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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01037452
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heartburn	Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg; Drug: Lansoprazole; Drug: Calcium carbonate/magnesium hydroxide; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combination product Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet	Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg; Tablet
Active Comparator: PPI alone Lansoprazole	Drug: Lansoprazole; Tablet
Active Comparator: Antacid alone Calcium carbonate/magnesium hydroxide	Drug: Calcium carbonate/magnesium hydroxide; Tablet
Placebo Comparator: Placebo Placebo	Drug: Placebo; Tablet

Outcome Measures

Primary Outcome Measures

1. Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal [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 Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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"

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Anaheim	California	United States

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis ., Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01037452
• Other Study ID Numbers: 145-G-201
• First Posted: Dec 23, 2009
• Last Update Posted: Mar 28, 2011
• Last Verified: Mar 1, 2011

• Keywords provided by , ,: Heartburn; antacid; PPI; Lansoprazole; calcium carbonate; magnesium hydroxide; Relief of heartburn following ingestion of a heartburn-inducing meal
• Additional relevant MeSH terms: Heartburn; Calcium, Dietary; Lansoprazole; Dexlansoprazole; Calcium Carbonate; Magnesium Hydroxide; Calcium

Study Results

Participant Flow

Arm/Group Title	Combination Product	PPI Alone	Antacid Alone	Placebo
Arm/Group Description	Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose	Lansoprazole 15 mg, single dose	Calcium carbonate/magnesium hydroxide, single dose	Placebo, single dose
Period Title: Overall Study
STARTED	30	30	30	30
COMPLETED	30	30	30	30
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Combination Product	PPI Alone	Antacid Alone	Placebo	Total
Arm/Group Description	Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose	Lansoprazole 15 mg, single dose	Calcium carbonate/magnesium hydroxide, single dose	Placebo, single dose	Total of all reporting groups
Overall Participants	30	30	30	30	120
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	30 100%	30 100%	30 100%	29 96.7%	119 99.2%
>=65 years	0 0%	0 0%	0 0%	1 3.3%	1 0.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.7 (11.5)	30.4 (11.1)	30.9 (13.3)	31.9 (12.6)	31.7 (12.1)
Sex: Female, Male (Count of Participants)
Female	15 50%	14 46.7%	11 36.7%	17 56.7%	57 47.5%
Male	15 50%	16 53.3%	19 63.3%	13 43.3%	63 52.5%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	30 100%	30 100%	120 100%

Outcome Measures

1. Primary Outcome

Title	Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combination Product	PPI Alone	Antacid Alone	Placebo
Arm/Group Description	Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose	Lansoprazole 15 mg, single dose	Calcium carbonate/magnesium hydroxide, single dose	Placebo, single dose
Measure Participants	30	30	30	30
Number (95% Confidence Interval) [participants]	0 0%	2 6.7%	1 3.3%	0 0%

2. Secondary Outcome

Title	Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals
Description	Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long. 0 millimeters: None (no heartburn) 100 millimeters: Most severe
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combination Product	PPI Alone	Antacid Alone	Placebo
Arm/Group Description	Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose	Lansoprazole 15 mg, single dose	Calcium carbonate/magnesium hydroxide, single dose	Placebo, single dose
Measure Participants	30	30	30	30
Mean (95% Confidence Interval) [millimeters]	69.3	61.2	59.1	56.9

3. Secondary Outcome

Title	Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn
Description	Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long. 0 millimeters: None (no heartburn) 100 millimeters: Most severe
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combination Product	PPI Alone	Antacid Alone	Placebo
Arm/Group Description	Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose	Lansoprazole 15 mg, single dose	Calcium carbonate/magnesium hydroxide, single dose	Placebo, single dose
Measure Participants	30	30	30	30
Mean (95% Confidence Interval) [millimeters]	8.2	7.0	4.7	4.0

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Combination Product	PPI Alone	Antacid Alone	Placebo
Arm/Group Description	Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose	Lansoprazole 15 mg, single dose	Calcium carbonate/magnesium hydroxide, single dose	Placebo, single dose
Measure Participants	30	30	30	30
Number [participants]	0 0%	1 3.3%	0 0%	0 0%

Adverse Events

Arm/Group Title	Combination Product		PPI Alone		Antacid Alone		Placebo
Arm/Group Description	Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose		Lansoprazole 15 mg, single dose		Calcium carbonate/magnesium hydroxide, single dose		Placebo, single dose
All Cause Mortality
	Combination Product		PPI Alone		Antacid Alone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Combination Product		PPI Alone		Antacid Alone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Combination Product		PPI Alone		Antacid Alone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.