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Completed

NCT Number: NCT00414908

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 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.

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Digestive System Diseases Disease Attributes Exocrine Pancreatic Insufficiency Pancreatectomy Pancreatic Diseases Pancreatic Exocrine Insufficiency Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 23, Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pancrelipase delayed release capsule

Drug

24,000 unit capsule

placebo comparator

Drug

Placebo

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

Other outcomes

  1. Change of Stool Frequency Between "Original" Baseline and End of Open-label Period (OL)

    Time frame: 27 weeks

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

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Dec 22, 2006
Registry last updated
Aug 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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