Trial Outcomes & Findings for Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency (NCT NCT00981214)
NCT ID: NCT00981214
Last Updated: 2017-03-16
Results Overview
Responders were defined as those participants without steatorrhea (defined as less than 30 percent (%) fecal fat content) and without signs and symptoms of malabsorption after 1 week of treatment with study medication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
19 participants
Primary outcome timeframe
Day 11
Results posted on
2017-03-16
Participant Flow
Participant milestones
| Measure |
EUR-1008 (APT-1008)
EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
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|---|---|
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Overall Study
STARTED
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19
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Overall Study
COMPLETED
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19
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
Baseline characteristics by cohort
| Measure |
EUR-1008 (APT-1008)
n=19 Participants
EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
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Age, Continuous
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3.9 years
STANDARD_DEVIATION 1.58 • n=5 Participants
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Sex: Female, Male
Female
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7 Participants
n=5 Participants
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Sex: Female, Male
Male
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12 Participants
n=5 Participants
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Percentage of Participants Who Were Responders
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52.6 percentage of participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 11Population: Analysis population included all participants who received at least 1 dose of study medication.
Responders were defined as those participants without steatorrhea (defined as less than 30 percent (%) fecal fat content) and without signs and symptoms of malabsorption after 1 week of treatment with study medication.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=19 Participants
EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
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Percentage of Participants Who Were Responders After 1 Week of Treatment With Study Medication
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68.4 percentage of participants
Interval 43.4 to 87.4
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PRIMARY outcome
Timeframe: Day 18 (end of treatment)Population: Analysis population included all participants who received at least 1 dose of study medication.
Responders were defined as those participants without steatorrhea (defined as less than 30% fecal fat content) and without signs and symptoms of malabsorption after 2 weeks of treatment with study medication.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=19 Participants
EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
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Percentage of Participants Who Were Responders After 2 Weeks of Treatment With Study Medication
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57.9 percentage of participants
Interval 33.5 to 79.7
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SECONDARY outcome
Timeframe: Baseline, Day 12, 19Population: Analysis population included all participants who received at least 1 dose of study medication.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=19 Participants
EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
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Change From Baseline in Weight at Day 12, 19
Baseline
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16.60 kilogram
Standard Deviation 3.843
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Change From Baseline in Weight at Day 12, 19
Change at Day 12
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0.15 kilogram
Standard Deviation 0.401
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Change From Baseline in Weight at Day 12, 19
Change at Day 19
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0.03 kilogram
Standard Deviation 0.529
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SECONDARY outcome
Timeframe: Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)Population: Analysis population included all participants who received at least 1 dose of study medication.
Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools at each period for total participants was summarized.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=19 Participants
EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
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Mean Daily Number of Stools
Baseline
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1.82 stools per day
Standard Error 0.787
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Mean Daily Number of Stools
Dose stabilization period
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1.64 stools per day
Standard Error 0.722
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Mean Daily Number of Stools
Treatment period
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1.45 stools per day
Standard Error 0.548
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SECONDARY outcome
Timeframe: Baseline, Day 5 up to Day 11 (dose stabilization period) and Day 12 up to Day 18 (treatment period)Population: Analysis population included all participants who received at least 1 dose of study medication.
Stool consistency was categorized as hard, formed/normal, soft, watery or overt diarrhea. Percentage of stools of a specific consistency of each participant was calculated as the number of stools with a specific consistency relative to the total number of stools during the collection period. Mean percentage of stool with specific consistency at each period for total participants was summarized.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=19 Participants
EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
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Percentage of Stool Categorized by Consistency
Hard: Baseline
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5.45 percentage of stools
Standard Deviation 15.782
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Percentage of Stool Categorized by Consistency
Hard: Dose stabilization period
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4.59 percentage of stools
Standard Deviation 12.694
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Percentage of Stool Categorized by Consistency
Hard: Treatment period
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3.78 percentage of stools
Standard Deviation 8.624
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Percentage of Stool Categorized by Consistency
Formed/Normal: Baseline
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59.46 percentage of stools
Standard Deviation 37.956
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Percentage of Stool Categorized by Consistency
Formed/Normal: Dose stabilization period
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58.20 percentage of stools
Standard Deviation 33.675
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Percentage of Stool Categorized by Consistency
Formed/Normal: Treatment period
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59.38 percentage of stools
Standard Deviation 35.671
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Percentage of Stool Categorized by Consistency
Soft: Baseline
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30.18 percentage of stools
Standard Deviation 33.382
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Percentage of Stool Categorized by Consistency
Soft: Dose stabilization period
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32.32 percentage of stools
Standard Deviation 28.283
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Percentage of Stool Categorized by Consistency
Soft: Treatment period
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33.15 percentage of stools
Standard Deviation 31.460
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Percentage of Stool Categorized by Consistency
Watery: Baseline
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4.54 percentage of stools
Standard Deviation 8.339
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Percentage of Stool Categorized by Consistency
Watery: Dose stabilization period
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3.03 percentage of stools
Standard Deviation 6.988
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Percentage of Stool Categorized by Consistency
Watery: Treatment period
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3.16 percentage of stools
Standard Deviation 6.561
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Percentage of Stool Categorized by Consistency
Overt Diarrhea: Baseline
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0.38 percentage of stools
Standard Deviation 1.639
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Percentage of Stool Categorized by Consistency
Overt Diarrhea: Dose stabilization period
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1.86 percentage of stools
Standard Deviation 8.097
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Percentage of Stool Categorized by Consistency
Overt Diarrhea: Treatment period
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0.53 percentage of stools
Standard Deviation 2.294
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SECONDARY outcome
Timeframe: Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)Population: Analysis population included all participants who received at least 1 dose of study medication.
Bloating is swelling of the intestinal tract caused by excessive gas formation. Symptoms of bloating were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Mean number of symptoms at each period for total participants was summarized.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=19 Participants
EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
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Mean Number of Abdominal Symptoms: Bloating
Mild: Baseline
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0.11 bloatings per day
Standard Deviation 0.326
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Mean Number of Abdominal Symptoms: Bloating
Mild: Dose stabilization period
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0.14 bloatings per day
Standard Deviation 0.391
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Mean Number of Abdominal Symptoms: Bloating
Mild: Treatment period
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0.08 bloatings per day
Standard Deviation 0.230
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Mean Number of Abdominal Symptoms: Bloating
Moderate: Baseline
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0.06 bloatings per day
Standard Deviation 0.159
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Mean Number of Abdominal Symptoms: Bloating
Moderate: Dose stabilization period
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0.02 bloatings per day
Standard Deviation 0.098
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Mean Number of Abdominal Symptoms: Bloating
Moderate: Treatment period
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0.01 bloatings per day
Standard Deviation 0.029
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Mean Number of Abdominal Symptoms: Bloating
Severe: Baseline
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0.04 bloatings per day
Standard Deviation 0.172
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Mean Number of Abdominal Symptoms: Bloating
Severe: Dose stabilization period
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0.00 bloatings per day
Standard Deviation 0.000
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Mean Number of Abdominal Symptoms: Bloating
Severe: Treatment period
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0.00 bloatings per day
Standard Deviation 0.000
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SECONDARY outcome
Timeframe: Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)Population: Analysis population included all participants who received at least 1 dose of study medication.
Flatulence is presence of excessive gas in the digestive tract. Symptoms of flatulence was classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Mean number of symptoms at each period for total participants was summarized.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=19 Participants
EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
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|---|---|
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Mean Number of Abdominal Symptoms: Flatulence
Mild: Baseline
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0.13 flatulences per day
Standard Deviation 0.262
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Mean Number of Abdominal Symptoms: Flatulence
Mild: Dose stabilization period
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0.20 flatulences per day
Standard Deviation 0.283
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Mean Number of Abdominal Symptoms: Flatulence
Mild: Treatment period
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0.08 flatulences per day
Standard Deviation 0.215
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Mean Number of Abdominal Symptoms: Flatulence
Moderate: Baseline
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0.06 flatulences per day
Standard Deviation 0.109
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Mean Number of Abdominal Symptoms: Flatulence
Moderate: Dose stabilization period
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0.06 flatulences per day
Standard Deviation 0.204
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Mean Number of Abdominal Symptoms: Flatulence
Moderate: Treatment period
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0.00 flatulences per day
Standard Deviation 0.000
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Mean Number of Abdominal Symptoms: Flatulence
Severe: Baseline
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0.04 flatulences per day
Standard Deviation 0.119
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Mean Number of Abdominal Symptoms: Flatulence
Severe: Dose stabilization period
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0.02 flatulences per day
Standard Deviation 0.045
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Mean Number of Abdominal Symptoms: Flatulence
Severe: Treatment period
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0.09 flatulences per day
Standard Deviation 0.393
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SECONDARY outcome
Timeframe: Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)Population: Analysis population set included all participants who received at least 1 dose of study.
Symptoms of pain was classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Mean number of symptoms at each period for total participants was summarized.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=19 Participants
EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
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Mean Number of Pain Symptoms
Mild: Baseline
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0.09 pain symptoms per day
Standard Deviation 0.210
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Mean Number of Pain Symptoms
Mild: Dose stabilization period
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0.14 pain symptoms per day
Standard Deviation 0.321
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Mean Number of Pain Symptoms
Mild: Treatment period
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0.07 pain symptoms per day
Standard Deviation 0.204
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Mean Number of Pain Symptoms
Moderate: Baseline
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0.04 pain symptoms per day
Standard Deviation 0.118
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Mean Number of Pain Symptoms
Moderate: Dose stabilization period
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0.08 pain symptoms per day
Standard Deviation 0.204
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Mean Number of Pain Symptoms
Moderate: Treatment period
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0.00 pain symptoms per day
Standard Deviation 0.000
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Mean Number of Pain Symptoms
Severe: Baseline
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0.00 pain symptoms per day
Standard Deviation 0.000
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Mean Number of Pain Symptoms
Severe: Dose stabilization period
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0.05 pain symptoms per day
Standard Deviation 0.201
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Mean Number of Pain Symptoms
Severe: Treatment period
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0.00 pain symptoms per day
Standard Deviation 0.000
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SECONDARY outcome
Timeframe: Day 19 (end of study)Population: Analysis population set included all participants who received at least 1 dose of study.
Clinical symptoms of exocrine pancreatic insufficiency (EPI) were assessed by the physician and parent or guardian to determine if the participant showed improvement in symptoms of EPI at end of study after the dose stabilization period. EPI is a syndrome characterized by clinical symptoms of poor absorption of fats, proteins, and to a lesser extent, carbohydrates, which manifests primarily in patients with cystic fibrosis. Number of participants with improvement in clinical symptoms was reported.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=19 Participants
EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
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Physician's and Parent's or Legal Guardians Assessment of Improvement in Clinical Symptoms
Physician assessment
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7 participants
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Physician's and Parent's or Legal Guardians Assessment of Improvement in Clinical Symptoms
Parent/guardian assessment
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9 participants
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SECONDARY outcome
Timeframe: Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)Population: Analysis population set included all participants who received at least 1 dose of study.
Mean percentage of stools with blood at each period for total participants was summarized.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=19 Participants
EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
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|---|---|
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Percentage of Blood in Stool
Baseline
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0 percentage of stools
Standard Deviation 0
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Percentage of Blood in Stool
Dose stabilization period
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0 percentage of stools
Standard Deviation 0
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Percentage of Blood in Stool
Treatment period
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0 percentage of stools
Standard Deviation 0
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SECONDARY outcome
Timeframe: Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)Population: Analysis population included all participants who received at least 1 dose of study medication.
Mean percentage of oil or grease at each period for total participants was summarized.
Outcome measures
| Measure |
EUR-1008 (APT-1008)
n=19 Participants
EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
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Percentage of Stool With Visible Oil or Grease
Baseline
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11.10 percentage of stools
Standard Deviation 14.433
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Percentage of Stool With Visible Oil or Grease
Dose stabilization period
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8.98 percentage of stools
Standard Deviation 11.879
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Percentage of Stool With Visible Oil or Grease
Treatment period
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4.73 percentage of stools
Standard Deviation 7.722
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Adverse Events
EUR-1008 (APT-1008)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EUR-1008 (APT-1008)
n=19 participants at risk
EUR-1008 (APT-1008) Microtabs contained in capsule was administered orally or sprinkled on food. When required, from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
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Infections and infestations
Upper respiratory tract infection
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5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
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Other adverse events
| Measure |
EUR-1008 (APT-1008)
n=19 participants at risk
EUR-1008 (APT-1008) Microtabs contained in capsule was administered orally or sprinkled on food. When required, from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
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Blood and lymphatic system disorders
Lymphadenopathy
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5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
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Eye disorders
Lacrimation increased
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5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
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Gastrointestinal disorders
Abdominal discomfort
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5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
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Gastrointestinal disorders
Abdominal distension
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5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
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Gastrointestinal disorders
Abdominal pain
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26.3%
5/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
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Gastrointestinal disorders
Diarrhoea
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5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
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Gastrointestinal disorders
Faeces discoloured
|
10.5%
2/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Flatulence
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10.5%
2/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Steatorrhoea
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15.8%
3/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
2/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
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General disorders
Pyrexia
|
15.8%
3/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Injury, poisoning and procedural complications
Injury
|
5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Injury, poisoning and procedural complications
Sunburn
|
5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.5%
2/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
5.3%
1/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
15.8%
3/19 • Baseline up to Day 19
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect.
|
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