A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Aptalis Pharma.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Eurand Pharmaceuticals
Collaborator:
University of Florida
Information provided by:
Aptalis Pharma
ClinicalTrials.gov Identifier:
NCT01159119
First received: July 5, 2010
Last updated: July 7, 2010
Last verified: July 2010
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Purpose
The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Pancreatitis |
Drug: EUR-1066-A Drug: Zenpep Drug: EUR-1066-B |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Single Center Randomized Single Blind Crossover Group Active Control Study to Evaluate Safety and Efficacy of EUR-1066 a Pancreatic Enzyme Product in Patients With Chronic Pancreatitis Exocrine Pancratic Insufficiency,Chronic Abdominal Pain |
Resource links provided by NLM:
Further study details as provided by Aptalis Pharma:
Primary Outcome Measures:
- Comparing frequency and severity of pain [ Time Frame: up to 84 days ] [ Designated as safety issue: Yes ]Patient diary
Secondary Outcome Measures:
- Changes in fat malabsorption [ Time Frame: up to 124 days ] [ Designated as safety issue: Yes ]Assess the coefficient of fat absorption
| Estimated Enrollment: | 15 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EUR-1066-A
Treatment with Eur-1006-A.
|
Drug: EUR-1066-A
Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.
Other Name: EUR-1066
|
|
Experimental: EUR-1066-B
Treatment with Eur-1066-B
|
Drug: EUR-1066-B
Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.
Other Name: EUR-1066
|
|
Active Comparator: Zenpep
Control Group: Consist of treatment with Zenpep
|
Drug: Zenpep
Capsules taken for daily for 28 days during treatment period 2
Other Name: ZENPEP
|
Detailed Description:
To evaluate two different preparations of a pancreatic enzyme in subjects with chronic pancreatitis, exocrine pancreatic insufficiency, and chronic abdominal pain.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of Chronic Pancreatitis
- Exocrine Pancreatic Insufficiency
- Chronic abdominal pain
Exclusion Criteria:
- Acute pancreatitis
- Active alcohol consumption
- Uncontrolled diabetes
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159119
Locations
| United States, Florida | |
| University of Florida | Not yet recruiting |
| Gainesville, Florida, United States, 32611 | |
| Contact: Cheryl Curington 352-392-6293 cheryl.curington@medicine.ufl.edu | |
| Principal Investigator: Phillip Toskes, MD | |
Sponsors and Collaborators
Eurand Pharmaceuticals
University of Florida
Investigators
| Principal Investigator: | Phillip Toskes, MD | University of Florida |
More Information
No publications provided
| Responsible Party: | Angelo Secci MD, Eurand |
| ClinicalTrials.gov Identifier: | NCT01159119 History of Changes |
| Other Study ID Numbers: | PR-012 |
| Study First Received: | July 5, 2010 |
| Last Updated: | July 7, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Aptalis Pharma:
|
Chronic Abdominal Pain Exocrine Pancreatic Insufficiency |
Additional relevant MeSH terms:
|
Abdominal Pain Exocrine Pancreatic Insufficiency Pancreatitis Pancreatitis, Chronic Pain |
Signs and Symptoms Signs and Symptoms, Digestive Pancreatic Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013