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Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI

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ClinicalTrials.gov Identifier: NCT01005251
Recruitment Status : Completed
First Posted : October 30, 2009
Results First Posted : April 25, 2011
Last Update Posted : April 25, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
This study is being carried out to see whether AZD3355 is an effective treatment as an add-on to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another goal of the study is to examine which of the investigated doses of AZD3355 is optimal for treatment of these patients. This study will also measure levels of drug in the blood and see how well it is tolerated.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Heartburn Regurgitation Drug: lesogaberan (AZD3355) Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 661 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Experimental: 60 mg
PPI+lesogaberan (AZD3355) 60 mg bid
Drug: lesogaberan (AZD3355)
60 mg, oral, capsules, bid for 4 w
Experimental: 120 mg
PPI+lesogaberan (AZD3355) 120 mg bid
Drug: lesogaberan (AZD3355)
120 mg, oral, capsules, bid for 4 w
Experimental: 180 mg
PPI+lesogaberan (AZD3355) 180 mg bid
Drug: lesogaberan (AZD3355)
180 mg, oral, capsules, bid for 4 w
Experimental: 240 mg
PPI+lesogaberan (AZD3355) 240 mg bid
Drug: lesogaberan (AZD3355)
240 mg, oral, capsules, bid for 4 w
Placebo Comparator: Placebo
PPI+ Placebo
Drug: Placebo
oral,capsules, bid for 4 w



Primary Outcome Measures :
  1. Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation) [ Time Frame: The 7 days before randomisation (baseline) and during 26-30 days of 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 Symptom Questionnaire diary.

    (GERD = Gastroesophageal Reflux Disease)



Secondary Outcome Measures :
  1. Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms. [ Time Frame: The 7 days before randomisation (baseline) and during 26-30 days of 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 Symptom Questionnaire diary

    (GERD = Gastroesophageal Reflux Disease)




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Have at least 6 months history of GERD
  • Continuously treated during the last 4 weeks before enrolment with daily optimized unchanged PPI therapy for any GERD indication

Exclusion Criteria:

  • Patients that have not experienced any GERD symptom improvement at all during PPI treatment
  • Prior surgery of the upper gastrointestinal tract.
  • Subject who have any of the following conditions or diseases: Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005251


Locations
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Debra Silberg, MD AstraZeneca
Principal Investigator: Nicholas Shaheen, MD, MPH UNC Hospitals, 4141Chapel Hill, NC 27599 USA

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01005251     History of Changes
Other Study ID Numbers: D9120C00019
First Posted: October 30, 2009    Key Record Dates
Results First Posted: April 25, 2011
Last Update Posted: April 25, 2011
Last Verified: March 2011

Keywords provided by AstraZeneca:
GERD treatment
Acid and non-acid Reflux
Heartburn
Regurgitation
Add-on treatment to PPI

Additional relevant MeSH terms:
Gastroesophageal Reflux
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Lesogaberan
Gastrointestinal Agents
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs