The Effect of Chloroquine in the Treatment of Patients With Dengue
Sponsor
University of Sao Paulo (Other)
Overall Status
Unknown status
CT.gov ID
NCT00849602
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
132
1
2
16
8.3
Study Details
Study Description
Brief Summary
The objective of this study was to evaluate the effect of chloroquine in the treatment of patients with dengue.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
132 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect of Chloroquine in the Treatment of Patients With Dengue
Study Start Date
:
Feb 1, 2008
Anticipated Primary Completion Date
:
May 1, 2008
Anticipated Study Completion Date
:
Jun 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: 1
|
Drug: Placebo
Placebo bid for three days
|
| Active Comparator: 2
|
Drug: Chloroquine
Chloroquine bid for three days
|
Outcome Measures
Primary Outcome Measures
- Duration of the disease [one week]
Secondary Outcome Measures
- Intensity and days of fever and symptoms [one week]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients suspected of having dengue disease
-
Patients were included in the study if they presented with fever and at least two other symptoms, such as:
-
headache
-
pain behind the eyes
-
muscle and bone or joint pains
-
nausea
-
vomiting
-
rash associated to dengue for less than 72 hours
Exclusion Criteria:
-
Pregnant
-
Younger than 18-years old
-
Either cardiac or neurologic disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | São Paulo University Medical School at Ribeirão Preto | Ribeirão Preto | SP | Brazil | 14048.900 |
Sponsors and Collaborators
- University of Sao Paulo
- Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
- Principal Investigator: Benedito AL Fonseca, PhD, São Paulo University Medical School at Ribeirão Preto
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00849602
Other Study ID Numbers:
- BALF-01
First Posted:
Feb 24, 2009
Last Update Posted:
Feb 24, 2009
Last Verified:
Feb 1, 2009