Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis
This study has been completed.
Sponsor:
Abbott Products
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
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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:
Genetics Home Reference related topics:
hereditary pancreatitis
MedlinePlus related topics:
Pancreatitis
U.S. FDA Resources
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
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# 45382 | |
| Pune, India, 411 004 | |
| Site Reference ID/Investigator# 45395 | |
| Pune, India, 411013 | |
| 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 Pancreatic Diseases Digestive System Diseases |
Pancreatin Pancrelipase Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013