Reflux Episodes Clinical Trial
Official title:
A Double-blind, Randomized, Placebo-controlled, Single-centre Phase I Pharmacodynamic Cross-over Study to Assess the Effect of a Single Dose of AZD2066 Oral Solution in Comparison to Placebo on Transient Lower Esophageal Sphincter Relaxations (TLESRs) in Healthy Subjects
Verified date | December 2010 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Medicines Evaluation Board (MEB) |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | November 2009 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Provision of written consent prior to any study specific procedures. - Healthy subjects, age 18-45 years inclusive. Females must be of no childbearing potential or must use a highly effective contraceptive method. - Clinically normal physical findings and laboratory values at the time of pre-entry visit, as judged by the investigator. Exclusion Criteria: - Clinically significant illness within the 2 weeks prior to the first dose of the investigational product, including a suspected/manifested infection according to WHO risk categories 2, 3 or 4, as judged by the investigator. - A measured LES pressure of < 5mm Hg. - History of previous or ongoing psychiatric disease/condition. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Netherlands | Research site | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Manometry | 3.45 hours each study period | No | |
Secondary | pH | 3.45 hours each study period | No | |
Secondary | Impedance | 3.45 hours each study period | No | |
Secondary | Pharmacokinetic variables | 3.45 hours each study period | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00743444 -
TLESR-impedance Study in Patients
|
Phase 2 |