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NCT03160521 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of Risperidone in Situ Microparticle (ISM)® in Patients With Acute Schizophrenia
A Phase 3 study, sponsored by Rovi Pharmaceuticals Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 438
- Enrollment target
NCT03160521 is a Phase 3 study that has completed, run by Rovi Pharmaceuticals Laboratories. The registered enrollment target is 438 participants.
The verdict
NCT03160521, a Phase 3 study, has completed, sponsored by Rovi Pharmaceuticals Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 438 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of intramuscular (IM) injections of Risperidone ISM® (75 or 100 mg) or placebo, in patients with acute exacerbation of schizophrenia.
Interventions
- DRUG Risperidone ISM 75 mg
- DRUG Risperidone ISM 100 mg
- DRUG Placebo of Risperidone ISM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 438 participants |
| Start Date | 2017-06-02 |
| Est. Completion | 2018-12-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03160521
The ClinicalTrials.gov registry entry for NCT03160521 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 438 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rovi Pharmaceuticals Laboratories, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Risperidone ISM 75 mg is the first listed.
NCT03160521 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03160521 about?
NCT03160521 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Risperidone in Situ Microparticle (ISM)® in Patients With Acute Schizophrenia". This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of intramuscular (IM) injections of Risperidone ISM® (75 or 100 mg) or placebo, in patients with acute exacerbation of schizophrenia.
What is the current status of trial NCT03160521?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 438 participants. The study started on 2017-06-02. Estimated completion is 2018-12-17.
What interventions are being tested in trial NCT03160521?
The interventions under investigation include: Risperidone ISM 75 mg (DRUG), Risperidone ISM 100 mg (DRUG), Placebo of Risperidone ISM (DRUG).
Who is sponsoring clinical trial NCT03160521?
This trial is sponsored by Rovi Pharmaceuticals Laboratories, which has 5 total clinical trials registered on ClinicalTrials.gov.
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