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Completed

NCT Number: NCT01037452

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

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.

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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 2

Primary location

Anaheim, California, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Experiencing heartburn in the past month if untreated
  • Having heartburn that responds to heartburn medication
  • Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.

Exclusion criteria

  • Having history of erosive esophagitis or gastroesophageal reflux disease (GERD) diagnosed by a physician and confirmed by testing (endoscopy)
  • Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.

"Other protocol-defined inclusion/exclusion criteria may apply"

Treatment and study plan

Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg

Drug

Tablet

Lansoprazole

Drug

Tablet

Calcium carbonate/magnesium hydroxide

Drug

Tablet

Placebo

Drug

Tablet

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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 15 mg and Antacid Versus Lansoprazole 15 mg and Antacid (Calcium Carbonate and Magnesium Hydroxide) Alone

Important dates

Study start
2009
Primary completion
2010
First posted
Dec 23, 2009
Registry last updated
Mar 28, 2011

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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