A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01043185
First received: December 22, 2009
Last updated: May 13, 2011
Last verified: May 2011
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Purpose
The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Disease |
Drug: AZD3355 Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Placebo Controlled, Randomised, Phase IIA Pharmacodynamic 4-way Cross-over Study to Estimate the Dose Response Relationship of AZD3355 on the Number of Reflux Episodes Assessed by Impedance/pH in Patients With GERD and a Partial Response to PPI Treatment |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Total Number of Reflux Episodes During 24 Hours [ Time Frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between ] [ Designated as safety issue: No ]Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)
Secondary Outcome Measures:
- Number of Acid Reflux Episodes [ Time Frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between ] [ Designated as safety issue: No ]Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH <4 (or a drop of at least 1 pH unit if pH is already <4) lasting more than 5 s.
- Number of Weakly Acidic Reflux Episodes [ Time Frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between ] [ Designated as safety issue: No ]Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0-6.5 lasting more than 5 s.
- Number of Weakly Alkaline Reflux Episodes [ Time Frame: Measured during 24 hours at 4 different visits with a 7-28 days interval between ] [ Designated as safety issue: No ]Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.
| Enrollment: | 27 |
| Study Start Date: | December 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
AZD3355 30 mg
|
Drug: AZD3355
30 mg orally in the morning and 30 mg in the evening for 1 day
|
|
Experimental: B
AZD3355 90 mg
|
Drug: AZD3355
90 mg orally in the morning and 90 mg in the evening for 1 day
|
|
Experimental: C
AZD3355 120 mg
|
Drug: AZD3355
120 mg orally in the morning and 120 mg in the evening for 1 day
|
|
Experimental: D
AZD3355 240 mg
|
Drug: AZD3355
240 mg orally in the morning and 240 mg in the evening for 1 day
|
|
Placebo Comparator: E
Placebo
|
Drug: placebo
Placebo capsules orally in the morning and placebo capsules in the evening for 1 day
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provide informed consent
- History of GERD with persistent symptoms despite treatment with PPI
- Otherwise normal physical health
Exclusion Criteria:
- History of GERD with symptoms that has not improved at all during treatment with PPI
- Prior surgery of the upper gastrointestinal tract
- History of significant heart disease, cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric or gastrointestinal disorders besides GERD
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043185
Locations
| United States, Oklahoma | |
| Research Site | |
| Oklahoma City, Oklahoma, United States | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Philip Miner | Oklahoma Foundation of Digestive Research |
| Study Director: | Debra G Silberg | AstraZeneca AB |
More Information
No publications provided
| Responsible Party: | MSD, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01043185 History of Changes |
| Other Study ID Numbers: | D9120C00032 |
| Study First Received: | December 22, 2009 |
| Results First Received: | April 8, 2011 |
| Last Updated: | May 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
GERD lesogaberan impedance pH |
pharmacokinetics safety tolerability |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013