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Amoxycillin

Phase 3

Non-Severe Pneumonia With Wheeze | Small molecule | Infectious Disease |United Therapeutics Corporation|Last Updated: Dec 5, 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment2,000

FDA Designations

No designations recorded

Clinical trial landscape

Amoxycillin · 1 trial · 1 indication

Phase 3 1
NCT00407394Indiaclen Short Course Amoxycillin Therapy for Pneumonia With WheezeNon-Severe Pneumonia With Wheeze
COMPLETED2,000 Analytics
PHASE3COMPLETED
Indiaclen Short Course Amoxycillin Therapy for Pneumonia With Wheeze
Non-Severe Pneumonia With Wheeze
NCT004073942,000
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Study Endpoints

Primary Endpoints

Clinical Cure: Respiratory rate below age specific cut-off (<50 bpm in infants <12 months and <40 bpm in 12 - 59 months of age).

Secondary Endpoints

Clinical failure: Any signs of severe pneumonia or severe disease; chest in drawing, convulsions, drowsiness or inability to drink at any time; Respiratory rate above age specific cut-off on day 4 or after that; Oxygen saturation on pulse oximetry <90%
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
AmoxycillinDRUG -
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Eligibility Criteria

Age Range2 Months to 59 Months
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Children aged 2-59 months with non-severe pneumonia based on WHO criteria of respiratory rate above the age specific cut-off, audible / ausculatory wheeze, accessible to follow up, whose guardians give written informed consent. Exclusion Criteria: * Children with severe dise...

Countries:India
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Frequently asked questions about Amoxycillin

What is Amoxycillin used for in Non-Severe Pneumonia With Wheeze?

Amoxycillin is being studied for the treatment of Non-Severe Pneumonia With Wheeze. It is an investigational small molecule in Phase 3 clinical development for this indication. The drug is being evaluated in a clinical trial in India involving children as young as 2 months.

Who makes Amoxycillin?

Amoxycillin is being developed by United Therapeutics Corporation, a company traded on the NASDAQ under the ticker UTHR. The company is conducting clinical research on this drug for the treatment of Non-Severe Pneumonia With Wheeze.

What phase is Amoxycillin in?

Amoxycillin is in Phase 3 clinical development for Non-Severe Pneumonia With Wheeze. It is an investigational drug and has not been approved by regulatory authorities for this indication. One Phase 3 trial has been completed.

What clinical trials is Amoxycillin in?

Amoxycillin has one completed Phase 3 clinical trial, identified as NCT00407394, titled 'Indiaclen Short Course Amoxycillin Therapy for Pneumonia With Wheeze'. This trial enrolled 2000 participants in India and studied the drug in patients with Non-Severe Pneumonia With Wheeze.

Is Amoxycillin the same as Indiaclen?

Amoxycillin is the drug being studied in the clinical trial NCT00407394, which is titled 'Indiaclen Short Course Amoxycillin Therapy for Pneumonia With Wheeze'. The trial name includes 'Indiaclen', which may refer to the study or a product name, but the drug itself is Amoxycillin.