Scintigraphic Assessment Following Klean-Prep® or Moviprep®
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|ClinicalTrials.gov Identifier: NCT00896246|
Recruitment Status : Completed
First Posted : May 11, 2009
Last Update Posted : May 12, 2009
|Condition or disease||Intervention/treatment||Phase|
|Gastric Emptying Healthy||Drug: Klean-Prep® Drug: Moviprep®||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Scintigraphic Assessment of Gastrointestinal Transit Following Administration of Klean-Prep® (4L) or Moviprep® (2L) to Healthy Volunteers.|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||November 2006|
Active Comparator: Klean-Prep®
1 x gelatin capsule containing not more than 1 MBq 111In radiolabelled ion exchange resin plus Klean-Prep® (4 L) containing 99mTc-DTPA administered as a divided dose.
Four litres of solution administered orally as a divided dose.
1 x gelatin capsule containing not more than 1 MBq 111In radiolabelled ion exchange resin plus Moviprep® (2 L) containing radiolabelled 99mTc-DTPA administered as a divided dose.
Two litres of solution administered orally as a divided dose
- To assess the impact of Moviprep® and Klean-Prep® on time of colonic transit of the contents of the colon in comparison to baseline [ Time Frame: 2-4 days ]
- To assess the gastrointestinal transit of Moviprep® and Klean-Prep® in comparison to baseline [ Time Frame: 2-4 days ]
- To determine gastric emptying of Moviprep® and Klean-Prep® [ Time Frame: 2-4 days ]
- To collect information about stool weight, visual characteristics and distribution of the radiolabel [ Time Frame: 2-4 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896246
|Pharmaceutical Profiles Ltd|
|Nottingham, United Kingdom, NG11 6JS|
|Study Director:||Hans-Jürgen Gruss, MD||Norgine|
|Principal Investigator:||Philip Evans, MB ChB MRCS||Pharmaceutical Profiles Ltd|