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

This study has been completed.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recordati Rare Diseases
Information provided by (Responsible Party):
Adil Bharucha, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01206582
First received: September 20, 2010
Last updated: January 5, 2016
Last verified: January 2016
Results First Received: November 21, 2015  
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
Conditions: Gastroparesis
Diabetes Mellitus
Interventions: Biological: Hemin
Biological: Albumin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at Mayo Clinic in Rochester, Minnesota between Mayo 2010 and November 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hemin Panhematin®, Ovation Pharmaceuticals, Deerfield, Illinois (IL). Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
Albumin 10 iv infusions for 8 weeks

Participant Flow:   Overall Study
    Hemin     Albumin  
STARTED     11     9  
COMPLETED     9     7  
NOT COMPLETED     2     2  
Withdrew prior to study                 1                 0  
Discontinued intervention before week 8                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Hemin Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
Albumin 10 iv infusions for 8 weeks
Total Total of all reporting groups

Baseline Measures
    Hemin     Albumin     Total  
Number of Participants  
[units: participants]
  11     9     20  
Age  
[units: years]
Mean (Standard Deviation)
  45.9  (14.4)     35.2  (14.9)     41.1  (15.3)  
Gender  
[units: participants]
     
Female     9     9     18  
Male     2     0     2  
Region of Enrollment  
[units: participants]
     
United States     11     9     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Venous Plasma Heme-oxygenase 1 (HO1) Protein Concentration   [ Time Frame: baseline, day 3, day 7, day 56 ]

2.  Primary:   Venous Monocyte HO1 Activity   [ Time Frame: baseline, Day 3, Day 7, Day 56 ]

3.  Primary:   Gastric Emptying Half-time   [ Time Frame: baseline, day 3, day 7, day 56 ]

4.  Secondary:   Gastrointestinal Symptoms   [ Time Frame: baseline, 8 weeks ]

5.  Secondary:   Autonomic Functions   [ Time Frame: baseline, Day 56 ]

6.  Secondary:   Serum Creatinine   [ Time Frame: baseline, Day 4, Day 7, Day 56 ]

7.  Secondary:   Prothrombin Time   [ Time Frame: baseline, Day 4, Day 7, Day 56 ]

8.  Secondary:   Activated Partial Thromboplastin Time (APTT)   [ Time Frame: baseline, Day 4, Day 7, Day 56 ]

9.  Secondary:   Hemoglobin   [ Time Frame: baseline, Day 4, Day 7, Day 56 ]

10.  Secondary:   Erythrocyte Count   [ Time Frame: baseline, Day 4, Day 7, Day 56 ]

11.  Secondary:   Leukocyte and Platelet Counts   [ Time Frame: baseline, Day 4, Day 7, Day 56 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Adil E. Bharucha
Organization: Mayo Clinic
phone: 507-284-6439
e-mail: bharucha.adil@mayo.edu


No publications provided


Responsible Party: Adil Bharucha, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01206582     History of Changes
Other Study ID Numbers: 09-000129
P01DK068055 ( US NIH Grant/Contract Award Number )
UL1TR000135 ( US NIH Grant/Contract Award Number )
Study First Received: September 20, 2010
Results First Received: November 21, 2015
Last Updated: January 5, 2016
Health Authority: United States: Food and Drug Administration