicities that limit treatment, changes in morphine dose: Clinical evaluation. 2) Opioid Withdrawal Symptoms: Himmelsbach modified scale. 3) Serum chemistry, blood tests, pregnancy test. Measure:Safety of the treatment Incidence of adverse events. Incidence of toxicities that limit the treatment. Changes in the intensity of pain. Changes in the dose of morphine. Symptoms of opioid withdrawal. Changes in laboratory analytes. Timepoints:1) Clinical evaluation: At the time of starting the treatment and on days 1, 8 and 22. 2) Modified scale of Himmelsbach: At the time of starting the treatment and on days 1, 8 and 22. 3) Laboratory tests: At the time of starting the treatment and on day 22. | — |
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