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Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00394472
First received: October 31, 2006
Last updated: February 14, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients with an incomplete response to PPI treatment.
| Condition | Intervention | Phase |
|---|---|---|
| Gastroesophageal Reflux Disease (GERD) | Drug: AZD3355 | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Placebo Controlled, Phase IIA Study to Assess the Effect on Gastroesophageal Reflux Disease (GERD) Symptoms, Pharmacokinetics, Safety and Tolerability of 4 Weeks Treatment With AZD3355 65 mg Bid as add-on Treatment to a Proton Pump Inhibitor (PPI) in Patients With an Incomplete Response to PPI. |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment [ Time Frame: Twice daily during the last seven days on treatment ]Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary
Secondary Outcome Measures:
- Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule [ Time Frame: An interval of one to two hours after the first intake of AZD3355 65 mg capsule ]
| Enrollment: | 244 |
| Study Start Date: | November 2006 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: AZD3355
Other Name: Lesogaberan
Eligibility| Ages Eligible for Study: | 17 Years to 70 Years (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provision of written informed consent
- At least 6 months history of Gastroesophageal reflux disease (GERD) symptoms
- Continuous treatment with Proton Pump Inhibitor (PPI)
- Ability to read and write
Exclusion Criteria:
- Prior surgery of the upper gastrointestinal (GI) tract
- History of clinically significant diseases other than GERD
- Need for concomitant medication with drugs that may influence gastrointestinal symptoms
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394472
Show 38 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394472
Show 38 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Göran Hasselgren, MD | AstraZeneca |
| Principal Investigator: | Guy Boeckxstaens, MD | Academisch Medisch Centrum Universiteit van Amsterdam |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00394472 History of Changes |
| Other Study ID Numbers: |
D9120C00011 EUDRACT No 2006-003541-16 |
| Study First Received: | October 31, 2006 |
| Results First Received: | August 11, 2011 |
| Last Updated: | February 14, 2013 |
Keywords provided by AstraZeneca:
|
Heartburn Patient reported symptoms Proton pump inhibitor |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Proton Pump Inhibitors Lesogaberan |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents GABA-A Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 21, 2017