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Sorbitol+Phenylephrine

Phase 1

Acute Pain | Small molecule | Pain |BioLineRx Ltd.|Last Updated: Apr 15, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

Sorbitol+Phenylephrine · 1 trial · 1 indication

Phase 1 1
NCT00374881A Study of the Safety and Efficacy of Combination Therapy With Morphine, Phenylephrine and Sorbitol in Human SubjectsAcute Pain
COMPLETED9 Analytics
PHASE1COMPLETED
A Study of the Safety and Efficacy of Combination Therapy With Morphine, Phenylephrine and Sorbitol in Human Subjects
Acute PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety
8 hours

Secondary Endpoints

Efficacy
4 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORMorphine High Dose
2PLACEBO_COMPARATORMorphine Low Dose
3PLACEBO_COMPARATORSorbitol Phenylephrine
4EXPERIMENTALSorbitol high concentration+Phenylephrine+Morphine
5EXPERIMENTALSorbitol low concentration+Phenylephrine+Morphine

Interventions

NameTypeDescription
MorphineDRUGMorphine
Sorbitol+PhenylephrineDRUGSorbitol+Phenylephrine
Sorbitol+Phenylephrine+MorphineDRUGSorbitol+Phenylephrine+Morphine
Sorbitol low concentration+Phenylephrine+MorphineDRUGSorbitol low concentration+Phenylephrine+Morphine
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Ability to provide written informed consent * Healthy male or female between 18 and 40 years of age, inclusive. * Women have to test negative for pregnancy. * Body weight within 15% of ideal body weight based on Metropolitan Life assurance tables. * No concomitant medications ...

Countries:Israel
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Competitive Landscape -Acute Kidney Injury 14 trials (matched to "Acute Pain")

Frequently asked questions about Sorbitol+Phenylephrine

What is Sorbitol+Phenylephrine used for?

Sorbitol+Phenylephrine is an investigational small molecule combination being studied for the treatment of acute pain. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being developed by BioLineRx Ltd. (NASDAQ: BLRX).

How does Sorbitol+Phenylephrine work?

Sorbitol+Phenylephrine combines sorbitol, a sugar alcohol, with phenylephrine, a decongestant and vasoconstrictor. The combination is being studied for its potential to enhance the effects of morphine in managing acute pain. The exact mechanism of action for this combination in pain relief is under investigation.

Who makes Sorbitol+Phenylephrine?

Sorbitol+Phenylephrine is being developed by BioLineRx Ltd., a biopharmaceutical company traded on NASDAQ under the ticker symbol BLRX. The company is conducting clinical trials to evaluate the safety and efficacy of this combination therapy for acute pain.

What phase is Sorbitol+Phenylephrine in?

Sorbitol+Phenylephrine is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for its safety and efficacy in treating acute pain, with one completed Phase 1 trial.

What clinical trials is Sorbitol+Phenylephrine in?

Sorbitol+Phenylephrine has one completed clinical trial registered under NCT00374881, titled "A Study of the Safety and Efficacy of Combination Therapy With Morphine, Phenylephrine and Sorbitol in Human Subjects." This Phase 1, randomized, double-blind, placebo-controlled study enrolled 9 healthy volunteers in Israel.

Is Sorbitol+Phenylephrine the same as phenylephrine alone?

No, Sorbitol+Phenylephrine is a combination product that contains both sorbitol and phenylephrine. It is being studied in combination with morphine for acute pain. Phenylephrine alone is a decongestant, but the combination with sorbitol is being investigated for a different purpose in pain management.