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Scintigraphic Assessment Following Klean-Prep® or Moviprep®

NCT00896246 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2009-05-12

No results posted yet for this study

Summary

This was a phase 1, open-label, randomized study, designed to assess the impact of Moviprep® or Klean-Prep® on gastrointestinal transit. It was performed in two parallel groups with Part A in two groups of four subjects preceding Part B, which was performed in two groups of 12 subjects. Subjects attended a pre-study medical within 28 days of dosing and a post-study medical 5-10 days after the final dose. Within both Part A and Part B, subjects were required to attend the clinical unit for 2 study periods. Part A consisted of a baseline period to determine individual reference times for gastrointestinal transit. Part B was the test period in which gastrointestinal transit following the administration of the test preparations was assessed.

Conditions

  • Gastric Emptying
  • Healthy

Interventions

DRUG

Klean-Prep®

Four litres of solution administered orally as a divided dose.

DRUG

Moviprep®

Two litres of solution administered orally as a divided dose

Sponsors & Collaborators

Principal Investigators

  • Hans-Jürgen Gruss, MD · Norgine

  • Philip Evans, MB ChB MRCS · Pharmaceutical Profiles Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2006-10-31
Completion
2006-11-30

Countries

  • United Kingdom

Study Locations

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Entities

Companies

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 NCT00896246 on ClinicalTrials.gov