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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

October 27, 2009
October 30, 2009
February 23, 2011
April 25, 2011
April 25, 2011
October 2009
July 2010   (Final data collection date for primary outcome 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) [ 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)

Twice daily e-diary recordings of GERD symptoms (using e-diary device) [ Time Frame: Visit 1-6 (5-6 weeks) ]
Complete list of historical versions of study NCT01005251 on ClinicalTrials.gov Archive Site
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)

Pharmacokinetic measurements of 'Plasma concentration versus time' and 'Total plasma clearance' [ Time Frame: Visit 1-6 ]
Not Provided
Not Provided
 
Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI
Not Provided
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Gastroesophageal Reflux Disease
  • Heartburn
  • Regurgitation
  • Drug: lesogaberan (AZD3355)
    60 mg, oral, capsules, bid for 4 w
  • Drug: lesogaberan (AZD3355)
    120 mg, oral, capsules, bid for 4 w
  • Drug: lesogaberan (AZD3355)
    180 mg, oral, capsules, bid for 4 w
  • Drug: lesogaberan (AZD3355)
    240 mg, oral, capsules, bid for 4 w
  • Drug: Placebo
    oral,capsules, bid for 4 w
  • Experimental: 60 mg
    PPI+lesogaberan (AZD3355) 60 mg bid
    Intervention: Drug: lesogaberan (AZD3355)
  • Experimental: 120 mg
    PPI+lesogaberan (AZD3355) 120 mg bid
    Intervention: Drug: lesogaberan (AZD3355)
  • Experimental: 180 mg
    PPI+lesogaberan (AZD3355) 180 mg bid
    Intervention: Drug: lesogaberan (AZD3355)
  • Experimental: 240 mg
    PPI+lesogaberan (AZD3355) 240 mg bid
    Intervention: Drug: lesogaberan (AZD3355)
  • Placebo Comparator: Placebo
    PPI+ Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
661
650
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01005251
D9120C00019
Not Provided
Not Provided
Not Provided
MSD, AstraZeneca
AstraZeneca
Not Provided
Study Director: Debra Silberg, MD AstraZeneca
Principal Investigator: Nicholas Shaheen, MD, MPH UNC Hospitals, 4141Chapel Hill, NC 27599 USA
AstraZeneca
March 2011

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