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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| Tracking Information | |||||||||
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| First Received Date ICMJE | October 31, 2006 | ||||||||
| Last Updated Date | February 14, 2013 | ||||||||
| Start Date ICMJE | November 2006 | ||||||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] 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 |
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| Original Primary Outcome Measures ICMJE |
To estimate the effect of symptom improvement on Patient Reported symptoms | ||||||||
| Change History | Complete list of historical versions of study NCT00394472 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients | ||||||||
| Official Title ICMJE | 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. | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Gastroesophageal Reflux Disease (GERD) | ||||||||
| Intervention ICMJE | Drug: AZD3355
Other Name: Lesogaberan |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Boeckxstaens GE, Beaumont H, Hatlebakk JG, Silberg DG, Björck K, Karlsson M, Denison H. A novel reflux inhibitor lesogaberan (AZD3355) as add-on treatment in patients with GORD with persistent reflux symptoms despite proton pump inhibitor therapy: a randomised placebo-controlled trial. Gut. 2011 Sep;60(9):1182-8. Epub 2011 Mar 14. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 244 | ||||||||
| Completion Date | June 2007 | ||||||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 17 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Australia, Belgium, France, Germany, Hungary, Netherlands, Norway, Romania | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00394472 | ||||||||
| Other Study ID Numbers ICMJE | D9120C00011, EUDRACT No 2006-003541-16 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | AstraZeneca | ||||||||
| Study Sponsor ICMJE | AstraZeneca | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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