Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01037452
First received: December 22, 2009
Last updated: March 1, 2011
Last verified: March 2011
History of Changes

December 22, 2009
March 1, 2011
December 2009
January 2010   (final data collection date for primary outcome measure)
Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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.
Measure: Proportion of subjects with no heartburn (post treatment) following consumption of heartburn-inducing meal [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01037452 on ClinicalTrials.gov Archive Site
  • Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Measure: Maximum heartburn intensity for those subjects who experience any heartburn after the heartburn-inducing meals [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Measure: Maximum heartburn intensity for those subjects who experience any nighttime heartburn [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Measure: Safety of the combination product [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Heartburn
  • Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg
    Tablet
  • Drug: Lansoprazole
    Tablet
  • Drug: Calcium carbonate/magnesium hydroxide
    Tablet
  • Drug: Placebo
    Tablet
  • Experimental: Combination product
    Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet
    Intervention: Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg
  • Active Comparator: PPI alone
    Lansoprazole
    Intervention: Drug: Lansoprazole
  • Active Comparator: Antacid alone
    Calcium carbonate/magnesium hydroxide
    Intervention: Drug: Calcium carbonate/magnesium hydroxide
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
Not Provided
January 2010   (final data collection date for primary outcome measure)

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"
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01037452
145-G-201
Not Provided
Head, New Therapeutic Opportunities, Novartis
Novartis
Not Provided
Study Director: Novartis . Novartis
Novartis
March 2011

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