Trial Outcomes & Findings for A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age (NCT NCT01100606)
NCT ID: NCT01100606
Last Updated: 2014-04-10
Results Overview
Acceptability questionnaire consists of 9 question (Q) to assess ease, time, overall satisfaction of study drug. Rated on 5-point scale for Q1-Q5 and Q7-Q9; Q6 was not rated and asked for name of previous PEP administered. Q1=overall ease of administration (1=not at all easy,2=somewhat,3=easy,4=very,5=extremely); Q2=time of administration (1=very short\[\<2 min\],2=short\[2-5 min\],3=moderate\[5-15 min\],4=long\[15-25 min\],5=very long\[\>25 min\]);Q3=overall infant acceptance(1=very easily,2=easily,3=same,4=with difficulty,5=with great difficulty);Q4=clear/complete instructions(1=not clear,2=somewhat,3=clear,4=very,5=extremely);Q5=overall satisfaction with dosing method (1=not satisfied,2=somewhat,3=satisfied,4=very,5=extremely);Q7=comparative ease of administration (1=much worse,2=worse,3=same,4=better,5=much better);Q8=comparative infant acceptance (1=much more difficult,2=more,3=same,4=easier,5=much easier);Q9=comparative overall satisfaction (1=much less,2=less,3=same,4=more,5=much more).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
Baseline up to end of study (Day 21)
Results posted on
2014-04-10
Participant Flow
All enrolled participants were administered Zenpep® 5,000 (pancrelipase) from open capsule mixed with a small amount of apple sauce in the screening period for 10 days.
Participant milestones
| Measure |
EUR-1008 (APT-1008) in Apple Juice First, Then in Apple Sauce
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in first treatment period followed by EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in second treatment period. Total dose was not to exceed 10,000 lipase units/kilogram body weight/day (lipase units/kg/day).
|
EUR-1008 (APT-1008) in Apple Sauce First, Then in Apple Juice
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in first treatment period followed by EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in second treatment period. Total dose was not to exceed 10,000 lipase units/kg/day.
|
|---|---|---|
|
First Treatment Period
STARTED
|
8
|
7
|
|
First Treatment Period
COMPLETED
|
8
|
7
|
|
First Treatment Period
NOT COMPLETED
|
0
|
0
|
|
Second Treatment Period
STARTED
|
8
|
7
|
|
Second Treatment Period
COMPLETED
|
8
|
7
|
|
Second Treatment Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=15 Participants
Includes all enrolled participants who received EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) mixed with a small amount of apple juice using a syringe nurser first and EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) mixed with a small amount of apple sauce using a spoon first.
|
|---|---|
|
Age, Continuous
|
5.7 months
STANDARD_DEVIATION 3.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Average Daily Number of Stools
|
2.73 average number of stools per day
STANDARD_DEVIATION 1.393 • n=5 Participants
|
|
Number of Stools Categorized as Per Consistency
Hard
|
0.11 average number of stools per day
STANDARD_DEVIATION 0.255 • n=5 Participants
|
|
Number of Stools Categorized as Per Consistency
Normal
|
1.18 average number of stools per day
STANDARD_DEVIATION 1.129 • n=5 Participants
|
|
Number of Stools Categorized as Per Consistency
Soft
|
0.91 average number of stools per day
STANDARD_DEVIATION 0.777 • n=5 Participants
|
|
Number of Stools Categorized as Per Consistency
Diarrhea
|
0.48 average number of stools per day
STANDARD_DEVIATION 0.801 • n=5 Participants
|
|
Number of Stools With Signs of Blood and Visible Oil or Grease
With blood
|
0 average number of stools per day
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Number of Stools With Signs of Blood and Visible Oil or Grease
With visible oil or grease
|
0.11 average number of stools per day
STANDARD_DEVIATION 0.147 • n=5 Participants
|
|
Number of Abdominal Symptoms: Bloating
Mild Bloating
|
0.12 average number of bloating per day
STANDARD_DEVIATION 0.281 • n=5 Participants
|
|
Number of Abdominal Symptoms: Bloating
Moderate Bloating
|
0.04 average number of bloating per day
STANDARD_DEVIATION 0.101 • n=5 Participants
|
|
Number of Abdominal Symptoms: Bloating
Severe Bloating
|
0 average number of bloating per day
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Number of Abdominal Symptoms: Flatulence
Mild Flatulence
|
1.00 average number of flatulence per day
STANDARD_DEVIATION 1.208 • n=5 Participants
|
|
Number of Abdominal Symptoms: Flatulence
Moderate Flatulence
|
0.51 average number of flatulence per day
STANDARD_DEVIATION 0.728 • n=5 Participants
|
|
Number of Abdominal Symptoms: Flatulence
Severe Flatulence
|
0.03 average number of flatulence per day
STANDARD_DEVIATION 0.099 • n=5 Participants
|
|
Number of Abdominal Pain Symptoms
Mild Abdominal Pain
|
0.23 average number of pain symptoms per day
STANDARD_DEVIATION 0.409 • n=5 Participants
|
|
Number of Abdominal Pain Symptoms
Moderate Abdominal Pain
|
0.09 average number of pain symptoms per day
STANDARD_DEVIATION 0.185 • n=5 Participants
|
|
Number of Abdominal Pain Symptoms
Severe Abdominal Pain
|
0.02 average number of pain symptoms per day
STANDARD_DEVIATION 0.066 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of study (Day 21)Population: Intention-to-treat (ITT) population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of exocrine pancreatic insufficiency (EPI). Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.
Acceptability questionnaire consists of 9 question (Q) to assess ease, time, overall satisfaction of study drug. Rated on 5-point scale for Q1-Q5 and Q7-Q9; Q6 was not rated and asked for name of previous PEP administered. Q1=overall ease of administration (1=not at all easy,2=somewhat,3=easy,4=very,5=extremely); Q2=time of administration (1=very short\[\<2 min\],2=short\[2-5 min\],3=moderate\[5-15 min\],4=long\[15-25 min\],5=very long\[\>25 min\]);Q3=overall infant acceptance(1=very easily,2=easily,3=same,4=with difficulty,5=with great difficulty);Q4=clear/complete instructions(1=not clear,2=somewhat,3=clear,4=very,5=extremely);Q5=overall satisfaction with dosing method (1=not satisfied,2=somewhat,3=satisfied,4=very,5=extremely);Q7=comparative ease of administration (1=much worse,2=worse,3=same,4=better,5=much better);Q8=comparative infant acceptance (1=much more difficult,2=more,3=same,4=easier,5=much easier);Q9=comparative overall satisfaction (1=much less,2=less,3=same,4=more,5=much more).
Outcome measures
| Measure |
EUR-1008 (APT-1008) in Apple Juice
n=12 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
EUR-1008 (APT-1008) in Apple Sauce
n=12 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
|---|---|---|
|
Treatment Difference for Acceptability of Treatment
Ease of Administration
|
1.5 units on a scale
Interval 1.0 to 3.0
|
3.5 units on a scale
Interval 2.0 to 5.0
|
|
Treatment Difference for Acceptability of Treatment
Time of Administration
|
2.5 units on a scale
Interval 1.0 to 4.0
|
1.0 units on a scale
Interval 1.0 to 3.0
|
|
Treatment Difference for Acceptability of Treatment
Overall Infant Acceptance
|
3.5 units on a scale
Interval 2.0 to 5.0
|
1.5 units on a scale
Interval 1.0 to 4.0
|
|
Treatment Difference for Acceptability of Treatment
Dispensing Instructions
|
3.0 units on a scale
Interval 1.0 to 5.0
|
4.5 units on a scale
Interval 3.0 to 5.0
|
|
Treatment Difference for Acceptability of Treatment
Overall Satisfaction
|
1.0 units on a scale
Interval 1.0 to 3.0
|
3.0 units on a scale
Interval 2.0 to 4.0
|
|
Treatment Difference for Acceptability of Treatment
Comparative Ease of Administration
|
2.0 units on a scale
Interval 1.0 to 5.0
|
3.0 units on a scale
Interval 2.0 to 5.0
|
|
Treatment Difference for Acceptability of Treatment
Comparative Infant Acceptance
|
2.0 units on a scale
Interval 1.0 to 5.0
|
3.0 units on a scale
Interval 3.0 to 5.0
|
|
Treatment Difference for Acceptability of Treatment
Comparative Overall Satisfaction
|
1.0 units on a scale
Interval 1.0 to 4.0
|
3.0 units on a scale
Interval 3.0 to 5.0
|
PRIMARY outcome
Timeframe: BaselinePopulation: Safety analysis population included all participants who received at least 1 dose of study medication.
Acceptability questionnaire consists of 9 questions (Q) to assess the ease, time, overall satisfaction of study drug. Q6 included "name of previous PEP administered". Q6 was reported as number of participants who used any PEP prior to screening.
Outcome measures
| Measure |
EUR-1008 (APT-1008) in Apple Juice
n=15 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
EUR-1008 (APT-1008) in Apple Sauce
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
|---|---|---|
|
Question 6 (Previous Pancreatic Enzyme Product [PEP])
Zenpep®
|
4 participants
|
—
|
|
Question 6 (Previous Pancreatic Enzyme Product [PEP])
Creon®
|
9 participants
|
—
|
|
Question 6 (Previous Pancreatic Enzyme Product [PEP])
Ultrase®
|
1 participants
|
—
|
|
Question 6 (Previous Pancreatic Enzyme Product [PEP])
Pancrecarb®
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 10 in first and second treatment periods, end of study (Day 21)Population: ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire on and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.
Average daily number of stools of each participant was calculated from frequency of stools by the participant per day. Average daily number of stools during the first treatment period, second treatment period and end of study for total participants was summarized.
Outcome measures
| Measure |
EUR-1008 (APT-1008) in Apple Juice
n=12 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
EUR-1008 (APT-1008) in Apple Sauce
n=12 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
|---|---|---|
|
Daily Number of Stools
|
2.76 average number of stools per day
Standard Deviation 0.771
|
2.44 average number of stools per day
Standard Deviation 0.766
|
SECONDARY outcome
Timeframe: Up to Day 10 in first and second treatment periods, end of study (Day 21)Population: ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.
Stool consistency was categorized as hard, formed/normal, soft and diarrhea. Average number of stools categorized as per consistency of each participant was calculated from number of stools of specific consistency by the participant per day. Average number of stools categorized as per consistency during the first treatment period, second treatment period and end of study for total participants was summarized.
Outcome measures
| Measure |
EUR-1008 (APT-1008) in Apple Juice
n=12 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
EUR-1008 (APT-1008) in Apple Sauce
n=12 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
|---|---|---|
|
Number of Stools Categorized as Per Consistency
Hard
|
0.04 average number of stools per day
Standard Deviation 0.089
|
0.14 average number of stools per day
Standard Deviation 0.184
|
|
Number of Stools Categorized as Per Consistency
Normal
|
1.77 average number of stools per day
Standard Deviation 0.864
|
1.37 average number of stools per day
Standard Deviation 0.770
|
|
Number of Stools Categorized as Per Consistency
Soft
|
0.62 average number of stools per day
Standard Deviation 0.710
|
0.83 average number of stools per day
Standard Deviation 0.813
|
|
Number of Stools Categorized as Per Consistency
Diarrhea
|
0.24 average number of stools per day
Standard Deviation 0.527
|
0.07 average number of stools per day
Standard Deviation 0.135
|
SECONDARY outcome
Timeframe: Up to Day 10 in first and second treatment periods, end of study (Day 21)Population: ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.
Average number of stools with signs of blood and visible oil or grease of each participant was calculated from number of stools with signs of blood and visible oil or grease by the participant per day. Average number of stools with signs of blood and visible oil or grease during the first treatment period, second treatment period and end of study for total participants was summarized.
Outcome measures
| Measure |
EUR-1008 (APT-1008) in Apple Juice
n=12 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
EUR-1008 (APT-1008) in Apple Sauce
n=12 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
|---|---|---|
|
Number of Stools With Signs of Blood and Visible Oil or Grease
With blood
|
0 average number of stools per day
Standard Deviation 0
|
0.01 average number of stools per day
Standard Deviation 0.047
|
|
Number of Stools With Signs of Blood and Visible Oil or Grease
With visible oil or grease
|
0.09 average number of stools per day
Standard Deviation 0.191
|
0.17 average number of stools per day
Standard Deviation 0.368
|
SECONDARY outcome
Timeframe: Up to Day 10 in first and second treatment periods, end of study (Day 21)Population: ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.
Bloating is swelling of the intestinal tract caused by excessive gas formation. Symptoms of bloating were classified by severity as 0=none, 1=mild (no impairment of daily activities), 2=moderate (slight impairment of daily activities), and 3=severe (unable to perform daily activities). Average number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Average number of symptoms during the first treatment period, second treatment period and end of study for total participants was summarized.
Outcome measures
| Measure |
EUR-1008 (APT-1008) in Apple Juice
n=12 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
EUR-1008 (APT-1008) in Apple Sauce
n=12 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
|---|---|---|
|
Number of Abdominal Symptoms: Bloating
Mild Bloating
|
0.22 average number of bloating per day
Standard Deviation 0.632
|
0.26 average number of bloating per day
Standard Deviation 0.857
|
|
Number of Abdominal Symptoms: Bloating
Moderate Bloating
|
0 average number of bloating per day
Standard Deviation 0
|
0 average number of bloating per day
Standard Deviation 0
|
|
Number of Abdominal Symptoms: Bloating
Severe Bloating
|
0 average number of bloating per day
Standard Deviation 0
|
0 average number of bloating per day
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Up to Day 10 in first and second treatment periods, end of study (Day 21)Population: ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.
Flatulence is presence of excessive gas in the digestive tract. Symptoms of flatulence were classified by severity as 0=none, 1=mild (no impairment of daily activities), 2=moderate (slight impairment of daily activities), and 3=severe (unable to perform daily activities). Average number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Average number of symptoms during the first treatment period, second treatment period and end of study for total participants was summarized.
Outcome measures
| Measure |
EUR-1008 (APT-1008) in Apple Juice
n=12 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
EUR-1008 (APT-1008) in Apple Sauce
n=12 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
|---|---|---|
|
Number of Abdominal Symptoms: Flatulence
Mild Flatulence
|
1.0 average number of flatulence per day
Standard Deviation 1.583
|
0.62 average number of flatulence per day
Standard Deviation 0.869
|
|
Number of Abdominal Symptoms: Flatulence
Moderate Flatulence
|
0.31 average number of flatulence per day
Standard Deviation 0.559
|
0.32 average number of flatulence per day
Standard Deviation 0.670
|
|
Number of Abdominal Symptoms: Flatulence
Severe Flatulence
|
0.04 average number of flatulence per day
Standard Deviation 0.144
|
0 average number of flatulence per day
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Up to Day 10 in first and second treatment periods, end of study (Day 21)Population: ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.
Symptoms of pain was classified by severity as 0=none, 1=mild (no impairment of daily activities), 2=moderate (slight impairment of daily activities), and 3=severe (unable to perform daily activities). Average number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Average number of symptoms during the first treatment period, second treatment period and end of study for total participants was summarized.
Outcome measures
| Measure |
EUR-1008 (APT-1008) in Apple Juice
n=12 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
EUR-1008 (APT-1008) in Apple Sauce
n=12 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
|---|---|---|
|
Number of Abdominal Pain Symptoms
Mild Abdominal Pain
|
0.10 average number of pain symptoms per day
Standard Deviation 0.259
|
0.13 average number of pain symptoms per day
Standard Deviation 0.343
|
|
Number of Abdominal Pain Symptoms
Moderate Abdominal Pain
|
0.09 average number of pain symptoms per day
Standard Deviation 0.238
|
0.07 average number of pain symptoms per day
Standard Deviation 0.231
|
|
Number of Abdominal Pain Symptoms
Severe Abdominal Pain
|
0 average number of pain symptoms per day
Standard Deviation 0
|
0 average number of pain symptoms per day
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline up to end of study (Day 21)Population: Data was reported in individual participant listings but not statistically summarized for analysis as planned.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to end of study (Day 21)Population: Safety population included all participants who received at least 1 dose of study medication.
Safety assessed by the presence of lesions observed during a physical examination at each visit. Severity of lesions measured by investigator's assessment using the following scale: mild = asymptomatic or mild symptoms and treatment not indicated; moderate = moderate pain but not interfering with oral intake, modified diet indicated; severe = severe pain, interfering with oral intake and life threatening or fatal.
Outcome measures
| Measure |
EUR-1008 (APT-1008) in Apple Juice
n=12 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
EUR-1008 (APT-1008) in Apple Sauce
n=15 Participants
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
|---|---|---|
|
Number of Participants With Abnormal Findings With Respect to Oral Mucosa
|
0 participants
|
0 participants
|
Adverse Events
Zenpep®
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
EUR-1008 (APT-1008) in Apple Juice
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
EUR-1008 (APT-1008) in Apple Sauce
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zenpep®
n=15 participants at risk
Zenpep® 5,000 from open capsule, mixed with a small amount of apple sauce, orally daily in the screening period for 10 days.
|
EUR-1008 (APT-1008) in Apple Juice
n=12 participants at risk
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
EUR-1008 (APT-1008) in Apple Sauce
n=15 participants at risk
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
40.0%
6/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
8.3%
1/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
33.3%
5/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Gastrointestinal disorders
Abdominal pain
|
26.7%
4/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
25.0%
3/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
26.7%
4/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Gastrointestinal disorders
Abdominal distension
|
13.3%
2/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
25.0%
3/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
13.3%
2/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
3/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
16.7%
2/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Gastrointestinal disorders
Steatorrhoea
|
20.0%
3/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
16.7%
2/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
26.7%
4/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Gastrointestinal disorders
Teething
|
13.3%
2/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
8.3%
1/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
13.3%
2/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
13.3%
2/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
16.7%
2/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
40.0%
6/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
8.3%
1/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
13.3%
2/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
16.7%
2/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
20.0%
3/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Gastrointestinal disorders
Frequent bowel movements
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Gastrointestinal disorders
Infantile spitting up
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Infections and infestations
Otitis media
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Congenital, familial and genetic disorders
Cystic fibrosis lung
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Nervous system disorders
Drooling
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
8.3%
1/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
|
Infections and infestations
Pseudomonas infection
|
6.7%
1/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/12 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
0.00%
0/15 • Baseline up to end of study (Day 21)
Adverse event (AE): any untoward medical occurrence regardless of causal relationship to study drug. Serious AE: any event resulting in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was congenital anomaly/birth defect. Participants at risk in EUR-1008 (APT-1008) in Apple Juice: 12
|
Additional Information
Robert Winkler, MD, VP, Clinical Development and Operations
Aptalis Pharma US, Inc.
Phone: 1-800-472-2634
Results disclosure agreements
- Principal investigator is a sponsor employee Restrictions vary in accordance with each agreement with the individual investigators. Sponsor will allow publication after a multi-center publication has been published or after an agreed period of time if no such multi-center publication is submitted for publication. Sponsor can ask that Sponsor's confidential information be removed from any publication and can defer publication for a period of time to allow for Sponsor to obtain patent or other intellectual property right protection.
- Publication restrictions are in place
Restriction type: OTHER