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Efficacy of Esomeprazole in Patients With Frequent Heartburn (NEXT2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01370538
First Posted: June 10, 2011
Last Update Posted: April 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn

Condition Intervention Phase
Heartburn Drug: Esomeprazole Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment [ Time Frame: From randomisation to day 14 ]

Secondary Outcome Measures:
  • Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period [ Time Frame: From randomisation to the day 14 ]
    Treatment period is considered to be both weeks 1 and 2 between V3 and V4.

  • Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo [ Time Frame: From randomisation to day 14 ]
    The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.

  • Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment [ Time Frame: From randomisation to day 14 ]
    There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.


Enrollment: 341
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Esomeprazole 20 mg Drug: Esomeprazole
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
Placebo Comparator: Placebo Drug: Esomeprazole
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and non-pregnant ,non-lactating females 18 years or older
  • Experience heartburn at least 2 days a week
  • Having heartburn that has responded to heartburn medication
  • Must discontinue any current heartburn medications

Exclusion Criteria:

  • Having a history of erosive esophagitis verified by endoscopy
  • Having a history of GERD which was diagnosed by a physician
  • Inability to take study medication or complete the study and all study procedures
  • Subjects that have required more than one 14-day course of PPI treatment within the past 4 months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370538


Locations
United States, Alabama
Research site
Mobile, Alabama, United States
United States, California
Research site
San Francisco, California, United States
Research site
Westlake Village, California, United States
United States, Kentucky
Research site
Lexington, Kentucky, United States
United States, New York
Research site
Rochester, New York, United States
United States, South Dakota
Research site
Dakota Dunes, South Dakota, United States
United States, Tennessee
Research site
Nashville, Tennessee, United States
United States, Texas
Research site
Austin, Texas, United States
Research site
San Angelo, Texas, United States
United States, Utah
Research site
West Jordan, Utah, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Tore Lind, MD AstraZeneca
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01370538     History of Changes
Other Study ID Numbers: D961RC00002
First Submitted: June 1, 2011
First Posted: June 10, 2011
Results First Submitted: October 19, 2012
Results First Posted: April 11, 2013
Last Update Posted: April 11, 2013
Last Verified: March 2013

Keywords provided by AstraZeneca:
Heartburn

Additional relevant MeSH terms:
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action