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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004005-10 |
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This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
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| B | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancrelipase Delayed Release | Drug | 24000 unit Capsule |
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| Placebo Comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of Fat Absorption (%) | This coefficient is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of Nitrogen Absorption (%) | This coefficient is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response. | 5 days |
| Total Fat Excretion (Grams) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Days With Formed/Normal Stools. | The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response. | 5 days |
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 | Long Beach | California | United States | |||
| Site 10 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19815466 | Result | Trapnell BC, Maguiness K, Graff GR, Boyd D, Beckmann K, Caras S. Efficacy and safety of Creon 24,000 in subjects with exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 2009 Dec;8(6):370-7. doi: 10.1016/j.jcf.2009.08.008. Epub 2009 Oct 7. |
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Two subjects prematurely withdrew before the randomization (1 withdrew consent and 1 for protocol violation). 32 subjects were randomly allocated to pancrelipase/placebo or placebo/pancrelipase. 1 subject did not complete the second period of the treatment. 1 subject was randomized twice and only the second randomization was used for analyses.
Subjects were recruited in 10 centers in US between November 2007 and January 2008. Before the randomization, subjects were evaluated for eligibility. They underwent a short period of up to 14 days on their usual pancreatic enzyme supplementation. Subjects were to take 4000 lipase units/g fat intake during both cross-over periods.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Pancrelipase | |
| FG001 | Pancrelipase/Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Drug |
Placebo |
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Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response. |
| 5 days |
| Total Stool Weight (Grams) | Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response. | 5 days |
| Stool Frequency | Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response. | 5 days |
| Percentage of Days With no Flatulence. | The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response. | 5 days |
| Percentage of Days With no Abdominal Pain. | The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response. | 5 days |
| Los Angeles |
| California |
| United States |
| Site 13 | San Francisco | California | United States |
| Site 5 | Miami | Florida | United States |
| Site 4 | Orlando | Florida | United States |
| Site 1 | Iowa City | Iowa | United States |
| Site 7 | Louisville | Kentucky | United States |
| Site 17 | Boston | Massachusetts | United States |
| Site 8 | Ann Arbor | Michigan | United States |
| Site 6 | Minneapolis | Minnesota | United States |
| Site 18 | Long Branch | New Jersey | United States |
| Site 16 | Albuquerque | New Mexico | United States |
| Site 19 | Cincinnati | Ohio | United States |
| Site 12 | Dayton | Ohio | United States |
| Site 2 | Toledo | Ohio | United States |
| Site 14 | Oklahoma City | Oklahoma | United States |
| Site 3 | Hershey | Pennsylvania | United States |
| Site 15 | Philadelphia | Pennsylvania | United States |
| Site 9 | Nashville | Tennessee | United States |
| Site 20 | Petrofi | Hungary |
| Site 21 | Jerusalem | Israel |
| Site 22 | Johannesburg | South Africa |
| Site 23 | Barcelona | Spain |
| COMPLETED |
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| NOT COMPLETED |
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| Wash-out Period |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Pancrelipase | |
| BG001 | Pancrelipase/Placebo | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Coefficient of Fat Absorption (%) | This coefficient is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response. | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Percentage | 5 days |
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| Secondary | Coefficient of Nitrogen Absorption (%) | This coefficient is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response. | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Percentage | 5 days |
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| Secondary | Total Fat Excretion (Grams) | Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response. | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Grams | 5 days |
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| Secondary | Total Stool Weight (Grams) | Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response. | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Grams | 5 days |
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| Secondary | Stool Frequency | Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response. | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Number per day | 5 days |
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| Other Pre-specified | Percentage of Days With Formed/Normal Stools. | The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response. | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Percentage of days | 5 days |
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| Secondary | Percentage of Days With no Flatulence. | The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response. | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Percentage of days | 5 days |
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| Secondary | Percentage of Days With no Abdominal Pain. | The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response. | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | Percentage of days | 5 days |
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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 | 0 | 32 | 14 | 32 | |||
| EG001 | Placebo | 0 | 31 | 20 | 31 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Faeces abnormal | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
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| Flatulence, Bloating and Distension | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
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| Gastrointestinal and abdominal pain (Excl oral and throat) | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
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| Physical Examination Procedures | Investigations | MedDRA 8.1 | Non-systematic Assessment |
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| Headaches NEC | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
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| Neurological signs and symptoms NEC | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
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| Coughing and Associated Symptoms | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
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Only treatment emergent events have been presented. They are defined as events started at or after the 1st administration of study medication and include events started prior to the 1st administration but which worsened after the 1st intake.
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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