Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004831
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-08
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:
OBJECTIVES
I Determine the efficacy of cysteine hydrochloride in preventing or decreasing photosensitivity in patients with erythropoietic protoporphyria
I Determine the efficacy of cysteine hydrochloride in preventing or decreasing photosensitivity in patients with erythropoietic protoporphyria
Detailed Description:
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SLRH-CU-FDR000996-EF | None | None | None |
| BWH-FDR000996-EF | None | None | None |