Creon After Pancreatic Surgery
This study has been completed.
Sponsor:
Abbott Products
Collaborators:
Quintiles
Data Map GmbH
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00535756
First received: September 25, 2007
Last updated: August 16, 2011
Last verified: August 2011
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Purpose
This study will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term safety data. During the long-term treatment with Creon 25000 nutritional parameters will be assessed and correlated with CFA
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Insufficiency |
Drug: Creon Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | One Week Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center Study With Creon® 25000 Minimicrospheres™ in Subjects With Pancreatic Exocrine Insufficiency After Pancreatic Surgery, Followed by an Open-Label Long-Term Extension of 1 Year |
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 parameters, 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: | 58 |
| Study Start Date: | April 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Creon
3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules 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 the following criteria:
- Direct or indirect pancreatic function test (except stool fat excretion) and
- Steatorrhoea: stool fat > 15 g/day (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
- Subjects in an unstable situation (catabolic) after pancreatic surgery
- Ileus or acute abdomen
- Current excessive intake of alcohol or drug abuse
- Hypersensitivity vs porcine proteins / pancreatin
- Subjects taking digestive enzyme preparations have to stop them before start of the run-in period
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535756
Locations
| Bulgaria | |
| Site Reference ID/Investigator# 45022 | |
| Ruse, Bulgaria, 7002 | |
| Site Reference ID/Investigator# 45020 | |
| Sofia, Bulgaria, 1233 | |
| Germany | |
| Site Reference ID/Investigator# 45026 | |
| Greifswald, Germany, MV 17475 | |
| Site Reference ID/Investigator# 45025 | |
| Hamburg, Germany, 20246 | |
| Site Reference ID/Investigator# 45027 | |
| Heidelberg, Germany, 69120 | |
| Site Reference ID/Investigator# 45024 | |
| Munich, Germany, 81675 | |
| Hungary | |
| Site Reference ID/Investigator# 45126 | |
| Bekescsaba, Hungary, 5600 | |
| Site Reference ID/Investigator# 45121 | |
| Budaors, Hungary, 2040 | |
| Site Reference ID/Investigator# 45127 | |
| Dunaujvaros, Hungary, 2400 | |
| Site Reference ID/Investigator# 45115 | |
| Gyula, Hungary, 5700 | |
| Site Reference ID/Investigator# 45116 | |
| Sopron, Hungary, 9400 | |
| Site Reference ID/Investigator# 45114 | |
| Szeged, Hungary, 6720 | |
| Italy | |
| Site Reference ID/Investigator# 45130 | |
| Bologna, Italy, 40138 | |
| Site Reference ID/Investigator# 45129 | |
| Padova, Italy, 35128 | |
| Site Reference ID/Investigator# 45128 | |
| Verona, Italy, 37126 | |
Sponsors and Collaborators
Abbott Products
Quintiles
Data Map GmbH
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: | NCT00535756 History of Changes |
| Other Study ID Numbers: | S245.4.008, 2005-004854-29 |
| Study First Received: | September 25, 2007 |
| Last Updated: | August 16, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Abbott:
|
Pancreatic Exocrine Insufficiency After Pancreatic Surgery |
Additional relevant MeSH terms:
|
Exocrine Pancreatic Insufficiency Pancreatic Diseases Digestive System Diseases Pancreatin |
Pancrelipase Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013