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.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00414908
First received: December 21, 2006
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Chronic Pancreatitis
Pancreatectomy
Pancreatic Exocrine Insufficiency
Drug: Pancrelipase delayed release capsule
Drug: Placebo Comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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. [ Time Frame: End of double-blind period (5-7 days) ] [ Designated as safety issue: No ]
    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. [ Time Frame: End of double-blind period (5-7 days) ] [ Designated as safety issue: No ]
    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. [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
    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. [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
    4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery).

  • Flatulence at the End of Double-blind Period [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
    4- point ordinal scale on this symptom from 0 (None) to 3 (Severe).


Enrollment: 52
Study Start Date: October 2007
Study Completion Date: December 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Pancrelipase delayed release capsule
24,000 unit capsule
Placebo Comparator: B Drug: Placebo Comparator
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414908

  Show 30 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

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

Keywords provided by Solvay Pharmaceuticals:
Chronic Pancreatitis
Pancreatectomy
Pancreatic Exocrine Insufficiency

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014