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This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancrelipase Delayed Release | Drug | 3,000, 6,000 and 12,000 unit Lipase Capsules |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE) | Treatment Emergent Adverse Events are defined as adverse events started at or after the first administration of study drug and include those events started prior to the first administration but which worsened after the first intake. | 10 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Fat (% Fat) | The stool fat content was calculated as percent fat of dry solid weight per bowel movement. Stool fat per patient was derived as mean over three bowel movements sampled (i.e. one sample per day). | Last 3 days in a 10-day treatment period |
| Fat Intake (g) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 11 | Boise | Idaho | United States | |||
| Site 5 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20441244 | Background | Graff GR, McNamara J, Royall J, Caras S, Forssmann K. Safety and tolerability of a new formulation of pancrelipase delayed-release capsules (CREON) in children under seven years of age with exocrine pancreatic insufficiency due to cystic fibrosis: an open-label, multicentre, single-treatment-arm study. Clin Drug Investig. 2010;30(6):351-64. doi: 10.2165/11533390-000000000-00000. |
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Nineteen subjects were consented and 18 subjects were allocated to pancrelipase delayed release capsule. One subject did not meet the fecal elastase requirement and did not receive study medication.
Subjects were recruited in 9 centers in US between April 2009 and June 2009. During the period of screening (Days -21 to Days -7), subjects were evaluated for eligibility. They underwent a short period of up to 7 days on their usual pancreatic enzyme supplementation before receiving the study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pancrelipase Delayed-Release Capsules | Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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The mean daily fat intake was determined as the average of daily fat intake over a 3-day period. |
| Last 3 days in a 10-day treatment period |
| Total Calorie Intake (kcal) | The total calorie intake was determined as the average of total calorie of daily food intake intake over a 3-day period. | Last 3 days in a 10-day treatment period |
| Louisville |
| Kentucky |
| United States |
| Site 9 | Boston | Massachusetts | United States |
| Site 6 | Ann Arbor | Michigan | United States |
| Site 12 | Detroit | Michigan | United States |
| Site 4 | Minneapolis | Minnesota | United States |
| Site 13 | Long Branch | New Jersey | United States |
| Site 8 | Albuquerque | New Mexico | United States |
| Site 1 | Cincinnati | Ohio | United States |
| Site 10 | Oklahoma City | Oklahoma | United States |
| Site 7 | Oklahoma City | Oklahoma | United States |
| Site 3 | Hershey | Pennsylvania | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pancrelipase Delayed-Release Capsules | Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | The Baseline characteristics are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data | Mean | Standard Deviation | months |
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| Sex: Female, Male | The Baseline characteristics are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Stool Fat (% Fat) | The stool fat content was calculated as percent fat of dry solid weight per bowel movement. Stool fat per patient was derived as mean over three bowel movements sampled (i.e. one sample per day). | The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data. | Posted | Mean | Standard Deviation | Percentage of fat | Last 3 days in a 10-day treatment period |
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| Secondary | Fat Intake (g) | The mean daily fat intake was determined as the average of daily fat intake over a 3-day period. | The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data. | Posted | Mean | Standard Deviation | Grams | Last 3 days in a 10-day treatment period |
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| Secondary | Total Calorie Intake (kcal) | The total calorie intake was determined as the average of total calorie of daily food intake intake over a 3-day period. | The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data. | Posted | Mean | Standard Deviation | Kcal | Last 3 days in a 10-day treatment period |
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| Primary | Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE) | Treatment Emergent Adverse Events are defined as adverse events started at or after the first administration of study drug and include those events started prior to the first administration but which worsened after the first intake. | Posted | Number | Participants | 10 Days |
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The adverse events presented were collected from start of drug treatment to the end of the treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pancrelipase Delayed-Release Capsules | Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks. | 0 | 18 | 9 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Irritability | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Skin candida | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Otitis media accute | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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At 60 days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy and allow Sponsor 60 days to review and comment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sven Voet - Global Communication | Solvay Pharmaceuticals | +32 (0)2 509 69 77 | sven.voet@solvay.com |
| 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 |
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| Title | Denominators | Categories | ||||
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