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Efficacy of Esomeprazole in Patients With Frequent Heartburn (NEXT1)

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: June 1, 2011
Last updated: February 12, 2013
Last verified: February 2013
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 ]
  • Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment [ Time Frame: From randomization 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 day 14 ]
    Randomized treatment period is considered as 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 the 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: 340
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


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01370525

United States, California
Research site
Sacramento, California, United States
United States, Florida
Research site
Seminole, Florida, United States
United States, Idaho
Research site
Meridian, Idaho, United States
United States, Indiana
Research site
Indianapolis, Indiana, United States
United States, Louisiana
Research site
Metairie, Louisiana, United States
United States, Nebraska
Research site
Omaha, Nebraska, United States
United States, North Carolina
Research site
Raleigh, North Carolina, United States
United States, Ohio
Research site
Cleveland, Ohio, United States
United States, South Carolina
Research site
Mt Pleasant, South Carolina, United States
United States, Texas
Research site
San Antonio, Texas, United States
Sponsors and Collaborators
Study Director: Tore Lind, MD AstraZeneca
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT01370525     History of Changes
Other Study ID Numbers: D961RC00001
Study First Received: June 1, 2011
Results First Received: October 19, 2012
Last Updated: February 12, 2013

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017