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Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum

Fecal Incontinence Clinical Trial

Official title:
Proof of Concept Study in Healthy Volunteers to Investigate the Safety and Response to a Single Dose of 10mg Methoxamine (NRL001) Applied Locally Using a Suppository to the Anal Canal or Rectum

Clinical Trial Summary

Study to assess the effects of 10mg NRL001 on mean anal resting pressure (MARP) when administered as a slow release suppository applied to the anal canal or rectum. In addition, the pharmacokinetics of NRL001 in plasma, adverse events, and any changes in heart rate or blood pressure were to be assessed.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00893607
Study type Interventional
Source Norgine
Contact
Status Completed
Phase Phase 1
Start date April 2007
Completion date December 2007
View Details
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