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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

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ClinicalTrials.gov Identifier: NCT00414908
Recruitment Status : Completed
First Posted : December 22, 2006
Results First Posted : September 16, 2009
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:
Solvay Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE December 21, 2006
First Posted Date  ICMJE December 22, 2006
Results First Submitted Date  ICMJE August 7, 2009
Results First Posted Date  ICMJE September 16, 2009
Last Update Posted Date August 10, 2011
Study Start Date  ICMJE October 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2011)
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) ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2006)
Change in CFA from baseline
Change History Complete list of historical versions of study NCT00414908 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2011)
  • 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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    4- point ordinal scale on this symptom from 0 (None) to 3 (Severe).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2006)
Change in CNA from baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Pancreatitis
  • Pancreatectomy
  • Pancreatic Exocrine Insufficiency
Intervention  ICMJE
  • Drug: Pancrelipase delayed release capsule
    24,000 unit capsule
  • Drug: Placebo Comparator
    Placebo
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Pancrelipase delayed release capsule
  • Placebo Comparator: B
    Intervention: Drug: Placebo Comparator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2007)
52
Original Enrollment  ICMJE
 (submitted: December 21, 2006)
112
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Poland,   Puerto Rico,   Russian Federation,   Serbia,   South Africa,   Ukraine,   United States
Removed Location Countries Former Serbia and Montenegro
 
Administrative Information
NCT Number  ICMJE NCT00414908
Other Study ID Numbers  ICMJE S245.3.124
2004-000227-15 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gregor Eibes, Solvay Pharmaceuticals
Study Sponsor  ICMJE Solvay Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
PRS Account Solvay Pharmaceuticals
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP