Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria
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|ClinicalTrials.gov Identifier: NCT00004831|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
I. Determine the efficacy of cysteine hydrochloride in preventing or decreasing photosensitivity in patients with erythropoietic protoporphyria.
|Condition or disease||Intervention/treatment||Phase|
|Erythropoietic Protoporphyria||Drug: cysteine hydrochloride||Not Applicable|
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study.
Patients are randomly assigned to 1 of 2 groups to receive cysteine hydrochloride orally twice daily, 2 capsules with breakfast and 2 with lunch. Group 1 receives cysteine hydrochloride in drug ingestion period 1 followed by placebo in period 2. Group 2 receives placebo in period 1 followed by cysteine hydrochloride in period 2. Both groups ingest placebo for 1 week between the periods. Each drug ingestion period lasts 8 weeks.
Follow up phone calls are made at the end of months 1 and 3. All patients schedule follow up visits at the end of each drug ingestion period.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Study Start Date :||October 1996|
|Study Completion Date :||July 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004831
|Study Chair:||Micheline M Mathews-Roth||St. Luke's-Roosevelt Hospital Center|