Last reviewed · How we verify
IV Placebo (Saline)
IV saline placebo has no active pharmacological mechanism; it is a control comparator consisting of sterile sodium chloride solution.
IV saline placebo has no active pharmacological mechanism; it is a control comparator consisting of sterile sodium chloride solution. Used for Clinical trial control / placebo comparator (not a therapeutic indication).
At a glance
| Generic name | IV Placebo (Saline) |
|---|---|
| Also known as | Saline |
| Sponsor | Allergan |
| Modality | Small molecule |
| Phase | FDA-approved |
Mechanism of action
Intravenous saline (0.9% sodium chloride) is an isotonic crystalloid fluid used as a vehicle or placebo control in clinical trials. It serves no therapeutic purpose beyond maintaining fluid balance and is used to blind study participants and investigators to treatment allocation. Any observed clinical effects in the placebo arm are attributable to natural disease progression, regression to the mean, or placebo response rather than pharmacological action.
Approved indications
- Clinical trial control / placebo comparator (not a therapeutic indication)
Common side effects
- Injection site reactions (pain, erythema)
- Fluid overload (with excessive volume)
- Hyponatremia (rare, with very high volumes)
Key clinical trials
- Magnesium Supplementation in Advanced Non-small Cell Lung Cancer (NSCLC) (PHASE2, PHASE3)
- Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1) (PHASE1)
- MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM) (PHASE3)
- A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade (PHASE2)
- Improving Preterm Kidney Outcomes With Caffeine (PHASE2)
- A Study of Adeno-Associated Virus Serotype 8-Mediated Gene Transfer of Glucose-6-Phosphatase in Patients With Glycogen Storage Disease Type Ia (GSDIa) (PHASE3)
- Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2) (PHASE1, PHASE2)
- Investigation of the NMDA Antagonist Ketamine as a Treatment for Tinnitus (PHASE2)
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:
- IV Placebo (Saline) CI brief — competitive landscape report
- IV Placebo (Saline) updates RSS · CI watch RSS
- Allergan portfolio CI