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

This study is ongoing, but not recruiting participants.

First Received: June 26, 2008 Last Updated: April 28, 2009 History of Changes

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00705978

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 III

Drug Information available for: Pancreatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Solvay Pharmaceuticals:

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:	July 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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)
2: Placebo Comparator	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705978

Locations

India
Site 01
New Delhi, India
Site 02
Mumbai, India
Site 03
Kolkatta, India
Site 04
Kochin, India
Site 05
Jaipur, India
Site 06
Bangalore, India
Site 13
Bhopal, India
Site 08
Hyderabaad, India
Site 09
Pune, India
Site 11
Pune, India
Site 12
Trivandrum, India
Site 07
Chennai, India

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Gregor Eibes )
Study ID Numbers:	S245.4.009
Study First Received:	June 26, 2008
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00705978 History of Changes
Health Authority:	India: Ministry of Health

Keywords provided by Solvay Pharmaceuticals:

Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

Study placed in the following topic categories:

Digestive System Diseases
Pancreatic Diseases
Pancrelipase
Pancreatitis

Exocrine Pancreatic Insufficiency
Pancreatin
Pancreatitis, Chronic

Additional relevant MeSH terms:

Digestive System Diseases
Therapeutic Uses
Gastrointestinal Agents
Pancreatic Diseases
Pharmacologic Actions

Pancreatitis
Exocrine Pancreatic Insufficiency
Pancreatin
Pancreatitis, Chronic

ClinicalTrials.gov processed this record on May 06, 2009