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This local registration study is to confirm the hypothesis of the efficacy, tolerability and safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in schizophrenia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intramuscular ziprasidone | Experimental |
| |
| Intramuscular haloperidol | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramuscular ziprasidone mesylate | Drug | The recommended dose is 10 to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day for 3 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours | BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126. Change: score at final visit minus score at baseline. | Baseline, 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| BPRS Agitation Subscale Response at 72 Hours | The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. A response was defined as a > 30 percent reduction from baseline in BPRS agitation subscale score. | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Baoding | Hebei | 071000 | China | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23422376 | Derived | Zhang H, Wang G, Zhao J, Xie S, Xu X, Shi J, Deng H, Li K, Gao C, Wang X, Vanderburg D, Pan S, Tang H, Shu L, Karayal ON. Intramuscular ziprasidone versus haloperidol for managing agitation in Chinese patients with schizophrenia. J Clin Psychopharmacol. 2013 Apr;33(2):178-85. doi: 10.1097/JCP.0b013e3182839612. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ziprasidone | An initial intramuscular (IM) injection of ziprasidone 10 or 20 milligram (mg). Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours possible treatment. |
| FG001 | Haloperidol |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Intramuscular haloperidol | Drug | The haloperidol group will receive an initial intramuscular injection of haloperidol 5mg, following on which 5mg haloperidol may be repeated every 4-8 hours to a maximum of 20 mg /day for 3 days. |
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| Change From Baseline in BPRS Agitation Subscale Score at 72 Hours | The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. Change: score at final visit minus score at baseline. | Baseline, 72 hours |
| Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | 72 hours |
| Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours | CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. | Baseline, 72 hours |
| Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours | BARS measures the degree of agitated behavior using a 7-point scale describing increasing levels of activity (1 =difficult or unable to rouse; 2 = asleep but responds normally to verbal or physical contact; 3 = drowsy, appears sedated; 4 = quiet and awake [normal level of activity]; 5 = signs of overt [physical or verbal] activity, calms down with instructions; 6 = extremely or continuously active, not requiring restraint; 7 = violent, requires restraint. | Baseline, 72 hours |
| Wuhan |
| Hubei |
| 430060 |
| China |
| Pfizer Investigational Site | Kunming | Yunnan | 650032 | China |
| Pfizer Investigational Site | Beijing | 100083 | China |
| Pfizer Investigational Site | Beijing | 100088 | China |
| Pfizer Investigational Site | Changsha | 410011 | China |
| Pfizer Investigational Site | Guangzhou | 510370 | China |
| Pfizer Investigational Site | Nanjing | 210029 | China |
| Pfizer Investigational Site | Xi'an | China |
An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ziprasidone | An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment. |
| BG001 | Haloperidol | An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours | BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126. Change: score at final visit minus score at baseline. | Per protocol (PP) population = Full Analysis Set (FAS) subjects (ie, randomized subjects who took at least one dose of study medication) who provided a baseline and 72 hour BPRS total score and did not deviate from the protocol in a significant manner. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, 72 hours |
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| Secondary | BPRS Agitation Subscale Response at 72 Hours | The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. A response was defined as a > 30 percent reduction from baseline in BPRS agitation subscale score. | FAS. Missing data were replaced by last observation carried forward (LOCF). | Posted | Number | participants | 72 hours |
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| Secondary | Change From Baseline in BPRS Agitation Subscale Score at 72 Hours | The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. Change: score at final visit minus score at baseline. | FAS. Missing data were replaced by LOCF. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, 72 hours |
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| Secondary | Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | FAS. Missing data were replaced by LOCF. | Posted | Least Squares Mean | Standard Error | scores on a scale | 72 hours |
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| Secondary | Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours | CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. | FAS. Missing data were replaced by LOCF. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, 72 hours |
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| Secondary | Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours | BARS measures the degree of agitated behavior using a 7-point scale describing increasing levels of activity (1 =difficult or unable to rouse; 2 = asleep but responds normally to verbal or physical contact; 3 = drowsy, appears sedated; 4 = quiet and awake [normal level of activity]; 5 = signs of overt [physical or verbal] activity, calms down with instructions; 6 = extremely or continuously active, not requiring restraint; 7 = violent, requires restraint. | FAS. Missing data were replaced by LOCF. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, 72 hours |
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ziprasidone | An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment. | 0 | 189 | 36 | 189 | ||
| EG001 | Haloperidol | An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours. | 0 | 187 | 107 | 187 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Dystonia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Extrapyramidal disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Pyramidal tract syndrome | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
| D006220 | Haloperidol |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Title | Measurements |
|---|---|
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| 45 to 64 years |
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| > = 65 years |
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| Male |
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