Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo
This study has been terminated.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00570063
First received: December 6, 2007
Last updated: September 25, 2009
Last verified: September 2009
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Purpose
To assess the efficacy and safety of an investigational compound PF-02545920 for the treatment of schizophrenia. PF-02545920 will be more effective than placebo in reducing symptoms associated with schizophrenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: PF-02545920 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Multicenter, Double Blind, Randomized, Fixed Dose, Parallel Group, 3 Week Inpatient Treatment Study To Evaluate The Safety, Efficacy And Pharmacokinetics Of PF-02545920 Compared With Placebo In The Treatment Of Acute Exacerbation Of Schizophrenia |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from baseline to endpoint on the Positive and Negative Symptom Assessment Scale (PANSS). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- ECG and ESRS-A as safety measures of change from baseline to endpoint [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline to endpoint on the PANSS subscales (positive, negative and general psychopathology [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Changes on the Clinical global impression scales (Severity and Improvement) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters (how the body handles the drug) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | November 2007 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 2
Matching placebo tablets taken twice a day by mouth for 21 days
|
Drug: Placebo
Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days.
|
|
Placebo Comparator: 1
PF-02545920 15 mg tablets taken twice a day by mouth for 21 days
|
Drug: PF-02545920
Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have a current diagnosis of schizophrenia.
- Increase in symptoms over the past 2-4 weeks.
- Willing to remain inpatients for the duration of the trial.
Exclusion Criteria:
- Evidence or history of clinically significant medical problems.
- Females of childbearing potential.
- A primary psychiatric diagnosis other than schizophrenia.
- A diagnosis of substance abuse or dependence in the last 6 months.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570063
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Glendale, California, United States, 91206 | |
| Pfizer Investigational Site | |
| Lemon Grove, California, United States, 91945 | |
| Pfizer Investigational Site | |
| Paramount, California, United States, 90723 | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92123 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06519 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Willingboro, New Jersey, United States, 08046 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 93101 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00570063 History of Changes |
| Other Study ID Numbers: | A8241006 |
| Study First Received: | December 6, 2007 |
| Last Updated: | September 25, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Schizophrenia, acute exacerbation, and PF-02545920 |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013