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

Primary Purpose

Chronic Pancreatitis, Pancreatectomy, Pancreatic Exocrine Insufficiency

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pancrelipase delayed release capsule

Placebo Comparator

About this trial

This is an interventional treatment trial for Chronic Pancreatitis focused on measuring Chronic Pancreatitis, Pancreatectomy, Pancreatic Exocrine Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria:

Direct or indirect pancreatic function test (except stool fat excretion) or Clinical signs of severe steatorrhoea that resolved upon administration of pancreatic supplementation.
Total stool fat > 40 g over 4 days (using Van De Kamer method)
Proven chronic pancreatitis
Females of child-bearing potential must agree to continue using a medically acceptable method of birth control

Exclusion Criteria:

Ileus or acute abdomen
Any type of malignancy involving the digestive tract in the last 5 years
Presence of pseudo-pancreatic cyst ≥ 4
Continued excessive intake of alcohol or drug abuse
Known infection with HIV

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.

The CFA is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Higher values indicated a better response. Change is calculated as (DB CFA-Baseline CFA).

Secondary Outcome Measures

Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.

The CNA is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Higher values indicated a better response. Change is calculated as (DB CNA-Baseline CNA).

Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.

Total amount of fat excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool fat - Baseline stool fat).

Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.

Total amount of nitrogen excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool nitrogen - Baseline stool nitrogen).

Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period

Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response. Change was calculated as (DB stool frequency - Baseline Stool frequency).

Abdominal Pain at the End of the Double-blind Period.

4- point ordinal scale on this symptom from 0 (No Abdominal pain) to 3 (Severe abdominal pain).

Stool Consistency at the End of the Double-blind Period

4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery).

Flatulence at the End of Double-blind Period

4- point ordinal scale on this symptom from 0 (None) to 3 (Severe).

Full Information

NCT ID

NCT00414908

First Posted

December 21, 2006

Last Updated

August 8, 2011

Sponsor

Solvay Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00414908

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Solvay Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-Label Follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pancreatitis, Pancreatectomy, Pancreatic Exocrine Insufficiency

Keywords

Chronic Pancreatitis, Pancreatectomy, Pancreatic Exocrine Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Pancrelipase delayed release capsule

Intervention Description

24,000 unit capsule

Intervention Type

Drug

Intervention Name(s)

Placebo Comparator

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.

Description

The CFA is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Higher values indicated a better response. Change is calculated as (DB CFA-Baseline CFA).

Time Frame

End of double-blind period (5-7 days)

Secondary Outcome Measure Information:

Title

Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.

Description

Time Frame

End of double-blind period (5-7 days)

Title

Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.

Description

Total amount of fat excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool fat - Baseline stool fat).

Time Frame

End of double-blind period (5-7 days)

Title

Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.

Description

Total amount of nitrogen excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool nitrogen - Baseline stool nitrogen).

Time Frame