Prokinetics to alter the position of the gastric acid pocket in Gastro Esophageal Reflux Disease - Prokinetics and the acid pocket

• Conditions: gastro-esophageal reflux disease (GERD); MedDRA version: 9.1Level: LLTClassification code 10000479Term: Acid reflux (oesophageal); MedDRA version: 9.1Level: LLTClassification code 10017884Term: Gastrooesophageal reflux; MedDRA version: 9.1Level: LLTClassification code 10017885Term: Gastrooesophageal reflux disease; MedDRA version: 9.1Level: LLTClassification code 10038262Term: Reflux esophagitis; MedDRA version: 9.1Level: LLTClassification code 10020024Term: Hiatal hernia

• Registration Number: EUCTR2009-013080-19-NL
• Lead Sponsor: AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

GERD patients with a hiatal hernia
-18-65 years
-esophagitis and/or pH-metry with an acid exposure of > 4,5%
-hiatal hernia as seen on endoscopy or barium swallow of > 3 cm
GERD patients without a hiatal hernia
-18-65 years
-esophagitis and/or pH-metry with an acid exposure of > 4,5%
-no hiatal hernia or a hiatal hernia < 2 cm as seen on endoscopy or barium swallow

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-surgery of the gastrointestinal tract other then appendectomy
-use of medication that interfere with gastrointestinal motility
-inability to stop the use of proton pump inhibitors twice for one week
-participation in another study with exposure to radiation within the last year

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified