A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency

This study has been completed.

Study NCT00662675 Information provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

First Received on April 17, 2008. Last Updated on May 17, 2011 History of Changes

Results First Received: February 5, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Exocrine Pancreatic Insufficiency Steatorrhea Malabsorption Syndromes Cystic Fibrosis
Interventions:	Drug: Pancrease MT 10.5, or MT 21 Drug: Placebo for Pancrease MT 10.5 or MT 21

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The initial (screening) dose of PANCREASE MT was based on the average dose of pancreatic enzyme replacement therapy (PERT) taken for the 3 days immediately before entry into the study in combination with a high-fat diet. This PERT was continued until all screening test results were received and the subject met all inclusion/exclusion criteria.

Reporting Groups

	Description
Placebo	Matching placebo capsules taken by mouth per meal or snack
PANCREASE MT	Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack

Participant Flow: Overall Study

	Placebo	PANCREASE MT
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Matching placebo capsules taken by mouth per meal or snack
PANCREASE MT	Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack

Baseline Measures

	Placebo	PANCREASE MT	Total
Number of Participants [units: participants]	20	20	40
Age [units: years] Mean ± Standard Deviation	23.4 ± 11.58	24 ± 13.44	23.7 ± 12.39
Gender [units: participants]
Female	7	11	18
Male	13	9	22
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	1	1	2
White	19	17	36
More than one race	0	0	0
Unknown or Not Reported	0	1	1

Outcome Measures

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1. Primary:

Change in the Coefficient of Fat Absorption (COA-fat Percent) [ Time Frame: 72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase. ]

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2. Secondary:

Change in Percent COA-Protein (Nitrogen) [ Time Frame: 72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase. ]

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3. Secondary:

Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase [ Time Frame: Entire 7 days double-blind phase ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Director, Clinical Team Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development, LLC
phone: 609-730-3158

No publications provided

Responsible Party:	Senior Director, Compound Development Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00662675 History of Changes
Other Study ID Numbers:	CR014719
Study First Received:	April 17, 2008
Results First Received:	February 5, 2010
Last Updated:	May 17, 2011
Health Authority:	United States: Food and Drug Administration