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The primary efficacy objective of this study is to evaluate the difference in coefficient of fat absorption (CFA) of participants treated with high dose EUR-1008 (APT-1008) versus low dose of EUR-1008 (APT-1008) in the treatment of signs and symptoms of malabsorption in participants with EPI associated with CP. This study is sponsored by Aptalis Pharma (formerly Eurand).
After screening, eligible participants will start the placebo baseline ambulatory phase (4 days). On day 5, they will be hospitalized for three to five days, to undergo a "baseline" 72-hour CFA determination under a controlled diet and using a stool marker to indicate the beginning and end of the controlled diet period, while they continue receiving placebo treatment. At the end of the placebo baseline phase, participants will be randomized to a "high dose followed by a low dose" or to a "low dose followed by a high dose" EUR-1008 (APT-1008) dose sequence and proceed to the first crossover (treatment) phase. Each crossover (treatment) phase will consist of a stabilization period for six days at home, followed by a hospitalization of three to five days to undergo a 72-hour CFA determination using a controlled diet and using a stool marker to indicate the beginning and end of the controlled diet period.
Participants will immediately proceed from the first crossover (treatment) phase to the second without a washout period or return-to-baseline period in between phases. Participants will be stabilized at home for 6 days. Any residual lipase from the prior treatment phase is likely to be a negligible influence on the subsequent CFA determination because participants will be taking the new dose level (high or low) for six days before the beginning of sample collection for a new CFA. This interval is more than enough time for the CFA to be reflective of only the new dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| EUR-1008 (APT-1008) High Dose | Experimental |
| |
| EUR-1008 (APT-1008) Low Dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo matching to EUR-1008 (APT-1008) capsules orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which will then be randomized to either high dose or low dose of EUR-1008 (APT-1008). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Coefficient of Fat Absorption (CFA) of Participants Treated With High Dose EUR-1008 and Low Dose EUR-1008 | Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for the 3 to 5 days of hospital treatment in first and second intervention periods. | 3 to 5 days of hospital treatment in first and second intervention periods |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Placebo Baseline in Percent Coefficient of Fat Absorption (CFA) in High Dose EUR-1008 and Low Dose EUR-1008 During Hospital Treatment | Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods. |
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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 |
|---|---|---|---|---|---|---|
| Woodland International Research Group | Little Rock | Arkansas | 72211 | United States | ||
| HealthCare Partners Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Baseline | Placebo matched to EUR-1008 (APT-1008) capsules orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008). |
| FG001 | EUR-1008 (APT-1008) High Dose, Then Low Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Placebo Run-in Phase |
|
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| EUR-1008 (APT-1008) High Dose | Drug | EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units will be given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period. |
|
|
| EUR-1008 (APT-1008) Low Dose | Drug | EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units will be given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period. |
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| Baseline, 3 to 5 days of hospital treatment in first and second intervention periods |
| Change From Placebo Baseline in Percent Coefficient of Nitrogen Absorption (CNA) During Hospital Treatment | Percent CNA was calculated as [(nitrogen intake - nitrogen excretion)/nitrogen intake]*100 , determined in the stools collected during the 72-hour CNA determination period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods. | Baseline, 3 to 5 days of hospital treatment in first and second intervention periods |
| Change From Placebo Baseline in Weight at End of Each Treatment Period | Mean change from baseline in weight was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods. | Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods) |
| Change From Placebo Baseline in Body Mass Index (BMI) at End of Treatment | BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). Mean change from baseline in BMI was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods. | Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods) |
| Los Angeles |
| California |
| 90015 |
| United States |
| University of Florida, General Clinical Research Center | Gainesville | Florida | 32610 | United States |
| Advanced Medical Research Center | Port Orange | Florida | 32127 | United States |
| Veterans Affairs Edward Jr. Hines Hospital, Building #1 | Hines | Illinois | 60141 | United States |
| University of Iowa Hospitals and Clinics | Iowa Ctiy | Iowa | 52242 | United States |
| University of Kentucky, Medical Center, Department of Gastroenterology | Lexington | Kentucky | 40536 | United States |
| University of Louisville, Carmichael Building | Louisville | Kentucky | 40202 | United States |
| University of Missouri Health Care | Columbia | Missouri | 65212 | United States |
| Dipartmento di Malattie dell' apparato digerente e Medicina Interna- Unita Operativa di MedicinaInterna Corinaldesi Azienda Ospedaliero- Universitaria Policlinico Sant'Orsola Malpighi Via Massarenti | Massarenti | Bologna | 9-40138 | Italy |
| Istituto Clinico Humanitas - Universita' Di Milano Via Manzoni | Rozzano | Milano | 20089 | Italy |
| Istituto di Clinica Chirurgica (Ensoscopia Digestive Chirurgica) Policlinico Gemelli-Universita Cattolica del Sacro Cuore | Largo Agostino Gemelli | Roma | 8 00168 | Italy |
| Centro Richerche Cliniche di Verona | Le Ludovico Scuro | Verona | 10 37134 | Italy |
| Department of Therapy and Family Medicine of the Facility of Post graduate Education of Crimea State Medical University named after S.I. Georglyevskyy Republic Clinical Hospital named after M.O. Semashko | Simferopol | Autonomous Republic of Crimea | 95017 | Ukraine |
| Department of Internal Medicine No 2 of Donetsk State University named after M. Gorkly, City Clinical Hospital No 3 | Donetsk | Donetsk Oblast | 83017 | Ukraine |
| Department of Liver and Gastrointestinal Tract Disease Institute of Therapy named after L.T. Maylaya of Academy of Medical Sciences of the Ukraine | Kharkiv | Kharklv | 61039 | Ukraine |
| Department of Faculty Therapy No 1 with the Course of Postgraduate Training of Physicians for Gastroenterology and Endoscopy, National Medical University named after O.O. Bogomolets, City Hospital No 18 | Kyiv | Kylv | 01030 | Ukraine |
| General Therapy Clinic, Military Clinical Hospital of Ministry of Defense of Ukraine 18 | Kyiv | Kylv | 01133 | Ukraine |
EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment. |
| FG002 | EUR-1008 (APT-1008) Low Dose, Then High Dose | EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment. |
| COMPLETED |
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| NOT COMPLETED |
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| First Intervention Period |
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| Second Intervention Period |
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Full analysis set (FAS) included all participants who received at least 1 dose of the study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes participants who received placebo, EUR-1008 (APT-1008) high dose first and EUR-1008 (APT-1008) low dose 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 | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Body Weight | Mean | Standard Deviation | kilogram (kg) |
| |||||||||||||||||
| Body Mass Index (BMI) | BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). | Mean | Standard Deviation | kg/m^2 |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Coefficient of Fat Absorption (CFA) of Participants Treated With High Dose EUR-1008 and Low Dose EUR-1008 | Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for the 3 to 5 days of hospital treatment in first and second intervention periods. | FAS included all participants who received at least 1 dose of the study medication. Here "N" (number of participants analyzed) signifies those participants for whom the CFA values were available. | Posted | Mean | Standard Deviation | percent CFA | 3 to 5 days of hospital treatment in first and second intervention periods |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Placebo Baseline in Percent Coefficient of Fat Absorption (CFA) in High Dose EUR-1008 and Low Dose EUR-1008 During Hospital Treatment | Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods. | FAS included all participants who received at least 1 dose of the study medication. Here "N" (number of participants analyzed) signifies those participants for whom the CFA values were available. | Posted | Mean | Standard Deviation | percent CFA | Baseline, 3 to 5 days of hospital treatment in first and second intervention periods |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Placebo Baseline in Percent Coefficient of Nitrogen Absorption (CNA) During Hospital Treatment | Percent CNA was calculated as [(nitrogen intake - nitrogen excretion)/nitrogen intake]*100 , determined in the stools collected during the 72-hour CNA determination period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods. | FAS included all participants who received at least one dose of the study drug. Here "N" (number of participants analyzed) represents number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percent CNA | Baseline, 3 to 5 days of hospital treatment in first and second intervention periods |
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| Secondary | Change From Placebo Baseline in Weight at End of Each Treatment Period | Mean change from baseline in weight was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods. | FAS included all participants who received at least one dose of the study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | kilogram (kg) | Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Placebo Baseline in Body Mass Index (BMI) at End of Treatment | BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). Mean change from baseline in BMI was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods. | FAS included all participants who received at least one dose of the study medication. Here "N" (number of participants analyzed) represents number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods) |
|
Baseline up to final follow-up visit (14 days after end of study)
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.
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 | Placebo Baseline | Placebo matched to EUR-1008 (APT-1008) capsule orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008). | 2 | 82 | 34 | 82 | ||
| EG001 | EUR-1008 (APT-1008) Low Dose | EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period. | 2 | 74 | 28 | 74 | ||
| EG002 | EUR-1008 (APT-1008) High Dose | EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period. | 2 | 75 | 31 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Renal injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Steatorrhoea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Blood glucose abnormal | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Blood uric acid decreased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Protein induced by vitamin K absence or antagonist II increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Vitamin A deficiency | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Vitamin E deficiency | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Breast tenderness | Reproductive system and breast disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Sinus operation | Surgical and medical procedures | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.0) | 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 |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D010188 | Exocrine Pancreatic Insufficiency |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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
| OG002 | EUR-1008 (APT-1008) High Dose | EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period. |
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| OG002 | EUR-1008 (APT-1008) High Dose | EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period. |
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