|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Adventrx Pharmaceuticals |
|---|---|
| Collaborator: |
CytRx |
| Information provided by (Responsible Party): | Adventrx Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00004408 |
Purpose
OBJECTIVES: I. Assess the efficacy of poloxamer 188 in reducing the duration of painful vaso-occlusive crisis in patients with sickle cell disease.
II. Assess the effect of poloxamer 188 on duration and intensity of pain, total analgesic use, and length of hospitalization of these patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Sickle Cell Anemia |
Drug: poloxamer 188 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment |
| Estimated Enrollment: | 300 |
| Study Start Date: | November 1997 |
| Study Completion Date: | November 1999 |
| Primary Completion Date: | November 1999 (Final data collection date for primary outcome measure) |
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to hydroxyurea use.
Patients are randomized to treatment poloxamer 188 or placebo. Treatment begins within 12 hours of presentation with crisis. Patients receive poloxamer 188 or placebo by continuous infusion for 48 hours. Pain is assessed before, during, and after treatment.
Patients are followed on days 7-14 and 28-35.
Eligibility| Ages Eligible for Study: | 10 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Contacts and Locations
More Information
| Responsible Party: | Adventrx Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00004408 History of Changes |
| Other Study ID Numbers: | 199/13296, CYTRX-C97-1248, CYTRX-FDR001433 |
| Study First Received: | October 18, 1999 |
| Last Updated: | February 8, 2012 |
| Health Authority: | United States: Federal Government |
|
disease-related problem/condition genetic diseases and dysmorphic syndromes hematologic disorders |
pain rare disease sickle cell anemia |
|
Anemia Anemia, Sickle Cell Hematologic Diseases Anemia, Hemolytic, Congenital |
Anemia, Hemolytic Hemoglobinopathies Genetic Diseases, Inborn |