Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Pancreatitis Insulin Resistance Normal or Mildly Abnormal Stool Fat Levels

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pioglitazone

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Group Type ACTIVE_COMPARATOR

Pioglitazone

Intervention Type DRUG

Participants randomized to pioglitazone receive 30 mg taken once daily for 48 weeks.

sugar pill (placebo)

1 sugar pill (placebo) taken once daily for 48 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Pioglitazone

Participants randomized to pioglitazone receive 30 mg taken once daily for 48 weeks.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Actos

Eligibility Criteria

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Inclusion Criteria

* Insulin resistance or mild diabetes mellitus
* Symptoms of abdominal pain
* Xray test showing damage to the pancreas
* Normal or mildly abnormal stool fat levels

Exclusion Criteria

* Mentally disabled patients
* Women who are planning pregnancy, pregnant or lactating/nursing
* Chronic pancreatitis is due to other specific conditions

* Autosomal dominant pancreatitis
* Classic cystic fibrosis with lung involvement
* Autoimmune pancreatitis
* Pancreatic cancer
* Biliary obstruction (non-pancreatic cause)
* Abdominal trauma
* Hypercalcemia
* Hypertriglyceridemia
* Surgical resection of the head of the pancreas
* Alcohol consumption within prior 2 months
* Specific medical conditions

* Gastric surgery
* Celiac sprue
* Crohns disease
* Heart failure
* Kidney failure
* Cirrhosis or liver disease
* Osteoporosis
* Blood clotting disorder
* Visual problems
* Low albumin
* Low BMI
* Specific medications \*Diabetes drug treatment is allowed except for short-acting insulin, long-acting insule more than 15 units daily, pioglitazone, rosiglitazone, orlistat, acarbose, miglitol or voglibose.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes