Last reviewed · How we verify
Placebo matching nitrofurantoin
This is a placebo control formulation matching the appearance and characteristics of nitrofurantoin, used in clinical trials to provide a blinded comparator.
This is a placebo control formulation matching the appearance and characteristics of nitrofurantoin, used in clinical trials to provide a blinded comparator. Used for Control arm in phase 3 clinical trials of nitrofurantoin (likely urinary tract infection or related indication).
At a glance
| Generic name | Placebo matching nitrofurantoin |
|---|---|
| Sponsor | GlaxoSmithKline |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Placebo matching nitrofurantoin is not an active pharmaceutical agent but rather an inert formulation designed to be indistinguishable from nitrofurantoin in phase 3 clinical trials. It serves as a control arm to assess the true efficacy of nitrofurantoin by comparing outcomes between patients receiving active drug versus placebo under blinded conditions.
Approved indications
- Control arm in phase 3 clinical trials of nitrofurantoin (likely urinary tract infection or related indication)
Common side effects
Key clinical trials
- Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections (PHASE1)
- Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI) (PHASE3)
- A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI) (PHASE3)
- Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery (PHASE4)
- Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery (PHASE4)
- Antibiotic Prophylaxis in Children With Pyelonephritis (PHASE3)
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:
- Placebo matching nitrofurantoin CI brief — competitive landscape report
- Placebo matching nitrofurantoin updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI