Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00095732 |
Recruitment Status :
Completed
First Posted : November 9, 2004
Last Update Posted : October 17, 2014
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Condition or disease | Intervention/treatment | Phase |
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Cystic Fibrosis Pancreatic Insufficiency | Drug: Liprotamase Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 129 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized, Double Blind, Parallel Dose Ranging Study of Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency |
Study Start Date : | June 2004 |
Actual Primary Completion Date : | March 2005 |
Actual Study Completion Date : | March 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: Low Liprotamase Dose
Liprotamase in a fixed combination of lipase (5,000 units), protease (5,000 units) and amylase (750 units) administered orally (one Size 5 capsule of liprotamase and five Size 2 capsules of placebo) with each of three meals and two snacks daily for 28 days
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Drug: Liprotamase
Administered orally as either Size 2 capsules (20,000 Units lipase; 20,000 Units protease; and 3,000 Units amylase) or Size 5 capsules (5,000 Units lipase; 5,000 Units protease; and 750 Units amylase)
Other Names:
Drug: Placebo Administered orally in either Size 2 or Size 5 capsules |
Experimental: Mid Liprotamase Dose
Liprotamase in a fixed combination of lipase (25,000 units), protease (25,000 units) and amylase (3,750 units) administered orally (one Size 5 capsule of liprotamase, one Size 2 capsule of liprotamase, and four Size 2 capsules of placebo) with each of three meals and two snacks daily for 28 days
|
Drug: Liprotamase
Administered orally as either Size 2 capsules (20,000 Units lipase; 20,000 Units protease; and 3,000 Units amylase) or Size 5 capsules (5,000 Units lipase; 5,000 Units protease; and 750 Units amylase)
Other Names:
Drug: Placebo Administered orally in either Size 2 or Size 5 capsules |
Experimental: High Liprotamase Dose
Liprotamase in a fixed combination of lipase (100,000 units), protease (100,000 units) and amylase (15,000 units) administered orally (one Size 5 capsule of placebo and five Size 2 capsules of liprotamase) with each of three meals and two snacks daily for 28 days
|
Drug: Liprotamase
Administered orally as either Size 2 capsules (20,000 Units lipase; 20,000 Units protease; and 3,000 Units amylase) or Size 5 capsules (5,000 Units lipase; 5,000 Units protease; and 750 Units amylase)
Other Names:
Drug: Placebo Administered orally in either Size 2 or Size 5 capsules |
- Change from baseline up to 19 days in Coefficient of fat absorption (CFA) [ Time Frame: Baseline, up to 19 days ]
- Change from baseline up to 19 day in Coefficient of nitrogen absorption (CNA) [ Time Frame: Baseline, up to 19 days ]
- Change from baseline up to 19 days in stool weight [ Time Frame: Baseline, up to 19 days ]
- Change from baseline to 29 day endpoint in Cystic Fibrosis Questionnaire (CFQ) scale scores [ Time Frame: Baseline, 29 days ]
- Change from baseline up to 19 days in number of Stools [ Time Frame: Baseline, up to 19 days ]
- Change from baseline to 28 days in maximum change in glucose response [ Time Frame: Baseline through 28 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 7 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pancreatic insufficiency (PI) documented by fecal elastase <100 mcg/gram measured at screening
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Diagnosis of CF based upon the following criteria:
- two clinical features consistent with CF AND
- either genotype with two identifiable mutations consistent with CF OR
- sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis
- Forced Expiratory Volume Over One Second (FEV1) ≥30% predicted
- Clinically stable with no evidence of acute upper or lower respiratory tract infection
Exclusion Criteria:
- Pregnancy, breastfeeding or of childbearing potential and/or not willing to use accepted methods of birth control during enrollment in the study
- History of fibrosing colonopathy
- History of liver transplant or lung transplant
- Unable to discontinue enteral tube feedings during the study
- Subject weight <40 kg
- Known hypersensitivity to food additives
- Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
- Unable to discontinue the use of pancreatic enzymes for a 72-hour period or any other condition that the investigator believes would interfere with the intent of this study or would make study participation not in the best interest of the subject

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095732
United States, Alabama | |
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. | |
Birmingham, Alabama, United States, 35233 | |
United States, California | |
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. | |
Palo Alto, California, United States, 94304 | |
United States, Colorado | |
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. | |
Denver, Colorado, United States, 80218 | |
United States, Florida | |
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. | |
Gainesville, Florida, United States, 32610 | |
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Jacksonville, Florida, United States, 32207 | |
United States, Illinois | |
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Chicago, Illinois, United States, 60614 | |
United States, Indiana | |
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Indianapolis, Indiana, United States, 46202 | |
United States, Iowa | |
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. | |
Iowa City, Iowa, United States, 52242 | |
United States, Kentucky | |
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. | |
Lexington, Kentucky, United States, 40536 | |
United States, Louisiana | |
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. | |
New Orleans, Louisiana, United States, 70112 | |
United States, Maryland | |
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Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
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, 02114 | |
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Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
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Ann Arbor, Michigan, United States, 48109 | |
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Grand Rapids, Michigan, United States, 49503 | |
United States, Minnesota | |
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Minneapolis, Minnesota, United States, 55455 | |
United States, Mississippi | |
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Jackson, Mississippi, United States, 39216 | |
United States, Missouri | |
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St. Louis, Missouri, United States, 63110 | |
United States, New York | |
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Buffalo, New York, United States, 14215 | |
United States, Ohio | |
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Cincinnati, Ohio, United States, 45267 | |
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Cleveland, Ohio, United States, 44106 | |
United States, Oregon | |
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. | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
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. | |
Pittsburgh, Pennsylvania, United States, 15212 | |
United States, Texas | |
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. | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
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. | |
Salt Lake City, Utah, United States, 84132 | |
United States, Vermont | |
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. | |
Burlington, Vermont, United States, 05401 | |
United States, West Virginia | |
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. | |
Morgantown, West Virginia, United States, 26506 |
Responsible Party: | Anthera Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00095732 |
Other Study ID Numbers: |
14269 I5L-MC-TCAA ( Other Identifier: Eli Lilly and Company ) TC-2A ( Other Identifier: Altus/Alnara ) |
First Posted: | November 9, 2004 Key Record Dates |
Last Update Posted: | October 17, 2014 |
Last Verified: | October 2014 |
Pancreatic Insufficiency Cystic Fibrosis Enzymes |
Cystic Fibrosis Exocrine Pancreatic Insufficiency Fibrosis Pathologic Processes Pancreatic Diseases |
Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |