TLESR-impedance Study in Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to compare frequency and content of reflux episodes in patients with gastroesophageal reflux disease.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience

NCT01043185

Gastroesophageal Reflux Disease

COMPLETED PHASE2

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

NCT00813306

Reflux Episodes

COMPLETED PHASE1/PHASE2

Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients

NCT00394472

Gastroesophageal Reflux Disease (GERD)

COMPLETED PHASE2

AZD3355 Dose-escalation Study in Healthy Males

NCT00757419

Reflux Disease

COMPLETED PHASE1

Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms

NCT00703534

GERD Acid Reflux Disease Heartburn +1 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Reflux Episodes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

AZD3355

Group Type EXPERIMENTAL

AZD3355

Intervention Type DRUG

65 mg capsules, oral, 3 single doses

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

capsules, oral, 3 single doses

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD3355

65 mg capsules, oral, 3 single doses

Intervention Type DRUG

Placebo

capsules, oral, 3 single doses

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lesogaberan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Provision of written consent
* GERD patients, age 18-70 years, females must be postmenopausal or surgically sterilised
* 6 months history of GERD and incomplete response to PPI treatment

Exclusion Criteria

* Insufficient symptom burden of the reflux disease evaluated by questionnaires
* S-creatinine \>1.2 times upper limit of normal
* History of heart disease
* Prior surgery of the upper GI tract

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No