Opioid-induced constipation
Conditions
Interventions
Product Name: Methylnaltrexone bromide for SC injection: 8 mg (0.4 mL, 20 mg/mL) in sterile prefilled syringes
Product Code: MOA-728
Pharmaceutical Form: Solution for i
Sponsors
Salix Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all postbaseline efficacy, safety, and health outcomes assessments. 2. If not surgically sterile, must agree to use a medically acceptable method of birth control or practice sexual abstinence for the duration of the study and for 15 days after the last dose of methylnaltrexone (unless female and postmenopausal, ie, > 12 months since the last menstrual period). 3. Is receiving opioids on a regular schedule, not just PRN or rescue doses, for the control of pain. 4. Has stable vital signs as determined by the investigator. 5. Has an anticipated continued need for treatment of OIC for the duration of participation in the study. 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 254 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 254
Exclusion criteria
Exclusion criteria: 1. Is participating in any other studies involving investigational products. 2. Has a known or suspected mechanical gastrointestinal obstruction; or a known/suspected lesion of the gastrointestinal tract that, in the opinion of the investigator, might be associated with an increased risk of gastrointestinal perforation. 3. Has clinically important active diverticular disease as determined by the investigator. 4. Has evidence of fecal impaction by physical examination or x-ray examination. 5. Has physical evidence of peritonitis. 6. Has a fecal ostomy. 7. Has known or suspected allergies to methylnaltrexone or other similar compounds (ie, naltrexone, naloxone). 8. Is pregnant and/or nursing. 9. Has any other clinically important abnormalities such that participation would put the subject at undue risk relative to the potential benefit of therapy as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to obtain additional safety data on SC methylnaltrexone administered as needed (PRN; but not more than every 24 hours) to subjects with advanced illness in a realistic end-of-life health care situation.;Secondary Objective: None; Primary end point(s): Safety evaluation will include the collection of adverse events and concomitant medications, vital signs, physical examination, laboratory assessments and calculation of the GFR. Efficacy evaluation: date and time of bowel movements will be collected. | — |
Countries
Belgium, Denmark, Finland, France, Germany, Italy, Portugal, Spain, Sweden, United Kingdom
Contacts
Public ContactJulie Matthews
TMC Pharma Services Ltd.
Outcome results
None listed