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Isotonic Saline 0.9% (Placebo)
Isotonic saline 0.9% is a physiologically balanced salt solution that serves as an inert vehicle for drug delivery or fluid replacement with no active pharmacological mechanism.
Isotonic saline 0.9% is a physiologically balanced salt solution that serves as an inert vehicle for drug delivery or fluid replacement with no active pharmacological mechanism. Used for Placebo control in clinical trials.
At a glance
| Generic name | Isotonic Saline 0.9% (Placebo) |
|---|---|
| Sponsor | The Hospital for Sick Children |
| Modality | Small molecule |
| Phase | FDA-approved |
Mechanism of action
Isotonic saline contains sodium chloride at a concentration (0.9%) that matches the osmolarity of human blood plasma, making it isotonic and suitable for intravenous, intranasal, or topical administration. As a placebo, it has no therapeutic mechanism of action and is used as a control comparator in clinical trials to assess the efficacy of active investigational drugs. Its primary function is to maintain fluid balance and electrolyte homeostasis when used clinically, but in placebo-controlled studies it serves solely as a blinded control.
Approved indications
- Placebo control in clinical trials
Common side effects
- Hypernatremia (with excessive use)
- Fluid overload (with excessive use)
- Local irritation at injection site
Key clinical trials
- PRP Injection Into the Sacroiliac Joint After Ipsilateral THA: Effects on Early Recovery and Function (SIJ-THA Randomized Trial) (NA)
- Pulse Glucocorticoid Therapy in Patients With ST-Segment Elevation Myocardial Infarction (PHASE2)
- Magnesium Supplementation in Advanced Non-small Cell Lung Cancer (NSCLC) (PHASE2, PHASE3)
- Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection (PHASE2)
- Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1) (PHASE1)
- A Phase 3 Study of Zodasiran in Adolescent and Adult Subjects With Homozygous Familial Hypercholesterolemia (YOSEMITE) (PHASE3)
- MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM) (PHASE3)
- Repeated Bilateral Greater Occipital Nerve Blockade in Chronic Migraine and Chronic Tension-Type Headache (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Isotonic Saline 0.9% (Placebo) CI brief — competitive landscape report
- Isotonic Saline 0.9% (Placebo) updates RSS · CI watch RSS
- The Hospital for Sick Children portfolio CI