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A study to determine the safety, effectiveness, and acceptability of 2 methods of administration of EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) 3,000 lipase units capsule, a pancreatic enzyme product (PEP), in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). This study is sponsored by Aptalis Pharma (formerly Eurand).
This is a multicenter, randomized, open-label, crossover study in pediatric participants with EPI due to CF. The study will be carried out in infants between 1 and 12 months of age.
The study comprises of a screening period (up to 10 days) followed by 2 treatment periods (10 days each). During the screening period, all participants will be administered Zenpep® 5,000 (pancrelipase) mixed with a small amount of apple sauce. Once determined eligible for participation, participants will be randomized into 1 of 2 treatment sequences. Each sequence corresponds to taking one treatment in the first period and the other treatment in the second period, and were administered EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) 3,000 lipase units capsule either mixed with apple juice using a syringe nurser or apple sauce using a spoon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUR-1008 (APT-1008) in Apple Juice | Experimental |
| |
| EUR-1008 (APT-1008) in Apple Sauce | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUR-1008 (APT-1008) | Drug | EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice, will be given orally daily using a syringe nurser at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period. Total dose will not exceed 10,000 lipase units per kilogram (kg) of body weight per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Difference for Acceptability of Treatment | 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). | Baseline up to end of study (Day 21) |
| Question 6 (Previous Pancreatic Enzyme Product [PEP]) | 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Number of Stools | 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. | Up to Day 10 in first and second treatment periods, end of study (Day 21) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aptalis Medical Information | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Clinic | Jacksonville | Florida | 32250 | United States | ||
| Children's Lung Specialists Ltd. |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Treatment Period |
|
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|
|
| EUR-1008 (APT-1008) | Drug | EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce, will be given orally daily using a spoon at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period. Total dose will not exceed 10,000 lipase units per kg of body weight per day. |
|
|
| Number of Stools Categorized as Per Consistency | 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. | Up to Day 10 in first and second treatment periods, end of study (Day 21) |
| Number of Stools With Signs of Blood and Visible Oil or Grease | 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. | Up to Day 10 in first and second treatment periods, end of study (Day 21) |
| Number of Abdominal Symptoms: Bloating | 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. | Up to Day 10 in first and second treatment periods, end of study (Day 21) |
| Number of Abdominal Symptoms: Flatulence | 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. | Up to Day 10 in first and second treatment periods, end of study (Day 21) |
| Number of Abdominal Pain Symptoms | 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. | Up to Day 10 in first and second treatment periods, end of study (Day 21) |
| Number of Participants With Abnormal Clinical Laboratory and Vital Signs Findings | Baseline up to end of study (Day 21) |
| Number of Participants With Abnormal Findings With Respect to Oral Mucosa | 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. | Baseline up to end of study (Day 21) |
| Las Vegas |
| Nevada |
| 89107 |
| United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Cystic Fibrosis Care Center | Houston | Texas | 77030 | United States |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
| Second Treatment Period |
|
Safety analysis population included all participants who received at least 1 dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Average Daily Number of Stools | 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 screening period for total participants was summarized. Number of participants evaluable for this baseline characteristic was 12. | Mean | Standard Deviation | average number of stools per day |
| |||||||||||||||||
| Number of Stools Categorized as Per Consistency | 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 screening period for total participants was summarized. Number of participants evaluable for this baseline characteristic was 12. | Mean | Standard Deviation | average number of stools per day |
| |||||||||||||||||
| Number of Stools With Signs of Blood and Visible Oil or Grease | 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 stools with signs of blood and visible oil or grease during the screening period for total participants was summarized. Number of participants evaluable for this baseline characteristic was 12. | Mean | Standard Deviation | average number of stools per day |
| |||||||||||||||||
| Number of Abdominal Symptoms: Bloating | 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 screening period for total participants was summarized. Number of participants evaluable for this baseline characteristic was 12. | Mean | Standard Deviation | average number of bloating per day |
| |||||||||||||||||
| Number of Abdominal Symptoms: Flatulence | 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 screening period for total participants was summarized. Number of participants evaluable for this baseline characteristic was 12. | Mean | Standard Deviation | average number of flatulence per day |
| |||||||||||||||||
| Number of Abdominal Pain Symptoms | 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 screening period for total participants was summarized. Number of participants evaluable for this baseline characteristic was 12. | Mean | Standard Deviation | average number of pain symptoms per day |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Daily Number of Stools | 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. | 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. | Posted | Mean | Standard Deviation | average number of stools per day | Up to Day 10 in first and second treatment periods, end of study (Day 21) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Stools Categorized as Per Consistency | 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. | 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. | Posted | Mean | Standard Deviation | average number of stools per day | Up to Day 10 in first and second treatment periods, end of study (Day 21) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Stools With Signs of Blood and Visible Oil or Grease | 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. | 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. | Posted | Mean | Standard Deviation | average number of stools per day | Up to Day 10 in first and second treatment periods, end of study (Day 21) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Abdominal Symptoms: Bloating | 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. | 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. | Posted | Mean | Standard Deviation | average number of bloating per day | Up to Day 10 in first and second treatment periods, end of study (Day 21) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Abdominal Symptoms: Flatulence | 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. | 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. | Posted | Mean | Standard Deviation | average number of flatulence per day | Up to Day 10 in first and second treatment periods, end of study (Day 21) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Abdominal Pain Symptoms | 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. | 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. | Posted | Mean | Standard Deviation | average number of pain symptoms per day | Up to Day 10 in first and second treatment periods, end of study (Day 21) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Clinical Laboratory and Vital Signs Findings | Data was reported in individual participant listings but not statistically summarized for analysis as planned. | Posted | Baseline up to end of study (Day 21) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Findings With Respect to Oral Mucosa | 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. | Safety population included all participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to end of study (Day 21) |
| |||||||||||||||||||||||||||||||
| Primary | Treatment Difference for Acceptability of Treatment | 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). | 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. | Posted | Median | Full Range | units on a scale | Baseline up to end of study (Day 21) |
| ||||||||||||||||||||||||||||||
| Primary | Question 6 (Previous Pancreatic Enzyme Product [PEP]) | 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. | Safety analysis population included all participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline |
|
|
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
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zenpep® | Zenpep® 5,000 from open capsule, mixed with a small amount of apple sauce, orally daily in the screening period for 10 days. | 0 | 15 | 11 | 15 | ||
| EG001 | EUR-1008 (APT-1008) in Apple Juice | 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. | 0 | 12 | 10 | 12 | ||
| EG002 | 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. | 0 | 15 | 14 | 15 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flatulence | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Steatorrhoea | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Faeces hard | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Infantile spitting up | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cystic fibrosis lung | Congenital, familial and genetic disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Non-systematic Assessment |
| |
| Drooling | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA (13.0) | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Winkler, MD, VP, Clinical Development and Operations | Aptalis Pharma US, Inc. | 1-800-472-2634 |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D010188 | Exocrine Pancreatic Insufficiency |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020799 | Pancrelipase |
| ID | Term |
|---|---|
| D008049 | Lipase |
| D002265 | Carboxylic Ester Hydrolases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010184 | Pancreatic Extracts |
| D014020 | Tissue Extracts |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Title |
|---|
| Measurements |
|---|
|
| Soft |
|
| Diarrhea |
|
| Title |
|---|
| Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Severe Bloating |
|
| Title | Measurements |
|---|---|
|
| Severe Flatulence |
|
| Title | Measurements |
|---|---|
|
| Severe Abdominal Pain |
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 | EUR-1008 (APT-1008) in Apple Sauce | EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsules) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily with dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period. |
|
|
|