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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01206582
First received: September 20, 2010
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Gastroparesis
Diabetes Mellitus
Biological: Hemin
Biological: Albumin (25%)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Hemin Therapy for Gastroparesis

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • - Heme-oxygenase 1 (HO-1) protein concentration [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • - HO-1 activity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Gastric emptying by scintigraphy [ Time Frame: 8 weeks (or last completed assessment) ] [ Designated as safety issue: No ]
  • - Gastrointestinal symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HO-1 protein concentration [ Time Frame: 1, 3, 4, 7, 14, 21, 28, 35, 42, and 49 days ] [ Designated as safety issue: No ]
  • Gastric emptying [ Time Frame: days 1, 4, 7, 14, 21, 28, 35, 42, and 49 ] [ Designated as safety issue: No ]
  • Gastrointestinal symptoms [ Time Frame: days 1, 4, 7, 14, 21, 28, 35, 42, and 49. ] [ Designated as safety issue: No ]
  • Autonomic functions [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Serum chemistry [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Includes serum creatinine and transaminases

  • coagulation parameters [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Includes PT and APTT

  • hematological parameters [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    complete blood count


Estimated Enrollment: 20
Study Start Date: May 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hemin
Panhematin®, Ovation Pharmaceuticals, Deerfield, IL
Biological: Hemin
10 iv infusions for 8 weeks
Other Name: Panhematin®, (Ovation Pharmaceuticals, Deerfield, IL)
Placebo Comparator: Albumin (25%) Biological: Albumin (25%)
10 iv infusions for 8 weeks
Other Name: Albumin (Human) 25% Solution manufactured by CSL Behring.

Detailed Description:

Heme oxygenase 1 (HO-1) is an enzyme which protects cells from physical, chemical, and biologic stress. In mice with diabetes and slow gastric emptying, hemin increases HO-1 activity and improves gastric emptying. Hemin is produced from red blood cells and is approved by the Food and Drug Administration for treating acute porphyria, which is an inherited condition caused by an enzyme deficiency. Hemin is not approved by the Food and Drug Administration for treating gastroparesis.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206582

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Adil E Bharucha, MBBS, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Adil E. Bharucha, M.B.B.S., M.D (Principal Investigator), Mayo Clinic
ClinicalTrials.gov Identifier: NCT01206582     History of Changes
Other Study ID Numbers: 09-000129
Study First Received: September 20, 2010
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Gastroparesis
Digestive System Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms
Stomach Diseases

ClinicalTrials.gov processed this record on October 21, 2014