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NCT00323817 Clinical Trial

To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00323817
Other study ID # 99010206E
Secondary ID
Status Completed
Phase Phase 2
First received May 8, 2006
Last updated May 26, 2015
Start date April 2006
Est. completion date October 2009

Study information
Verified date May 2015
Source Zeria Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of Z-338 in subjects with Functional Dyspepsia

Recruitment information / eligibility
Status Completed
Enrollment 282
Est. completion date October 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Subjects presenting diagnosis of FD as defined by the Rome II

- Subjects presenting postprandial fullness and/or Early satiety should be the most bothersome symptom

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Z-338

Locations
Country Name City State
Belgium Leuven University Leuven

Sponsors (1)
Lead Sponsor Collaborator
Zeria Pharmaceutical

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Global subject Outcome Assessment 12 month No
Secondary Individual symptom 12 month No
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