Brief Summary

The purpose of this study is to determine the most effective dose of a new enzyme therapy on oral nutrient absorption in cystic fibrosis (CF) subjects with exocrine pancreatic insufficiency.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

129

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jun 2004

Shorter than P25 for phase_2

Geographic Reach

1 country

27 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 months study duration

Study Start

First participant enrolled

June 1, 2004

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2004

Completed

Same day until next milestone

First Posted

Study publicly available on registry

November 9, 2004

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed

Last Updated

October 17, 2014

Status Verified

October 1, 2014

Enrollment Period

9 months

First QC Date

November 9, 2004

Last Update Submit

October 15, 2014

Conditions

Cystic Fibrosis Pancreatic Insufficiency

Keywords

Pancreatic InsufficiencyCystic FibrosisEnzymes

Outcome Measures

Primary Outcomes (1)

Change from baseline up to 19 days in Coefficient of fat absorption (CFA)
Baseline, up to 19 days

Secondary Outcomes (5)

Change from baseline up to 19 day in Coefficient of nitrogen absorption (CNA)
Baseline, up to 19 days
Change from baseline up to 19 days in stool weight
Baseline, up to 19 days
Change from baseline to 29 day endpoint in Cystic Fibrosis Questionnaire (CFQ) scale scores
Baseline, 29 days
Change from baseline up to 19 days in number of Stools
Baseline, up to 19 days
Change from baseline to 28 days in maximum change in glucose response
Baseline through 28 days

Study Arms (3)

Low Liprotamase Dose

EXPERIMENTAL

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

Drug: LiprotamaseDrug: Placebo

Mid Liprotamase Dose

EXPERIMENTAL

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: LiprotamaseDrug: Placebo

High Liprotamase Dose

EXPERIMENTAL

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: LiprotamaseDrug: Placebo

Interventions

LiprotamaseDRUG

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)

Also known as: ALTU-135, LY3031642, TheraCLEC - Total

High Liprotamase DoseLow Liprotamase DoseMid Liprotamase Dose

PlaceboDRUG

Administered orally in either Size 2 or Size 5 capsules

High Liprotamase DoseLow Liprotamase DoseMid Liprotamase Dose

Eligibility Criteria

Age7 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Pancreatic insufficiency (PI) documented by fecal elastase \<100 mcg/gram measured at screening
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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Anthera Pharmaceuticalslead
Cystic Fibrosis Foundationcollaborator

Study Sites (27)

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, 35233, United States

Location

Palo Alto, California, 94304, United States

Location

Denver, Colorado, 80218, United States

Location

Gainesville, Florida, 32610, United States

Location

Jacksonville, Florida, 32207, United States

Location

Chicago, Illinois, 60614, United States

Location

Indianapolis, Indiana, 46202, United States

Location

Iowa City, Iowa, 52242, United States

Location

Lexington, Kentucky, 40536, United States

Location

New Orleans, Louisiana, 70112, United States

Location

Baltimore, Maryland, 21287, United States

Location

Boston, Massachusetts, 02114, United States

Location

Boston, Massachusetts, 02115, United States

Location

Ann Arbor, Michigan, 48109, United States

Location

Grand Rapids, Michigan, 49503, United States

Location

Minneapolis, Minnesota, 55455, United States

Location

Jackson, Mississippi, 39216, United States

Location

St Louis, Missouri, 63110, United States

Location

Buffalo, New York, 14215, United States

Location

Cincinnati, Ohio, 45267, United States

Location

Cleveland, Ohio, 44106, United States

Location

Portland, Oregon, 97239, United States

Location

Pittsburgh, Pennsylvania, 15212, United States

Location

Houston, Texas, 77030, United States

Location

Salt Lake City, Utah, 84132, United States

Location

Burlington, Vermont, 05401, United States

Location

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Cystic FibrosisExocrine Pancreatic Insufficiency

Interventions

liprotamase lipase

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 9, 2004

First Posted

November 9, 2004

Study Start

June 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

October 17, 2014

Record last verified: 2014-10

Locations

US(27)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

Low Liprotamase Dose

Mid Liprotamase Dose

High Liprotamase Dose

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (27)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations