Trial Outcomes & Findings for Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD) (NCT NCT00373334)
NCT ID: NCT00373334
Last Updated: 2009-11-18
Results Overview
The I-GERQ-R contains 12 questions assessing gastroesophageal reflux disease (GERD) frequency and severity. A low I-GERQ-R score (minimum = 0) indicates minimal symptoms and a high I-GERQ-R score (maximum = 42) indicates more frequent and/or severe symptoms. Success is defined as a reduction in I-GERQ-R score of at least 5 points from baseline, provided a subject did not discontinue due to lack of efficacy or adverse event, and had been treated for at least 4 weeks.
COMPLETED
PHASE3
138 participants
8 weeks
2009-11-18
Participant Flow
Participant milestones
| Measure |
Nizatidine 2.5 mg/kg Twice Daily
low dose nizatidine plus Conservative Measures
|
Nizatidine 5.0 mg/kg Twice Daily
high dose nizatidine plus Conservative Measures
|
Placebo
Placebo plus Conservative Measures
Conservative Measures included:
Hypoallergenic formula thickened with dry rice cereal Avoidance of seated and supine positioning Elimination of tobacco smoke exposure
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
50
|
45
|
|
Overall Study
COMPLETED
|
33
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
10
|
18
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)
Baseline characteristics by cohort
| Measure |
Nizatidine 2.5 mg/kg b.i.d.
n=43 Participants
|
Nizatidine 5.0 mg/kg b.i.d.
n=50 Participants
|
Conservative Measures Only
n=45 Participants
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
43 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
50 participants
n=7 Participants
|
45 participants
n=5 Participants
|
138 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The analysis population includes all patients that took drug and had any efficacy data reported. 5 patients that were lost to follow up (1 nizatidine 2.5 group, 1 nizatidine 5.0 group, 3 placebo group) were not included because they had no efficacy data and had not reported any adverse events.
The I-GERQ-R contains 12 questions assessing gastroesophageal reflux disease (GERD) frequency and severity. A low I-GERQ-R score (minimum = 0) indicates minimal symptoms and a high I-GERQ-R score (maximum = 42) indicates more frequent and/or severe symptoms. Success is defined as a reduction in I-GERQ-R score of at least 5 points from baseline, provided a subject did not discontinue due to lack of efficacy or adverse event, and had been treated for at least 4 weeks.
Outcome measures
| Measure |
Nizatidine 2.5 mg/kg b.i.d.
n=42 Participants
|
Nizatidine 5.0 mg/kg b.i.d.
n=49 Participants
|
Conservative Measures Only
n=42 Participants
|
|---|---|---|---|
|
Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success
|
27 participants
|
32 participants
|
31 participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The analysis population includes all patients that took drug and reached the 8 week study timepoint.
Subjective investigator assessment of GERD relief - rating categories were BETTER, NO CHANGE, or WORSE from baseline.
Outcome measures
| Measure |
Nizatidine 2.5 mg/kg b.i.d.
n=41 Participants
|
Nizatidine 5.0 mg/kg b.i.d.
n=44 Participants
|
Conservative Measures Only
n=39 Participants
|
|---|---|---|---|
|
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief
Better
|
32 participants
|
36 participants
|
29 participants
|
|
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief
No Change
|
4 participants
|
2 participants
|
6 participants
|
|
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief
Worse
|
5 participants
|
6 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The analysis population includes all patients that took drug and reached the 8 week study timepoint.
Subjective investigator assessment of GERD severity - rating categories were NONE, MILD, MODERATE, or SEVERE.
Outcome measures
| Measure |
Nizatidine 2.5 mg/kg b.i.d.
n=41 Participants
|
Nizatidine 5.0 mg/kg b.i.d.
n=44 Participants
|
Conservative Measures Only
n=38 Participants
|
|---|---|---|---|
|
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity
None
|
3 participants
|
7 participants
|
5 participants
|
|
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity
Mild
|
25 participants
|
26 participants
|
25 participants
|
|
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity
Moderate
|
10 participants
|
9 participants
|
7 participants
|
|
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity
Severe
|
3 participants
|
2 participants
|
1 participants
|
Adverse Events
Nizatidine 2.5 mg/kg b.i.d.
Nizatidine 5.0 mg/kg b.i.d.
Conservative Measures Only
Serious adverse events
| Measure |
Nizatidine 2.5 mg/kg b.i.d.
n=43 participants at risk
|
Nizatidine 5.0 mg/kg b.i.d.
n=50 participants at risk
|
Conservative Measures Only
n=45 participants at risk
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/43
|
0.00%
0/50
|
2.2%
1/45 • Number of events 1
|
Other adverse events
| Measure |
Nizatidine 2.5 mg/kg b.i.d.
n=43 participants at risk
|
Nizatidine 5.0 mg/kg b.i.d.
n=50 participants at risk
|
Conservative Measures Only
n=45 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
9.3%
4/43
|
8.0%
4/50
|
11.1%
5/45
|
|
General disorders
Pyrexia
|
14.0%
6/43
|
2.0%
1/50
|
6.7%
3/45
|
|
Gastrointestinal disorders
Teething
|
9.3%
4/43
|
6.0%
3/50
|
6.7%
3/45
|
|
Infections and infestations
bronchiolitis
|
7.0%
3/43
|
12.0%
6/50
|
4.4%
2/45
|
|
Eye disorders
conjunctivitis
|
0.00%
0/43
|
6.0%
3/50
|
0.00%
0/45
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/43
|
6.0%
3/50
|
4.4%
2/45
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
4.7%
2/43
|
20.0%
10/50
|
8.9%
4/45
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
7.0%
3/43
|
2.0%
1/50
|
8.9%
4/45
|
|
Infections and infestations
otitis media
|
18.6%
8/43
|
26.0%
13/50
|
15.6%
7/45
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory tract infection
|
30.2%
13/43
|
12.0%
6/50
|
33.3%
15/45
|
|
Gastrointestinal disorders
vomiting
|
4.7%
2/43
|
6.0%
3/50
|
2.2%
1/45
|
Additional Information
Clinical Operations Manager
Braintree Laboratories, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the principal investigator is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 360 days from the time submitted to the sponsor for review. The sponsor cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER