Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

This study has been completed.

Study NCT00510484 Information provided by Solvay Pharmaceuticals

First Received on August 1, 2007. Last Updated on May 26, 2010 History of Changes

Results First Received: May 29, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Cystic Fibrosis
Interventions:	Drug: Pancrelipase Delayed Release Drug: Placebo Comparator

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
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Placebo/Pancrelipase	No text entered.
Pancrelipase/Placebo	No text entered.

Participant Flow for 3 periods

Period 1: Period 1

	Placebo/Pancrelipase	Pancrelipase/Placebo
STARTED	16	16
COMPLETED	16	16
NOT COMPLETED	0	0

Period 2: Wash-out Period

	Placebo/Pancrelipase	Pancrelipase/Placebo
STARTED	16	16
COMPLETED	16	15
NOT COMPLETED	0	1
Adverse Event	0	1

Period 3: Period 2

	Placebo/Pancrelipase	Pancrelipase/Placebo
STARTED	16	15
COMPLETED	16	15
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo/Pancrelipase	No text entered.
Pancrelipase/Placebo	No text entered.

Baseline Measures

	Placebo/Pancrelipase	Pancrelipase/Placebo	Total
Number of Participants [units: participants]	16	16	32
Age [units: years] Mean ± Standard Deviation	22.2 ± 7.8	22.8 ± 6.5	22.5 ± 7.1
Gender [units: participants]
Female	4	7	11
Male	12	9	21
Region of Enrollment [units: participants]
United States	16	16	32

Outcome Measures

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1. Primary:

Coefficient of Fat Absorption (%) [ Time Frame: 5 days ]

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2. Secondary:

Coefficient of Nitrogen Absorption (%) [ Time Frame: 5 days ]

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3. Secondary:

Total Fat Excretion (Grams) [ Time Frame: 5 days ]

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4. Secondary:

Total Stool Weight (Grams) [ Time Frame: 5 days ]

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5. Secondary:

Stool Frequency [ Time Frame: 5 days ]

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6. Secondary:

Percentage of Days With no Flatulence. [ Time Frame: 5 days ]

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7. Secondary:

Percentage of Days With no Abdominal Pain. [ Time Frame: 5 days ]

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8. Other Pre-specified:

Percentage of Days With Formed/Normal Stools. [ Time Frame: 5 days ]

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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. Restriction Description: 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.

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
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.

Results Point of Contact:

Name/Title: Sven Voet - Global Communication
Organization: Solvay Pharmaceuticals
phone: +32 (0)2 509 69 77
e-mail: sven.voet@solvay.com

Publications of Results:

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. Epub 2009 Oct 7.

Responsible Party:	Djenane Bennett, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00510484 History of Changes
Other Study ID Numbers:	S245.3.126, 2007-004005-10
Study First Received:	August 1, 2007
Results First Received:	May 29, 2009
Last Updated:	May 26, 2010
Health Authority:	United States: Institutional Review Board