Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-31 @ 4:12 PM
Study NCT ID:
NCT00782795
Status:
COMPLETED
Last Update Posted:
2018-01-11
First Post:
2008-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Phase II Study of Chronic Pancreatitis and the Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if study drug (Pioglitazone) treatment will improve pre-diabetes (insulin resistance) or ealy diabetes and improve clinical symptoms (pain) or laboratory evidence of chronic pancreatitis.
The goal of the investigators is to gather information from this study to help gain understanding of a potential therapy for chronic pancreatitis.
The goal of the investigators is to gather information from this study to help gain understanding of a potential therapy for chronic pancreatitis.
Detailed Description:
The pancreas is a digestive organ that secretes insulin (and other hormones) into the blood for regulating blood sugar (glucose) and digestive enzymes into the intestine for digesting and absorbing nutrients consumed in meals. Chronic pancreatitis is a progressive clinical disease of the pancreas, associated with swelling (inflammation), scarring (fibrosis) and loss of normal functioning tissue. Patients develop diabetes mellitus (elevated blood sugar), malabsorption of nutrients, weight loss and pain. Presently chronic pancreatitis is considered an irreversible condition because the mechanisms responsible for chronic pancreatitis are poorly understood and no therapy is proven. However, recent studies provide important clues that oral medications (Thiazolidinediones) used to treat diabetes mellitus might improve or reverse features of chronic pancreatitis, including elevated sugar or diabetes, reduced secretion of digestive enzymes, and pancreatic swelling and scarring.
Note: Takeda Pharmaceuticals North America (TPNA) provided pioglitazone and placebo pills with identically appearance until June 28, 2010, approximately the middle of the study.
Note: Takeda Pharmaceuticals North America (TPNA) provided pioglitazone and placebo pills with identically appearance until June 28, 2010, approximately the middle of the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R21AA017271 | NIH | None | https://reporter.nih.gov/quic… | View |
| 1R21AA017271-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |