Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125788
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2005-08-01
Brief Title:
L-Glutamine Therapy for Sickle Cell Anemia and Sickle ß0 Thalassemia
Sponsor:
Emmaus Medical Inc
Organization:
Emmaus Medical Inc
Study Overview
Official Title:
A Phase II Prospective Randomized Double-Blind Placebo-Controlled Parallel-Group Multicenter Study of L Glutamine Therapy for Sickle Cell Anemia and Sickle ß0-Thalassemia
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to evaluate the effects of L-glutamine as a therapy for sickle cell anemia and sickle ß0-thalassemia as evaluated by the number of occurrences of sickle cell crises
Detailed Description:
The primary purpose of this study is to evaluate the effectiveness of oral L-glutamine in the therapy of sickle cell anemia and sickle ß0-thalassemia
The secondary purpose is to assess the effect of L-glutamine frequency of hospitalizations for sickle cell pain frequency of emergency room visits for sickle cell pain energy and appetite levels narcotics usage
Methodology
By site patients will be randomized to L-glutamine or placebo in a 11 ratio after a 4-week screening period Patients will undergo 48 weeks of treatment with dosing BID orally with dose calculated according to patient weight Patient visits will occur every 4 weeks After 48 weeks of treatment dose will be tapered to zero within 3 weeks A final evaluation visit will occur 2 weeks after last dose
The secondary purpose is to assess the effect of L-glutamine frequency of hospitalizations for sickle cell pain frequency of emergency room visits for sickle cell pain energy and appetite levels narcotics usage
Methodology
By site patients will be randomized to L-glutamine or placebo in a 11 ratio after a 4-week screening period Patients will undergo 48 weeks of treatment with dosing BID orally with dose calculated according to patient weight Patient visits will occur every 4 weeks After 48 weeks of treatment dose will be tapered to zero within 3 weeks A final evaluation visit will occur 2 weeks after last dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None