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14473 - D9126C00001 Proof of Principle Study - Effect of AZD2066 on Transient Lower Esophageal Sphincter Relaxations

NCT00813306 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-12-07

No results posted yet for this study

Summary

The purpose of the study is to assess the safety and tolerability of AZD2066 and to explore the effect of a single dose of AZD2066 on the function of the cardia (the opening between the stomach and the esophagus) compared to placebo (not containing any medical substance) in healthy volunteers.

Conditions

  • Reflux Episodes

Interventions

DRUG

AZD2066

13 mg oral solution, 1 single dose

DRUG

Placebo

Oral solution, 1 single dose

DRUG

AZD2066

Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose

DRUG

AZD2066

Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose

DRUG

Placebo

Oral solution, 1 single dose

Sponsors & Collaborators

Principal Investigators

  • Marie Sundin · AstraZeneca R&D, Mölndal, Sweden

  • Guy E Boeckxstaens, MD, PhD · Motiliteitscentrum (C2-310)Department of Gastroenterology,Academic Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Completion
2009-11-30

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00813306 on ClinicalTrials.gov