Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00044044 · ClinicalTrials.gov registry record · Phase 2
A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia
A Phase 2 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 2
- Development phase
- 356
- Enrollment target
NCT00044044: Completed Phase 2 study, sponsored by Sumitomo Pharma America.
NCT00044044 is a Phase 2 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 356 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (168% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00044044, a Phase 2 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 356 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.
Primary Outcome
The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.
Interventions
- DRUG Placebo
- DRUG Lurasidone 80 mg
- DRUG Lurasidone 20 mg
- DRUG Lurasidone 40mg
- DRUG Haloperidol 10mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2002-07 |
| Est. Completion | 2003-05 |
| Phase | Phase 2 |
What the finished NCT00044044 record still lists
NCT00044044 is an interventional study that assigns participants to a tested intervention. The registered 356 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (168% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00044044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00044044 about?
NCT00044044 is a clinical study titled "A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia". The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.
What is the current status of trial NCT00044044?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 356 participants. The study started on 2002-07. Estimated completion is 2003-05.
What interventions are being tested in trial NCT00044044?
The interventions under investigation include: Placebo (DRUG), Lurasidone 80 mg (DRUG), Lurasidone 20 mg (DRUG), Lurasidone 40mg (DRUG), Haloperidol 10mg (DRUG).
Who is sponsoring clinical trial NCT00044044?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00044044's enrollment target sits among peer trials
356 128th of 2000 higher than 1,873 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06077838 · 356 participants · NA
RELAXaHEAD for Headache Patients (Phase III)
- NCT06293469 · 356 participants · NA
Accelerated Flap Coverage in Severe Lower Extremity Trauma
- NCT06958328 · 356 participants · Phase 3
Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer
- NCT06960993 · 356 participants · NA
Mosaic Trial for Stem Cell Transplant Recipients
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia