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A Pilot Study of Hemin Therapy for Gastroparesis (Diabetes Mellitus)

NCT01206582 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-02-04

Study results available
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Summary

This study is designed to learn if hemin can increase the production of heme oxygenase 1 and improve gastric (stomach) emptying and symptoms in diabetic patients with slow gastric emptying (gastroparesis).

Conditions

Interventions

BIOLOGICAL

Hemin

10 iv infusions for 8 weeks

BIOLOGICAL

Albumin

10 iv infusions for 8 weeks

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Recordati Rare Diseases

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Adil E Bharucha, MBBS, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01206582 on ClinicalTrials.gov