Clinical trial NCT01005251: Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroesophageal Reflux Disease
Heartburn
Regurgitation
Keywords: GERD treatment
Acid and non-acid Reflux
Heartburn
Regurgitation
Add-on treatment to PPI
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-10-30
Enrollment: 661
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: The 7 days before randomisation (baseline) and during 26-30 days of treatment
Secondary outcomes:
measure: Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.
timeFrame: The 7 days before randomisation (baseline) and during 26-30 days of treatment
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
Study officials:
affiliation: AstraZeneca
name: Debra Silberg, MD
role: STUDY_DIRECTOR
affiliation: UNC Hospitals, 4141Chapel Hill, NC 27599 USA
name: Nicholas Shaheen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shaheen NJ, Denison H, Bjorck K, Silberg DG. Esophageal mucosal breaks in gastroesophageal reflux disease partially responsive to proton pump inhibitor therapy. Am J Gastroenterol. 2013 Apr;108(4):529-34. doi: 10.1038/ajg.2012.447. Epub 2013 Jan 15.
citation: Shaheen NJ, Denison H, Bjorck K, Karlsson M, Silberg DG. Efficacy and safety of lesogaberan in gastro-oesophageal reflux disease: a randomised controlled trial. Gut. 2013 Sep;62(9):1248-55. doi: 10.1136/gutjnl-2012-302737. Epub 2012 Jun 23.