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

Heartburn Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037452
• Other study ID #: 145-G-201
• Status: Completed
• Phase: Phase 2
• First received: December 22, 2009
• Last updated: March 1, 2011
• Start date: December 2009

Study information

• Verified date: March 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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"

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heartburn

Intervention

Drug:
• Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg
Tablet
• Lansoprazole
Tablet
• Calcium carbonate/magnesium hydroxide
Tablet
• Placebo
Tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal	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.	1 day	No
Secondary	Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals	Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.; 0 millimeters: None (no heartburn) 100 millimeters: Most severe	1 day	No
Secondary	Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn	Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.; 0 millimeters: None (no heartburn) 100 millimeters: Most severe	1 day	No
Secondary	Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.		1 day	No