Esophageal hypersensitivity study in healthy volunteers
Study identifier:D9127C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2008-000313-30
CTIS identifier:N/A
Study Complete
Official Title
A phase I, two centre, double-blind, randomized, cross-over study to evaluate AZD1386 in single doses of 30 mg and 95 mg compared to placebo in a multimodal experimental pain model on esophageal sensitivity and development of sensitization in healthy male volunteers
Medical condition
Pain
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1386, Placebo
Sex
Male
Actual Enrollment
45
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Jun 2008
Primary Completion Date: -
Study Completion Date: 01 Jul 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 30 mg, oral, single dose | Drug: AZD1386 oral, single dose |
| Experimental: 2 95 mg, oral, single dose | Drug: AZD1386 oral, single dose |
| Placebo Comparator: 3 Oral solution, single dose | Drug: Placebo Oral solution, single dose |
Contacts
Investigators
Principal Investigator
Marie Sundin
AstraZeneca R&D, Mölndal, Sweden
