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The Effects of Z-338 in Subjects With and Without Functional Dyspepsia

Z

Zeria Pharmaceutical

Status and phase

Completed
Phase 2

Conditions

Dyspepsia

Treatments

Drug: Z-338

Study type

Interventional

Funder types

Industry

Identifiers

NCT00298194
99010205E

Details and patient eligibility

About

To assess in subjects with and without functional dyspepsia the effects of Z-338 on:

  1. Type and severity of symptoms a standardized nutrient challenge
  2. The gastric nutrient distribution and gastric emptying of a standardized nutrient challenge
  3. The association of the above with the manifestations of symptoms and symptom pattern

Enrollment

52 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  1. Subjects with functional dyspepsia Positive documented diagnosis of FD via RomeII criteria and three or more moderate symptoms of Gastrointestinal Score
  2. Subjects with no history of functional dyspepsia Clinical assessment, physical examination and laboratory testing without evidence for relevant abnormality.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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