Open-Label Treatment Extension of Protocol MNTX 302

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01367613
First received: May 27, 2011
Last updated: July 18, 2011
Last verified: July 2011

May 27, 2011
July 18, 2011
March 2004
January 2006   (final data collection date for primary outcome measure)
Number of patients with adverse events [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To provide access to treatment with MNTX, administered SC, to patients who completed Progenics' Protocol MNTX 302
Same as current
Complete list of historical versions of study NCT01367613 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Open-Label Treatment Extension of Protocol MNTX 302
A Three-Month Open-Label Treatment Extension of Protocol MNTX 302

This is a 3 month open-label extension study that allows patients who completed Protocol MNTX 302 to receive SC MNTX.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Terminal Illness
Drug: SC Methylnaltrexone
Experimental: Arm 1
Intervention: Drug: SC Methylnaltrexone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
January 2006
January 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Must be enrolled and consented within 28 days of the end of study visit of MNTX 302 and 14 or more days from first dose of study drug in MNTX 302.
  2. Negative pregnancy test
  3. Stable vital signs

Exclusion Criteria:

  1. Women who are pregnant and/or nursing
  2. Received any investigational product, other than MNTX, in the past 30 days
  3. Evidence of fecal impaction
  4. Clinically significant active diverticular disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01367613
MNTX 302EXT
Yes
Tage Ramakrishna, M.D., Progenics Pharmaceuticals, Inc.
Salix Pharmaceuticals
Not Provided
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
Salix Pharmaceuticals
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP