Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis

This study has been completed.
Sponsor:
Collaborator:
Quintiles, Datamap
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00705978
First received: June 26, 2008
Last updated: August 16, 2011
Last verified: August 2011
  Purpose

This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be assessed and correlated with CFA.


Condition Intervention Phase
Pancreatic Insufficiency
Drug: Pancreatin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A One Week Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study With Creon 40,000 MMS in Subjects With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Followed by an Open-Label Long-Term Extension

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Change in CFA from baseline to the end of double blind treatment [ Time Frame: 7 days after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CNA, stool fat, stool weight, nutritional, clinical symptomatology, SF-36, BMI [ Time Frame: 7 days after baseline, and end of open-label period (1 year of open label treatment) ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: June 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Pancreatin
Pancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks)
Placebo Comparator: 2 Drug: Placebo
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 a pancreatic function test
  • Chronic pancreatitis has to be proven (in medical history) by CT, ERCP, plain film with pancreatic calcifications, ultrasonography (calcifications,duct dilatation) and /or histology
  • Females must be non-lactating and either be of non-childbearing potential or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to Visit 1 (Day -14).
  • Subjects with a pathological stool fat during run in period (> 10g/24 h)

Exclusion Criteria

  • Ileus or acute abdomen
  • Any type of malignancy involving the digestive tract in the last 5 years
  • Presence of pseudo pancreatic cysts >= 4 cm
  • Current excessive intake of alcohol or drug abuse
  • Hypersensitivity vs porcine proteins / pancreatin
  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: NCT00705978

Locations
India
Site Reference ID/Investigator# 45389
Bangalore, India, 560017
Site Reference ID/Investigator# 45396
Bhopal, India, 462 016
Site Reference ID/Investigator# 45390
Chennai, India, 600096
Site Reference ID/Investigator# 54382
Cochin, India, 682304
Site Reference ID/Investigator# 45391
Hyderabad, India, 500082
Site Reference ID/Investigator# 45388
Jaipur, India, 302001
Site Reference ID/Investigator# 45387
Kolkatta, India, 700054
Site Reference ID/Investigator# 45383
Mumbai, India, 400012
Site Reference ID/Investigator# 45395
Pune, India, 411013
Site Reference ID/Investigator# 45382
Pune, India, 411 004
Site Reference ID/Investigator# 45393
Trivandrum, India, 695607
Sponsors and Collaborators
Abbott Products
Quintiles, Datamap
Investigators
Study Director: Guenter Krause, MD Abbott Products
  More Information

No publications provided

Responsible Party: Gregor Eibes, Clinical Trial Manager, Abbott Products
ClinicalTrials.gov Identifier: NCT00705978     History of Changes
Other Study ID Numbers: S245.4.009
Study First Received: June 26, 2008
Last Updated: August 16, 2011
Health Authority: India: Ministry of Health

Keywords provided by Abbott:
Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

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

ClinicalTrials.gov processed this record on October 20, 2014