Clinical Trial: Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Group Proof-of-Concept Trial to Assess Relief of Meal Induced Heartburn by a Combination of Lansoprazole

Brief Summary: This study will investigate the safety and efficacy of an antacid/Lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal.

Detailed Summary:
Sponsor: Novartis

Current Primary Outcome: Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal [ Time Frame: 1 day ]

Participant reported severity of heartburn using a Visual Analog Scale (VAS)directly on CRF every 15 minutes until no heartburn reported or up to 5 hours after 1st heartburn-inducing meal, whichever occurred first. At this point in time, a diary was provided to participants to record any changes in severity of heartburn for 28 hours post treatment.


Original Primary Outcome: Measure: Proportion of subjects with no heartburn (post treatment) following consumption of heartburn-inducing meal [ Time Frame: 1 day ]

Current Secondary Outcome:

  • Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals [ Time Frame: 1 day ]

    Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.

    0 millimeters: None (no heartburn) 100 millimeters: Most severe

  • Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn [ Time Frame: 1 day ]

    Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.

    0 millimeters: None (no heartburn) 100 millimeters: Most severe

  • Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo. [ Time Frame: 1 day ]


Original Secondary Outcome:

  • Measure: Maximum heartburn intensity for those subjects who experience any heartburn after the heartburn-inducing meals [ Time Frame: 1 day ]
  • Measure: Maximum heartburn intensity for those subjects who experience any nighttime heartburn [ Time Frame: 1 day ]
  • Measure: Safety of the combination product [ Time Frame: 1 day ]


Information By: Novartis

Dates:
Date Received: December 22, 2009
Date Started: December 2009
Date Completion:
Last Updated: March 1, 2011
Last Verified: March 2011