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Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00394472
Recruitment Status : Completed
First Posted : November 1, 2006
Results First Posted : March 18, 2013
Last Update Posted : March 18, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE October 31, 2006
First Posted Date  ICMJE November 1, 2006
Results First Submitted Date  ICMJE August 11, 2011
Results First Posted Date  ICMJE March 18, 2013
Last Update Posted Date March 18, 2013
Study Start Date  ICMJE November 2006
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2006)
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
 (submitted: February 14, 2013)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2006)
  • To estimate the effect with respect to consumption of antacids
  • Assess the PK profile
  • Assess safety and tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux Disease (GERD)
Intervention  ICMJE Drug: AZD3355
Other Name: Lesogaberan
Study Arms  ICMJE 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. doi: 10.1136/gut.2010.235630. Epub 2011 Mar 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2013)
244
Original Enrollment  ICMJE
 (submitted: October 31, 2006)
400
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   France,   Germany,   Hungary,   Netherlands,   Norway,   Romania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00394472
Other Study ID Numbers  ICMJE D9120C00011
EUDRACT No 2006-003541-16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Göran Hasselgren, MD AstraZeneca
Principal Investigator: Guy Boeckxstaens, MD Academisch Medisch Centrum Universiteit van Amsterdam
PRS Account AstraZeneca
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP