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Efficacy of Esomeprazole in Patients With Frequent Heartburn (NEXT2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01370538
First received: June 1, 2011
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Heartburn
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01370538     History of Changes
Other Study ID Numbers: D961RC00002
Study First Received: June 1, 2011
Results First Received: October 19, 2012
Last Updated: March 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Heartburn

Additional relevant MeSH terms:
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Omeprazole
Anti-Ulcer Agents
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013