Other Clinical Trial - A a Single Dose Efficacy Study in NCT00401362

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

To test the effectiveness of MNTX in advanced illness subjects.

To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.

Recruitment information / eligibility
Status	Completed
Enrollment	154
Est. completion date	February 2005
Est. primary completion date	February 2005
Accepts healthy volunteers	No
Gender	All
Age group	18 Years and older
Eligibility	Inclusion Criteria: 1. Advanced medical illness with a life expectancy of 1 to 6 months 2. No clinically significant laxation within 48 hours prior to the first dose of study drug 3. On stable opioid and laxative regimen for a least 3 days prior to treatment 4. Age greater than 18years 5. Females of child-bearing age must have a negative pregnancy test. Exclusion Criteria: 1. Females who are pregnant or nursing. 2. Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC 3. Any disease process suggestive of gastrointestinal obstruction 4. Fecal ostomy.

Drug:
• SC Methylnaltrexone
Dose 1
• SC Placebo

• SC Methylnaltrexone
Dose 2

Locations
Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc.	Tarrytown	New York

Sponsors *(2)*
Lead Sponsor	Collaborator
Bausch Health Americas, Inc.	Pfizer

United States,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of SC MNTX compared with placebo in inducing laxation	The primary objective is to determine the efficacy of SC MNTX administered as a single dose, dose 1 and dose 2 compared with placebo in inducing laxation in 4 hours in patients with advanced medical illness and OIC who are poorly responsive to laxatives.	29 days