Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
39 participants
INTERVENTIONAL
2007-12-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Liprotamase
Liprotamase is a fixed combination of lipase (32,500 units), protease (25,000 units) and amylase (3,750 units) administered orally with each of three meals and two snacks daily for 12 months
Liprotamase
Administered orally
Interventions
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Liprotamase
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fecal elastase levels \< 100 micrograms per gram (µg/g) stool measured at screening
* Able to perform the testing and procedures required for the study, as judged by the investigator
* Diagnosis of chronic pancreatitis or status post pancreatectomy
Diagnosis of chronic pancreatitis is based upon at least one of the following:
* Endoscopic retrograde pancreatography, magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasound demonstrating ductal changes consistent with chronic pancreatitis
* Abnormal Secretin Pancreatic Function test with a peak bicarbonate concentration \< 75 milliequivalents per liter (mEq/L)
* Presence of pathognomic pancreatic calcifications
* Pathology proven chronic pancreatitis on surgical specimens
Exclusion Criteria
* History of liver transplant
* Liver transaminases \>3x Upper Limit Normal (ULN) or total bilirubin \>1.5x ULN at screening or at Baseline (except for patients with Gilbert's Syndrome)
* Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
* Any condition that the investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient
* History of pancreatic cancer
* Diagnosis of cystic fibrosis
* Active alcohol or drug abuse
* Presence of any medical condition that is likely to preclude survival for 12 months
* Demonstrated unlikely to comply with protocol requirements or complete the study
18 Years
ALL
No
Sponsors
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Anthera Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hamden, Connecticut, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jacksonville, Florida, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chicago, Illinois, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis, Indiana, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shreveport, Louisiana, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Boston, Massachusetts, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Boston, Massachusetts, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
St Louis, Missouri, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lebanon, New Hampshire, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mineola, New York, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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I5L-MC-TCAD
Identifier Type: OTHER
Identifier Source: secondary_id
810
Identifier Type: OTHER
Identifier Source: secondary_id
14294
Identifier Type: -
Identifier Source: org_study_id
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