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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR PROCAINE HYDROCHLORIDE


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All Clinical Trials for procaine hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00189384 ↗ Efficacy Study of Community-Based Treatment of Serious Bacterial Infections in Young Infants Unknown status Aga Khan University Phase 3 2003-11-01 Approximately one-third of neonatal deaths in developing countries are due to infections acquired through the birth canal and/or exposure to an unclean environment soon after birth. Current World Health Organization recommendations for the management of infants younger than 2 months of age who have serious bacterial infections involve hospitalization and parenteral therapy for at least 10 days with antibiotic regimens containing penicillin or ampicillin combined with an aminoglycoside.However, in many settings throughout the developing world, this is not currently possible, nor is this standard of care likely to be feasible in the near future. Several studies have reported that for a variety of sociocultural reasons many families are unable or unwilling to access hospital-based care and their sick young infants do not get hospitalized, and instead, receive a variety of home-based antibiotic therapies, or none at all. In our community field sites, approximately 70% of families refuse hospital referral for a sick newborn, despite provision of transport. Thus, there is an urgent need to define the role of community/first-level facility-based care versus hospitalization for the management of young infants with serious bacterial infections, and the potential for community-based parenteral antibiotics as an alternative strategy in resource poor areas with high neonatal mortality rates. Bang and colleagues have demonstrated significant reductions in neonatal mortality from infections in an underdeveloped rural district in Maharashtra, India by a field-based case management approach which used oral cotrimoxazole and intramuscular gentamicin given for 7 days as treatment for neonates with sepsis. This study is an equivalence randomized controlled trial (RCT) comparing once daily IM ceftriaxone injection to once daily IM procaine penicillin and gentamicin injection, to once daily intramuscular gentamicin injection and twice daily oral cotrimoxazole, given for 7 days in babies with clinically-diagnosed possible serious bacterial infection (pneumonia, or sepsis with or without local infections such as skin or umbilical infections) whose families refused referral to a hospital. After supplementary informed consent, patients meeting specific inclusion and exclusion criteria are randomly allocated to one of the three regimens being tested. The study hypothesis is that all 3 regimens will perform equally well in the treatment of sepsis in a first-level facility setting.
NCT00299338 ↗ A Dose Response and Safety Study of Procaine HCl in HIV-Infected Patients Completed Samaritan Pharmaceuticals, Inc Phase 1/Phase 2 1997-09-01 This a Phase I/II non-randomized, open-label clinical study of 8 weeks duration using SP01A in HIV positive patients on a stable antiretroviral regimen. Dose response and safety associated with oral administration of four doses (200 mg, 400 mg, 600 mg, and 800 mg daily) of SP01A will be studied in a total of 24 study subjects. In addition, six HIV-negative subjects will be recruited as a control for cortisol secretion only and will not receive study medication.
NCT00299897 ↗ SP01A: The Study of an Oral Entry Inhibitor in Treatment-Experienced HIV Patients Unknown status Samaritan Pharmaceuticals, Inc Phase 2 2006-03-01 This is a 28-day, multi-center, placebo-controlled study designed to look at the dose response, efficacy, and safety of SP01A, given as a pill to be swallowed, in the treatment of HIV-infected subjects. Samaritan has discovered that SP01A affects cholesterol binding, which is directly implicated in the pathogenesis of HIV. It has also been established that drugs of this nature exert an anti-HIV effect in-vitro. These data suggest that SP01A has the potential to reduce HIV virus replication. One measurement of an HIV infected person's risk of progressing to AIDS is the number of viral particles of HIV in their blood (called a "viral load"). This study is designed to see if SP01A will lower the amount of HIV in an infected individual's blood. Patients will be assigned by chance to 1 of 4 groups. Neither the patient nor the study doctor or nurse will know which dose of the study drug the patient is taking or if he/she is receiving the placebo (a capsule that looks like the study drug but does not contain any active ingredient). Study drug administration will continue for 28 days. At the end of the 28-day study, the patient will be offered testing of his/her virus for resistance to approved drugs (genotype).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for procaine hydrochloride

Condition Name

Condition Name for procaine hydrochloride
Intervention Trials
Sepsis 3
HIV Infections 2
Metastatic Cancer 1
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Condition MeSH

Condition MeSH for procaine hydrochloride
Intervention Trials
Sepsis 3
HIV Infections 2
Toxemia 2
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Clinical Trial Locations for procaine hydrochloride

Trials by Country

Trials by Country for procaine hydrochloride
Location Trials
United States 6
Pakistan 2
China 2
France 1
Brazil 1
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Trials by US State

Trials by US State for procaine hydrochloride
Location Trials
California 2
Oregon 1
Tennessee 1
Pennsylvania 1
Florida 1
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Clinical Trial Progress for procaine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for procaine hydrochloride
Clinical Trial Phase Trials
Phase 4 1
Phase 3 3
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for procaine hydrochloride
Clinical Trial Phase Trials
Completed 6
Unknown status 6
Not yet recruiting 1
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Clinical Trial Sponsors for procaine hydrochloride

Sponsor Name

Sponsor Name for procaine hydrochloride
Sponsor Trials
Aga Khan University 2
Samaritan Pharmaceuticals, Inc 2
McGill University Health Centre/Research Institute of the McGill University Health Centre 1
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Sponsor Type

Sponsor Type for procaine hydrochloride
Sponsor Trials
Other 20
Industry 3
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