Status:
COMPLETED
A Pilot Study of Hemin Therapy for Gastroparesis (Diabetes Mellitus)
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
RECORDATI GROUP
Conditions:
Gastroparesis
Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 (gastropare...
Detailed Description
Therapeutic options for management of diabetic gastroparesis are limited. Failure to maintain upregulation of heme oxygenase 1 (HO1) leads to loss of interstitial cells of Cajal and delayed gastric em...
Eligibility Criteria
Inclusion
- Where relevant (i.e., for ensuring safety), the inclusion and exclusion criteria are similar to those in a recently completed trial of hemin therapy for myelodysplastic syndrome at Rush University, Chicago (http://clinicaltrials.gov/ct2/show/NCT00467610).
- Upper gastrointestinal symptoms which satisfy criteria for postprandial distress syndrome or vomiting for the last 3 months with symptom onset at least 6 months prior to diagnosis
- At least moderately severe symptoms as manifest by a total symptom score of 2.5 or higher on the Gastroparesis Cardinal Symptom Index (GCSI)21
- Delayed gastric emptying (i.e, \< 40% emptying at 2 and/or \< 90% emptying at 4 hours by scintigraphy)
- No structural cause for symptoms by endoscopy within the past 12 months
- Patient must have a platelet counts \> 50,000/microliters and absolute neutrophil counts (ANC) \>500/microliters.
- Patient must have adequate hepatic and renal functions, defined as serum bilirubin, serum glutamic-oxaloacetic transaminase (SGOT), and serum glutamate pyruvate transaminase (SGPT) ≤ 2 times the upper limit of normal (ULN), and creatinine ≤ 1.5 times the ULN.
- Able to provide written informed consent before participating in the study
- If female:
- Either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if of childbearing potential, must comply with an effective method of birth control acceptable to the investigator during the study (oral contraceptives, Depo-Provera, intra-uterine device or barrier methods)
- Patient is not breastfeeding.
- Patient of childbearing potential must have a negative urine or serum pregnancy test during the screening period.
Exclusion
- History of allergic reaction or significant sensitivity to Panhemantin ®
- Patients who have taken or used any investigational drug or device in the 30 days prior to screening
- Predominant symptoms of epigastric pain or rumination syndrome
- Structural cause for symptoms on recent endoscopy
- Patients with preexisting blood coagulation abnormalities
- Patients with previously documented renal impairment defined as above 150 mmol/L or 1.7 mg/dL serum creatinine
- Previous gastric or intestinal surgery - patients with enteral feeding tubes and/or venting/feeding gastrostomy will be eligible provided they can comply with study requirements. Tube feeding will be stopped 24 hours before the gastric emptying study
- Current use of narcotics, anticholinergic agents (e.g., hyoscyamine, belladonna), anticoagulants (e.g., warfarin) or erythromycin. Gastrointestinal prokinetic drugs (eg metoclopramide, or domperidone) may be continued at a stable dose throughout the study
- History of a pre-existing medical condition that, in the opinion of the investigator, will interfere with the participation in the study.
- History of venous thrombosis or hypercoagulable state
- Poor peripheral venous access, if central venous access is not available
- Uncontrolled active infection
- Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study.
- Known intolerance or allergy to eggs
- Screening weight greater than 130 kg
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01206582
Start Date
May 1 2010
End Date
December 1 2014
Last Update
February 4 2016
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55901