Efficacy of Esomeprazole in Patients With Frequent Heartburn (NEXT1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01370525
First received: June 1, 2011
Last updated: February 12, 2013
Last verified: February 2013

June 1, 2011
February 12, 2013
August 2011
October 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment [ Time Frame: From randomization to day 14 ] [ Designated as safety issue: No ]
Determine efficacy during free 24-hour days during 14 days of treatment [ Time Frame: During the 2 weeks of treatment ] [ Designated as safety issue: No ]
Determine efficacy of esomeprazole 20 mg daily for the treatment of frequent heartburn as determined by the percentage of heartburn free 24-hour days during 14 days of treatment.
Complete list of historical versions of study NCT01370525 on ClinicalTrials.gov Archive Site
  • Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period [ Time Frame: From randomisation to day 14 ] [ Designated as safety issue: No ]
    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 ] [ 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.
  • Determine proportion of subjects during the final week of treatment [ Time Frame: During last 7 days of the 2 week treatment ] [ Designated as safety issue: No ]
    Determine the proportion of subjects with resolution of frequent heartburn as defined by a subject reporting 1 day of heartburn or less during the final week of treatment.
  • Determine efficacy over days 1-4 [ Time Frame: During first 4 days of the 2 week treatment ] [ Designated as safety issue: No ]
    Determine efficacy of esomeprazole 20 mg daily for the treatment of frequent heartburn by the proportion of days with no heartburn over days 1-4.
Not Provided
Not Provided
 
Efficacy of Esomeprazole in Patients With Frequent Heartburn
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Heartburn
Drug: Esomeprazole
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
  • Experimental: Esomeprazole 20 mg
    Intervention: Drug: Esomeprazole
  • Placebo Comparator: Placebo
    Intervention: Drug: Esomeprazole
Peura DA, Traxler B, Kocun C, Lind T. Esomeprazole treatment of frequent heartburn: two randomized, double-blind, placebo-controlled trials. Postgrad Med. 2014 Jul;126(4):33-41. doi: 10.3810/pgm.2014.07.2781.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01370525
D961RC00001
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Tore Lind, MD AstraZeneca
AstraZeneca
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP