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Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial

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ClinicalTrials.gov Identifier: NCT01796678
Recruitment Status : Completed
First Posted : February 22, 2013
Last Update Posted : July 31, 2013
Sponsor:
Information provided by (Responsible Party):
UCSF Benioff Children's Hospital Oakland

Tracking Information
First Submitted Date  ICMJE February 19, 2013
First Posted Date  ICMJE February 22, 2013
Last Update Posted Date July 31, 2013
Study Start Date  ICMJE September 2000
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
Length of Hospital Stay [ Time Frame: participants will be followed for the duration of hospital stay an expected average of 3-6 days, with re-admission data being collect for up to 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
  • Effect on Pain Score [ Time Frame: participants will be followed for the duration of hospital stay an expected average of 3-6 days ]
  • Total Opioid Use (mg/kg) [ Time Frame: participants will be followed for the duration of hospital stay an expected average of 3-6 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial
Official Title  ICMJE Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial
Brief Summary Vaso-occlusion contributes significantly to morbidity in sickle cell disease (SCD). Vaso-occlusive painful episodes (VOE) are common and debilitating, causing the majority of emergency department visits. Currently efforts to treat painful episodes with use of non-steroidal pain relievers and intravenous narcotics offer symptomatic relief only, without targeting the underlying mechanisms of vaso-occlusion.Investigators have found that an arginine deficiency and low NO bioavailability occurs during painful events in SCD. Since arginine is the obligate substrate for NO production, and an acute deficiency is associated with VOE, investigators hypothesized that arginine supplementation may be a safe and beneficial treatment for sickle cell pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Vaso-occlusive Pain Episodes
Intervention  ICMJE
  • Drug: Arginine
    Other Name: L-arginine, L-arginine-HCL
  • Drug: Placebo
    Saline or Sugar pill was given as placebo
Study Arms  ICMJE
  • Experimental: Arginine
    100 mg/kg T.I.D 3x a day IV or PO
    Intervention: Drug: Arginine
  • Placebo Comparator: Placebo
    Saline or sugar pill
    Intervention: Drug: Placebo
Publications * Morris CR, Kuypers FA, Lavrisha L, Ansari M, Sweeters N, Stewart M, Gildengorin G, Neumayr L, Vichinsky EP. A randomized, placebo-controlled trial of arginine therapy for the treatment of children with sickle cell disease hospitalized with vaso-occlusive pain episodes. Haematologica. 2013 Sep;98(9):1375-82. doi: 10.3324/haematol.2013.086637. Epub 2013 May 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2013)
56
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Established Diagnosis of Sickle Cell Disease(SS,SC,S-beta thal)
  • Admitted to Hospital for pain
  • Pain requiring hospitalization for parenteral narcotics, not attributable to non-sickle cell causes
  • >3 year and older

Exclusion Criteria:

  • Hemoglobin less than 5gm/dL or immediate need for red cell transfusion
  • Hepatic Dysfunction: increased in SGPT to >2x normal value
  • Renal Dysfunction: increased in creatinine to >2x normal value or >1.5
  • Mental status or neurological changes
  • Pregnancy
  • >10 Hospitalizations per year or history of dependance to narcotics
  • Inability to take oral medications or allergy to arginine
  • Inability to use a PCA device
  • < 3 years of age
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01796678
Other Study ID Numbers  ICMJE HL 14386-05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCSF Benioff Children's Hospital Oakland
Study Sponsor  ICMJE UCSF Benioff Children's Hospital Oakland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claudia R Morris, MD Childrens Hospital Oakland
PRS Account UCSF Benioff Children's Hospital Oakland
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP