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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01005251
First received: October 27, 2009
Last updated: March 29, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Gastroesophageal Reflux Disease
Heartburn
Regurgitation
Drug: lesogaberan (AZD3355)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ 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 Symptom Questionnaire diary.

    (GERD = Gastroesophageal Reflux Disease)



Secondary Outcome Measures:
  • 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 ] [ 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 Symptom Questionnaire diary

    (GERD = Gastroesophageal Reflux Disease)



Enrollment: 661
Study Start Date: October 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: 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
  More Information

No publications provided by AstraZeneca

Additional 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
Study First Received: October 27, 2009
Results First Received: February 23, 2011
Last Updated: March 29, 2011
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014