This trial is active, not recruiting.

Conditions gastroparesis, diabetes mellitus
Treatments hemin, albumin (25%)
Phase phase 2
Sponsor Mayo Clinic
Start date May 2010
End date December 2015
Trial size 20 participants
Trial identifier NCT01206582, 09-000129


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Panhematin®, Ovation Pharmaceuticals, Deerfield, IL
hemin Panhematin®, (Ovation Pharmaceuticals, Deerfield, IL)
10 iv infusions for 8 weeks
(Placebo Comparator)
albumin (25%) Albumin (Human) 25% Solution manufactured by CSL Behring.
10 iv infusions for 8 weeks

Primary Outcomes

- Heme-oxygenase 1 (HO-1) protein concentration
time frame: 8 weeks
- HO-1 activity
time frame: 8 weeks
Gastric emptying by scintigraphy
time frame: 8 weeks (or last completed assessment)
- Gastrointestinal symptoms
time frame: 8 weeks

Secondary Outcomes

HO-1 protein concentration
time frame: 1, 3, 4, 7, 14, 21, 28, 35, 42, and 49 days
Gastric emptying
time frame: days 1, 4, 7, 14, 21, 28, 35, 42, and 49
Gastrointestinal symptoms
time frame: days 1, 4, 7, 14, 21, 28, 35, 42, and 49.
Autonomic functions
time frame: 8 weeks
Serum chemistry
time frame: 8 weeks
coagulation parameters
time frame: 8 weeks
hematological parameters
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title A Pilot Study of Hemin Therapy for Gastroparesis
Principal investigator Adil E Bharucha, MBBS, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Mayo Clinic.