Trial Outcomes & Findings for Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD) (NCT NCT00992589)

NCT ID: NCT00992589

Last Updated: 2013-05-22

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

344 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2013-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	Open-Label Rabeprazole Sodium 10 mg Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Placebo Matching placebo capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg Rabeprazole Sodium capsules once daily in the morning.
Open-Label Phase STARTED	344	0	0	0
Open-Label Phase COMPLETED	267	0	0	0
Open-Label Phase NOT COMPLETED	77	0	0	0
Double-Blind Phase STARTED	0	89	90	88
Double-Blind Phase COMPLETED	0	76	77	78
Double-Blind Phase NOT COMPLETED	0	13	13	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Open-Label Rabeprazole Sodium 10 mg Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Placebo Matching placebo capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg Rabeprazole Sodium capsules once daily in the morning.
Open-Label Phase Adverse Event	4	0	0	0
Open-Label Phase Withdrawal by Subject	20	0	0	0
Open-Label Phase Lost to Follow-up	1	0	0	0
Open-Label Phase Protocol Violation	3	0	0	0
Open-Label Phase Physician Decision	4	0	0	0
Open-Label Phase Other	45	0	0	0
Double-Blind Phase Adverse Event	0	6	2	3
Double-Blind Phase Withdrawal by Subject	0	6	5	2
Double-Blind Phase Lost to Follow-up	0	0	0	2
Double-Blind Phase Other	0	1	6	3

Baseline Characteristics

Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-Label Rabeprazole Sodium 10 mg n=344 Participants Rabeprazole Sodium capsules once daily in the morning.
Age Continuous	4.6 months STANDARD_DEVIATION 2.55 • n=99 Participants
Sex: Female, Male Female	139 Participants n=99 Participants
Sex: Female, Male Male	205 Participants n=99 Participants
Region of Enrollment AUSTRALIA	7 participants n=99 Participants
Region of Enrollment BELGIUM	11 participants n=99 Participants
Region of Enrollment BULGARIA	24 participants n=99 Participants
Region of Enrollment HUNGARY	51 participants n=99 Participants
Region of Enrollment ISRAEL	36 participants n=99 Participants
Region of Enrollment ITALY	5 participants n=99 Participants
Region of Enrollment NETHERLANDS	9 participants n=99 Participants
Region of Enrollment POLAND	56 participants n=99 Participants
Region of Enrollment SOUTH AFRICA	12 participants n=99 Participants
Region of Enrollment UNITED STATES	133 participants n=99 Participants
AgeCategorical >= 1 to < 4 Months	175 participants n=99 Participants
AgeCategorical >= 4 to < 8 Months	124 participants n=99 Participants
AgeCategorical >= 8 to < 12 Months	45 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.

Outcome measures

Outcome measures
Measure	Double-Blind Placebo n=88 Participants Matching placebo capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg n=88 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg n=85 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total n=173 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg - Week 8 Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg - Week 8 Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Baseline Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Week 8 Rabeprazole Sodium capsules once daily in the morning.
Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)	-0.8 frequency of Regurgitation Standard Deviation 1.58	-0.8 frequency of Regurgitation Standard Deviation 1.55	-1.6 frequency of Regurgitation Standard Deviation 3.63	-1.2 frequency of Regurgitation Standard Deviation 2.79	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Week 8

Body weight was measured with the participant unclothed and before a feeding during each office visit. In the analysis of weight data, weight will be transformed to the weight-for-age Z-score using World Health Organization Child Growth Standards, taking into account the infant's age and gender (Borghi E, 2006).

Outcome measures

Outcome measures
Measure	Double-Blind Placebo n=89 Participants Matching placebo capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg n=90 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg n=88 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total n=178 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg - Week 8 Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg - Week 8 Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Baseline Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Week 8 Rabeprazole Sodium capsules once daily in the morning.
Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward)	0.11 Z-score Standard Deviation 0.329	0.16 Z-score Standard Deviation 0.322	0.11 Z-score Standard Deviation 0.264	0.14 Z-score Standard Deviation 0.295	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Week 8

The Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R) is a 12-item questionnaire that is completed by the primary caregiver at every office or telephonic visit. It has a weekly recall and the items cover the frequency, amount and discomfort attributed to spit-up, refusal or stopping feeding, crying and fussing, hiccups, arching back and stopping breathing or changing color. The total score is calculated as the sum of all 12 scores for the individual questions, and ranges from 0 to 42. A higher value indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Double-Blind Placebo n=89 Participants Matching placebo capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg n=89 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg n=87 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total n=176 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg - Week 8 Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg - Week 8 Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Baseline Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Week 8 Rabeprazole Sodium capsules once daily in the morning.
Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward)	-3.6 scores on a scale Standard Deviation 6.41	-3.8 scores on a scale Standard Deviation 7.5	-4.1 scores on a scale Standard Deviation 7	-3.9 scores on a scale Standard Deviation 7.24	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Week 8

The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the participant has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. Each of the 9 items will be assigned a numeric score. The total score will be calculated as the sum of all 9 items, and ranges from 0 to 37. A higher value indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Double-Blind Placebo n=88 Participants Matching placebo capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg n=88 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg n=85 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total n=173 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg - Week 8 Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg - Week 8 Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Baseline Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Week 8 Rabeprazole Sodium capsules once daily in the morning.
Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward)	-1.9 scores on a scale Standard Deviation 4.55	-1.6 scores on a scale Standard Deviation 4.85	-2.1 scores on a scale Standard Deviation 4.9	-1.9 scores on a scale Standard Deviation 4.86	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Outcome measures

Outcome measures
Measure	Double-Blind Placebo n=89 Participants Matching placebo capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg n=90 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg n=88 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total n=89 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg - Week 8 n=90 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg - Week 8 n=88 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Baseline n=178 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Week 8 n=178 Participants Rabeprazole Sodium capsules once daily in the morning.
The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period More than 2 fluid oz to 4 fluid oz	0.1 number of episodes Standard Deviation 0.19	0.0 number of episodes Standard Deviation 0.09	0.0 number of episodes Standard Deviation 0.08	0.0 number of episodes Standard Deviation 0.09	0.0 number of episodes Standard Deviation 0.14	0.0 number of episodes Standard Deviation 0.23	0.0 number of episodes Standard Deviation 0.08	0.0 number of episodes Standard Deviation 0.19
The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period Less than 1 tablespoon	1.2 number of episodes Standard Deviation 2.52	1.1 number of episodes Standard Deviation 1.49	1.9 number of episodes Standard Deviation 4.25	0.8 number of episodes Standard Deviation 2.15	0.7 number of episodes Standard Deviation 1.35	1.0 number of episodes Standard Deviation 1.92	1.5 number of episodes Standard Deviation 3.18	0.9 number of episodes Standard Deviation 1.66
The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period 1 to 2 tablespoons	0.7 number of episodes Standard Deviation 1.04	0.7 number of episodes Standard Deviation 1.08	1.2 number of episodes Standard Deviation 1.73	0.5 number of episodes Standard Deviation 1.62	0.4 number of episodes Standard Deviation 0.75	0.7 number of episodes Standard Deviation 1.55	1.0 number of episodes Standard Deviation 1.45	0.6 number of episodes Standard Deviation 1.21
The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period More than 2 tablespoons to 2 fluid oz	0.3 number of episodes Standard Deviation 0.53	0.2 number of episodes Standard Deviation 0.43	0.3 number of episodes Standard Deviation 0.77	0.2 number of episodes Standard Deviation 0.48	0.1 number of episodes Standard Deviation 0.60	0.2 number of episodes Standard Deviation 0.65	0.2 number of episodes Standard Deviation 0.62	0.2 number of episodes Standard Deviation 0.63
The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period More than 4 fluid oz	0.0 number of episodes Standard Deviation 0.05	0.0 number of episodes Standard Deviation 0.14	0.0 number of episodes Standard Deviation 0.24	0.0 number of episodes Standard Deviation 0.11	0.0 number of episodes Standard Deviation 0.05	0.0 number of episodes Standard Deviation 0.04	0.0 number of episodes Standard Deviation 0.20	0.0 number of episodes Standard Deviation 0.04

SECONDARY outcome

Timeframe: Baseline, Week 8

The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the participant has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Regurgitation subscale will be calculated as the sum of the 3 questions regarding regurgitation (Questions 1, 2, 3) and will range from 0 to 13. For each subscale score, a higher value indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Double-Blind Placebo n=88 Participants Matching placebo capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg n=88 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg n=85 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total n=173 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg - Week 8 Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg - Week 8 Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Baseline Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Week 8 Rabeprazole Sodium capsules once daily in the morning.
Change From Baseline in Weekly Average I-GERQ-DD Regurgitation Subscale Score (Double-blind Phase/ Last Observation Carried Forward)	-0.8 scores on a scale Standard Deviation 2.57	-0.8 scores on a scale Standard Deviation 2.56	-1.0 scores on a scale Standard Deviation 2.38	-0.9 scores on a scale Standard Deviation 2.47	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 8

The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the subject has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Discomfort subscale score will be calculated as the sum of the 3 questions regarding discomfort (Questions, 7, 8, 9) and will range from 0 to 12. For each subscale score, a higher value indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Double-Blind Placebo n=88 Participants Matching placebo capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg n=88 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg n=85 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total n=173 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg - Week 8 Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg - Week 8 Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Baseline Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Week 8 Rabeprazole Sodium capsules once daily in the morning.
Change From Baseline in Weekly Average I-GERQ-DD Discomfort Subscale Score (Double-blind Phase/ Last Observation Carried Forward)	0.0 scores on a scale Standard Deviation 2.24	-0.1 scores on a scale Standard Deviation 1.88	-0.4 scores on a scale Standard Deviation 1.94	-0.2 scores on a scale Standard Deviation 1.9	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 8

The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the subject has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Eating Behavior subscale score will be calculated as the sum of the 3 questions regarding eating behavior (Questions 4, 5, 6) and will range from 0 to 12. For each subscale score, a higher value indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Double-Blind Placebo n=88 Participants Matching placebo capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg n=88 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg n=85 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total n=173 Participants Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg - Week 8 Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg - Week 8 Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Baseline Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium Total - Week 8 Rabeprazole Sodium capsules once daily in the morning.
Change From Baseline in Weekly Average I-GERQ-DD Eating Behavior Subscale Score (Double-blind Phase/ Last Observation Carried Forward)	-0.1 scores on a scale Standard Deviation 2.54	-0.1 scores on a scale Standard Deviation 2.19	-0.4 scores on a scale Standard Deviation 2.15	-0.3 scores on a scale Standard Deviation 2.17	—	—	—	—

Adverse Events

Open-Label Rabeprazole Sodium 10 mg

Serious events: 15 serious events

Other events: 116 other events

Deaths: 0 deaths

Double-Blind Placebo

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

Double-Blind Rabeprazole Sodium 5 mg

Serious events: 8 serious events

Other events: 34 other events

Deaths: 0 deaths

Double-Blind Rabeprazole Sodium 10 mg

Serious events: 3 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Open-Label Rabeprazole Sodium 10 mg n=344 participants at risk Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Placebo n=89 participants at risk Matching placebo capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg n=90 participants at risk Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg n=88 participants at risk Rabeprazole Sodium capsules once daily in the morning.
Ear and labyrinth disorders Hypoacusis	0.29% 1/344	1.1% 1/89	0.00% 0/90	0.00% 0/88
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.29% 1/344	0.00% 0/89	0.00% 0/90	0.00% 0/88
General disorders Pyrexia	0.29% 1/344	0.00% 0/89	1.1% 1/90	0.00% 0/88
Infections and infestations Bronchiolitis	0.29% 1/344	0.00% 0/89	0.00% 0/90	1.1% 1/88
Infections and infestations Gastroenteritis	0.58% 2/344	0.00% 0/89	2.2% 2/90	0.00% 0/88
Infections and infestations Upper Respiratory Tract Infection	0.58% 2/344	0.00% 0/89	2.2% 2/90	0.00% 0/88
Infections and infestations Urinary Tract Infection	0.58% 2/344	0.00% 0/89	2.2% 2/90	0.00% 0/88
Infections and infestations Viral Infection	0.29% 1/344	0.00% 0/89	0.00% 0/90	1.1% 1/88
Investigations Beta 2 Microglobulin Increased	0.29% 1/344	0.00% 0/89	0.00% 0/90	1.1% 1/88
Metabolism and nutrition disorders Dehydration	0.29% 1/344	0.00% 0/89	0.00% 0/90	0.00% 0/88
Metabolism and nutrition disorders Failure to Thrive	0.58% 2/344	1.1% 1/89	0.00% 0/90	0.00% 0/88
Metabolism and nutrition disorders Metabolic Acidosis	0.29% 1/344	0.00% 0/89	0.00% 0/90	0.00% 0/88
Psychiatric disorders Agitation	0.29% 1/344	0.00% 0/89	1.1% 1/90	0.00% 0/88
Respiratory, thoracic and mediastinal disorders Stridor	0.29% 1/344	0.00% 0/89	1.1% 1/90	0.00% 0/88

Other adverse events

Other adverse events
Measure	Open-Label Rabeprazole Sodium 10 mg n=344 participants at risk Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Placebo n=89 participants at risk Matching placebo capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 5 mg n=90 participants at risk Rabeprazole Sodium capsules once daily in the morning.	Double-Blind Rabeprazole Sodium 10 mg n=88 participants at risk Rabeprazole Sodium capsules once daily in the morning.
Gastrointestinal disorders Constipation	4.4% 15/344	4.5% 4/89	2.2% 2/90	5.7% 5/88
Gastrointestinal disorders Diarrhoea	6.1% 21/344	7.9% 7/89	8.9% 8/90	4.5% 4/88
Gastrointestinal disorders Gastrooesophageal Reflux Disease	3.8% 13/344	7.9% 7/89	2.2% 2/90	4.5% 4/88
Gastrointestinal disorders Vomiting	3.8% 13/344	5.6% 5/89	6.7% 6/90	2.3% 2/88
General disorders Pyrexia	6.4% 22/344	5.6% 5/89	10.0% 9/90	6.8% 6/88
Infections and infestations Nasopharyngitis	5.5% 19/344	4.5% 4/89	8.9% 8/90	3.4% 3/88
Infections and infestations Otitis Media	4.1% 14/344	4.5% 4/89	5.6% 5/90	3.4% 3/88
Infections and infestations Upper Respiratory Tract Infection	5.5% 19/344	6.7% 6/89	3.3% 3/90	9.1% 8/88
Investigations Blood Gastrin Increased	2.9% 10/344	0.00% 0/89	2.2% 2/90	8.0% 7/88
Skin and subcutaneous tissue disorders Rash	3.5% 12/344	4.5% 4/89	5.6% 5/90	2.3% 2/88

Additional Information

PORTFOLIO/CDT LEADER

Janssen R&D US

Phone: 1 609 730-2548

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60