NCT01005251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
661

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
10 months until next milestone

Results Posted

Study results publicly available

April 25, 2011

Completed
Last Updated

April 25, 2011

Status Verified

March 1, 2011

Enrollment Period

9 months

First QC Date

October 27, 2009

Results QC Date

February 23, 2011

Last Update Submit

March 29, 2011

Conditions

Gastroesophageal Reflux DiseaseHeartburnRegurgitation

Keywords

GERD treatmentAcid and non-acid RefluxHeartburnRegurgitationAdd-on treatment to PPI

Outcome Measures

Primary Outcomes (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)

    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)

    The 7 days before randomisation (baseline) and during 26-30 days of treatment

Secondary Outcomes (1)

  • Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.

    The 7 days before randomisation (baseline) and during 26-30 days of treatment

Study Arms (5)

60 mg

EXPERIMENTAL

PPI+lesogaberan (AZD3355) 60 mg bid

Drug: lesogaberan (AZD3355)

120 mg

EXPERIMENTAL

PPI+lesogaberan (AZD3355) 120 mg bid

Drug: lesogaberan (AZD3355)

180 mg

EXPERIMENTAL

PPI+lesogaberan (AZD3355) 180 mg bid

Drug: lesogaberan (AZD3355)

240 mg

EXPERIMENTAL

PPI+lesogaberan (AZD3355) 240 mg bid

Drug: lesogaberan (AZD3355)

Placebo

PLACEBO COMPARATOR

PPI+ Placebo

Drug: Placebo

Interventions

lesogaberan (AZD3355)DRUG

60 mg, oral, capsules, bid for 4 w

60 mg
PlaceboDRUG

oral,capsules, bid for 4 w

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Oklahoma City, Oklahoma, United States

Location

Related Publications (2)

  • 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.

    PMID: 23318482DERIVED

  • 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.

    PMID: 22730470DERIVED

MeSH Terms

Conditions

Gastroesophageal RefluxHeartburn

Interventions

lesogaberan

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Debra Silberg, MD

    AstraZeneca

    STUDY DIRECTOR

  • Nicholas Shaheen, MD, MPH

    UNC Hospitals, 4141Chapel Hill, NC 27599 USA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 30, 2009

Study Start

October 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

April 25, 2011

Results First Posted

April 25, 2011

Record last verified: 2011-03

Locations

US(1)