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Completed

NCT Number: NCT01370525

Efficacy of Esomeprazole in Patients With Frequent Heartburn

This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn

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Key information

Conditions

Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research site, Sacramento, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole

Drug

Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose

Primary outcomes

  1. Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment

    Time frame: From randomisation to day 14

  2. Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment

    Time frame: From randomization to day 14

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: NEXT1

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 10, 2011
Registry last updated
Mar 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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