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

NCT00893607 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2009-05-06

No results posted yet for this study

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.

Conditions

  • Fecal Incontinence

Interventions

DRUG

NRL001

10mg NRL001 was administered as a slow release suppository

Sponsors & Collaborators

Principal Investigators

  • John H Scholefield · University Hospital - Queens Medical Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2007-08-31
Completion
2007-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00893607 on ClinicalTrials.gov