A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy

This study has been completed.

Study NCT00414908 Information provided by Solvay Pharmaceuticals

First Received on December 21, 2006. Last Updated on August 8, 2011 History of Changes

Results First Received: August 7, 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
Conditions:	Chronic Pancreatitis Pancreatectomy Pancreatic Exocrine Insufficiency
Interventions:	Drug: Pancrelipase delayed release capsule 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 centers in Bulgaria, Poland, Russia, Serbia, Ukraine and US between April 2007 and August 2008. This report presents the double-blind (DB) period of the study as well as the Open Label (OL) results.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was a run-in with a 5-day of single-blind placebo treatment. One hundred and eighty subjects were consented and 179 entered the run-in. A total of 54 subjects were randomly allocated to treatment. Only two subjects did not complete the DB period of the treatment because of protocol violation. Fifty one patients entered the OL period.

Reporting Groups

	Description
Pancrelipase (DB)	Pancrelipase delayed release capsules given during the Double-Blind period
Placebo (DB)	Placebo group given during the Double-Blind period

Participant Flow: Overall Study

	Pancrelipase (DB)	Placebo (DB)
STARTED	25	29
COMPLETED	24	28
NOT COMPLETED	1	1
Protocol Violation	1	1

Baseline Characteristics

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Reporting Groups

	Description
Pancrelipase (DB)	Pancrelipase delayed release capsules given during the Double-Blind period
Placebo (DB)	Placebo group given during the Double-Blind period

Baseline Measures

	Pancrelipase (DB)	Placebo (DB)	Total
Number of Participants [units: participants]	24	28	52
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	23	27	50
>=65 years	1	1	2
Age [units: years] Mean ± Standard Deviation	51.7 ± 9.7	50.4 ± 7.8	51.0 ± 8.7
Gender [units: participants]
Female	6	9	15
Male	18	19	37
Region of Enrollment [units: participants]
Serbia	1	3	4
United States	6	6	12
Poland	7	7	14
Ukraine	3	4	7
Russian Federation	2	2	4
Bulgaria	5	6	11

Outcome Measures

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1. Primary:

Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period. [ Time Frame: End of double-blind period (5-7 days) ]

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2. Secondary:

Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period. [ Time Frame: End of double-blind period (5-7 days) ]

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3. Secondary:

Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period. [ Time Frame: End of double-blind period (5-7 days) ]

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4. Secondary:

Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period. [ Time Frame: End of double-period (5-7 days) ]

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5. Secondary:

Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period [ Time Frame: End of double-period (5-7 days) ]

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6. Secondary:

Abdominal Pain at the End of the Double-blind Period. [ Time Frame: End of double-period (5-7 days) ]

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7. Secondary:

Stool Consistency at the End of the Double-blind Period [ Time Frame: End of double-period (5-7 days) ]

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8. Secondary:

Flatulence at the End of Double-blind Period [ Time Frame: End of double-period (5-7 days) ]

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9. Other Pre-specified:

Change of Stool Frequency Between "Original" Baseline and End of Open-label Period (OL) [ Time Frame: 27 weeks ]

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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 includes 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: Abbott Products
phone: +41 61 487 08 56
e-mail: sven.voet@abbott.com

No publications provided

Responsible Party:	Gregor Eibes, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00414908 History of Changes
Other Study ID Numbers:	S245.3.124, 2004-000227-15
Study First Received:	December 21, 2006
Results First Received:	August 7, 2009
Last Updated:	August 8, 2011
Health Authority:	United States: Food and Drug Administration