Trial Outcomes & Findings for Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn (NCT NCT01037452)
NCT ID: NCT01037452
Last Updated: 2011-03-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
1 day
Results posted on
2011-03-28
Participant Flow
Participant milestones
| Measure |
Combination Product
Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
|
PPI Alone
Lansoprazole 15 mg, single dose
|
Antacid Alone
Calcium carbonate/magnesium hydroxide, single dose
|
Placebo
Placebo, single dose
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn
Baseline characteristics by cohort
| Measure |
Combination Product
n=30 Participants
Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
|
PPI Alone
n=30 Participants
Lansoprazole 15 mg, single dose
|
Antacid Alone
n=30 Participants
Calcium carbonate/magnesium hydroxide, single dose
|
Placebo
n=30 Participants
Placebo, single dose
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
119 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Age Continuous
|
33.7 years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
30.4 years
STANDARD_DEVIATION 11.1 • n=107 Participants
|
30.9 years
STANDARD_DEVIATION 13.3 • n=206 Participants
|
31.9 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
31.7 years
STANDARD_DEVIATION 12.1 • n=31 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
57 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
63 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
30 participants
n=206 Participants
|
30 participants
n=7 Participants
|
120 participants
n=31 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 1 dayParticipant 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.
Outcome measures
| Measure |
Combination Product
n=30 Participants
Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
|
PPI Alone
n=30 Participants
Lansoprazole 15 mg, single dose
|
Antacid Alone
n=30 Participants
Calcium carbonate/magnesium hydroxide, single dose
|
Placebo
n=30 Participants
Placebo, single dose
|
|---|---|---|---|---|
|
Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal
|
0 participants
Interval 0.0 to 11.6
|
2 participants
Interval 0.8 to 22.1
|
1 participants
Interval 0.1 to 17.2
|
0 participants
Interval 0.0 to 11.6
|
SECONDARY outcome
Timeframe: 1 dayHeartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long. 0 millimeters: None (no heartburn) 100 millimeters: Most severe
Outcome measures
| Measure |
Combination Product
n=30 Participants
Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
|
PPI Alone
n=30 Participants
Lansoprazole 15 mg, single dose
|
Antacid Alone
n=30 Participants
Calcium carbonate/magnesium hydroxide, single dose
|
Placebo
n=30 Participants
Placebo, single dose
|
|---|---|---|---|---|
|
Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals
|
69.3 millimeters
Interval 62.8 to 75.8
|
61.2 millimeters
Interval 51.6 to 70.7
|
59.1 millimeters
Interval 50.5 to 67.8
|
56.9 millimeters
Interval 50.4 to 63.4
|
SECONDARY outcome
Timeframe: 1 dayHeartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long. 0 millimeters: None (no heartburn) 100 millimeters: Most severe
Outcome measures
| Measure |
Combination Product
n=30 Participants
Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
|
PPI Alone
n=30 Participants
Lansoprazole 15 mg, single dose
|
Antacid Alone
n=30 Participants
Calcium carbonate/magnesium hydroxide, single dose
|
Placebo
n=30 Participants
Placebo, single dose
|
|---|---|---|---|---|
|
Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn
|
8.2 millimeters
Interval 0.4 to 16.0
|
7.0 millimeters
Interval -1.0 to 15.0
|
4.7 millimeters
Interval -0.9 to 10.2
|
4.0 millimeters
Interval -1.6 to 9.6
|
SECONDARY outcome
Timeframe: 1 dayOutcome measures
| Measure |
Combination Product
n=30 Participants
Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
|
PPI Alone
n=30 Participants
Lansoprazole 15 mg, single dose
|
Antacid Alone
n=30 Participants
Calcium carbonate/magnesium hydroxide, single dose
|
Placebo
n=30 Participants
Placebo, single dose
|
|---|---|---|---|---|
|
Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
Adverse Events
Combination Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PPI Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Antacid Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Head New Therapeutic Opportunities
Novartis
Phone: 973-503-8000
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60