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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

Primary Purpose

Gastroesophageal Reflux Disease, Heartburn, Regurgitation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lesogaberan (AZD3355)
lesogaberan (AZD3355)
lesogaberan (AZD3355)
lesogaberan (AZD3355)
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD treatment, Acid and non-acid Reflux, Heartburn, Regurgitation, Add-on treatment to PPI

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

60 mg

120 mg

180 mg

240 mg

Placebo

Arm Description

PPI+lesogaberan (AZD3355) 60 mg bid

PPI+lesogaberan (AZD3355) 120 mg bid

PPI+lesogaberan (AZD3355) 180 mg bid

PPI+lesogaberan (AZD3355) 240 mg bid

PPI+ Placebo

Outcomes

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)
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.
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)

Full Information

First Posted
October 27, 2009
Last Updated
March 29, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01005251
Brief Title
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

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Heartburn, Regurgitation
Keywords
GERD treatment, Acid and non-acid Reflux, Heartburn, Regurgitation, Add-on treatment to PPI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
661 (Actual)

8. Arms, Groups, and Interventions

Arm Title
60 mg
Arm Type
Experimental
Arm Description
PPI+lesogaberan (AZD3355) 60 mg bid
Arm Title
120 mg
Arm Type
Experimental
Arm Description
PPI+lesogaberan (AZD3355) 120 mg bid
Arm Title
180 mg
Arm Type
Experimental
Arm Description
PPI+lesogaberan (AZD3355) 180 mg bid
Arm Title
240 mg
Arm Type
Experimental
Arm Description
PPI+lesogaberan (AZD3355) 240 mg bid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
PPI+ Placebo
Intervention Type
Drug
Intervention Name(s)
lesogaberan (AZD3355)
Intervention Description
60 mg, oral, capsules, bid for 4 w
Intervention Type
Drug
Intervention Name(s)
lesogaberan (AZD3355)
Intervention Description
120 mg, oral, capsules, bid for 4 w
Intervention Type
Drug
Intervention Name(s)
lesogaberan (AZD3355)
Intervention Description
180 mg, oral, capsules, bid for 4 w
Intervention Type
Drug
Intervention Name(s)
lesogaberan (AZD3355)
Intervention Description
240 mg, oral, capsules, bid for 4 w
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral,capsules, bid for 4 w
Primary Outcome Measure Information:
Title
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)
Description
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)
Time Frame
The 7 days before randomisation (baseline) and during 26-30 days of treatment
Secondary Outcome Measure Information:
Title
Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.
Description
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)
Time Frame
The 7 days before randomisation (baseline) and during 26-30 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Silberg, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nicholas Shaheen, MD, MPH
Organizational Affiliation
UNC Hospitals, 4141Chapel Hill, NC 27599 USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23318482
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.
Results Reference
derived
PubMed Identifier
22730470
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.
Results Reference
derived

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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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