Trials / Completed
CompletedNCT00002296
The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease
A Multi-Center Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Newport Pharmaceuticals International · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of Isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunological parameters: * Increase in natural killer (NK) cell activity. * Increase in total T-cells (OKT-11). * Increases in absolute number and percentage of T-helper cells (OKT-4).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Inosine pranobex |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00002296. Inclusion in this directory is not an endorsement.