A Pilot Study of Hemin Therapy for Gastroparesis (Diabetes Mellitus)
Condition: Gastroparesis; Diabetes Mellitus
MeSH terms: Gastroparesis; Diabetes Mellitus
Intervention: Hemin; Albumin
Intervention description: 10 iv infusions for 8 weeks; 10 iv infusions for 8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        Inclusion Criteria:

        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 Criteria:

          -  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