SchizophreniaPhase 2NCT00580125
Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia
A Phase 2 study testing PF-00217830 and Aripiprazole in people with Schizophrenia, run by Pfizer at 26 sites in 4 countries.
Trial summary
The objective of this study is demonstrate efficacy and a dose-response in the treatment of acute exacerbation of schizophrenia in comparison to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- PF-00217830 and Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 26 sitesin 4 countries
- Study dates
- Nov 2007to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects with a current DSM-IV axis I diagnosis other than schizophrenia
- Subjects who meet the DSM-IV criteria for psychoactive substance abuse and dependence
- Subjects with a history of treatment resistant schizophrenia
- Females of childbearing potential
Trial locations and contacts
26 sites in 4 countries.
26 sites in 4 countries
United States8 sites
Pfizer Investigational Site
Bridgeton, Missouri, 63044-2588
Pfizer Investigational Site
Brooklyn, New York, 11203
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Florissant, Missouri, 63033
Pfizer Investigational Site
Garden Grove, California, 92845
Pfizer Investigational Site
Saint Charles, Missouri, 63304
Pfizer Investigational Site
Torrance, California, 90502
Pfizer Investigational Site
Washington D.C., District of Columbia, 20016
Ukraine8 sites
Pfizer Investigational Site
Dnipropetrovsk, 49115
Pfizer Investigational Site
Donetsk, 83037
Pfizer Investigational Site
Kharkiv, 61018
Pfizer Investigational Site
Kharkiv, 61068
Pfizer Investigational Site
Kiev, Ukraine, 02660
Pfizer Investigational Site
Kyiv, 01030
Pfizer Investigational Site
Luhansk, 91045
Pfizer Investigational Site
Simferopol, Autonomous Republic of Crimea, 95006
India5 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560 034
Pfizer Investigational Site
Mangalore, Karnataka, 575001
Pfizer Investigational Site
Pune, Maharashtra, 411 004
Pfizer Investigational Site
Pune, 411 030
Pfizer Investigational Site
Udupi, Karnataka, 576 102
Russia5 sites
Pfizer Investigational Site
Gatchina District, Leningradskaya Oblast', 188357
Pfizer Investigational Site
Khot'kovo, 141371
Pfizer Investigational Site
Moscow, 115522
Pfizer Investigational Site
Saint Petersburg, 190121
Pfizer Investigational Site
Saint Petersburg, 194214
About this study
Official title: A Phase 2, Multicenter, Double-Blind, Randomized, Fixed Dose, Parallel Group, 3-Week Inpatient Treatment Study To Evaluate The Dose-Response Relationship, Safety, Efficacy, And Pharmacokinetics Of PF-00217830 Compared With Placebo, Using Aripiprazole As A Positive Control, In The Treatment Of Acute Exacerbation Of Schizophrenia
The objective of this study is demonstrate efficacy and a dose-response in the treatment of acute exacerbation of schizophrenia in comparison to placebo.
- Conditions
- Schizophrenia
- Being tested
- PF-00217830, Placebo, Aripiprazole
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-00217830Drug
PF-00217830 5 mg, oral capsule, once daily for 21 days
PlaceboOther
Placebo, oral capsule, once daily for 21 days
AripiprazoleDrug
Also called Abilify
Aripiprazole 15 mg, oral capsule, once daily for 21 days
PF-00217830Drug
PF-00217830 15 mg, oral capsule, once daily for 21 days
PF-00217830Drug
PF-00217830 2 mg, oral capsule, once daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| A2 | Experimental | Not described Receives: Drug: PF-00217830 |
| A5 | Placebo comparator | Not described Receives: Other: Placebo |
| A4 | Active comparator | Not described Receives: Drug: Aripiprazole |
| A3 | Experimental | Not described Receives: Drug: PF-00217830 |
| A1 | Experimental | Not described Receives: Drug: PF-00217830 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21).
Measured: 5 weeks
Physical examination (Screening, Days 1 and 21), neurological examination (Days 1 and 21), and ECG (Screening, Days 1, 7, 14, 20, 21 and Followup).
Measured: 5 weeks
Positive and Negative Symptom Scale (PANSS) total score.
Measured: Screening, Day 1, 3, 7, 14 and 21
Adverse events (Daily), weight (Screening, Days 1, and 21) and girth (Days 1 and 21), vital signs (Screening, Days 1, 3, 7, 14, 21 and Followup),
Measured: 5 weeks
Extrapyramidal Symptom Rating Scale (Screening, Days 1, 3, 7, 14 and 21) and the Stanford Sleepiness Scale (Days 1, 3, 7, 14 and 21).
Measured: 4 weeks
Secondary outcomes (7)
PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression)
Measured: Screening, Day 1, 3, 7, 14 and 21
PANSS positive, negative, and general psychopathology subscales
Measured: Screening, Day 1, 3, 7, 14 and 21
Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement)
Measured: Screening and Days 1, 3, 7, 14 and 21
NOSIE-30 subscales (irritability, manifest psychosis, personal neatness, retardation, social competence, and social interest) and the GAF.
Measured: Days 1 and 21
Treatment Satisfaction Questionnaire for Medication (TSQM)
Measured: Day 21
Pharmacokinetics
Measured: Days 7, 14, 20, 21, before discharge and Followup
PANSS-derived BPRS core psychosis items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content)
Measured: Screening and Days 1, 3, 7, 14 and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580125
- Sponsor's protocol ID
- A7251006
- Status last verified
- Jan 2011
- First submitted
- 20 Dec 2007
- Last updated
- 18 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Double-Blind, Randomized, Fixed Dose, Parallel Group, 3-Week Inpatient Treatment Study To Evaluate The Dose-Response Relationship, Safety, Efficacy, And Pharmacokinetics Of PF-00217830 Compared With Placebo, Using Aripiprazole As A Positive Control, In The Treatment Of Acute Exacerbation Of Schizophrenia
- ClinicalTrials.gov ID
- NCT00580125
- Acronym / sponsor ID
- A7251006
- Conditions
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is demonstrate efficacy and a dose-response in the treatment of acute exacerbation of schizophrenia in comparison to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A2 | Experimental | Drug: PF-00217830 |
| A5 | Placebo comparator | Other: Placebo |
| A4 | Active comparator | Drug: Aripiprazole |
| A3 | Experimental | Drug: PF-00217830 |
| A1 | Experimental | Drug: PF-00217830 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Subjects with a current DSM-IV axis I diagnosis other than schizophrenia
- Subjects who meet the DSM-IV criteria for psychoactive substance abuse and dependence
- Subjects with a history of treatment resistant schizophrenia
- Females of childbearing potential
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-00217830PF-00217830 5 mg, oral capsule, once daily for 21 days | Drug | A2 |
| PlaceboPlacebo, oral capsule, once daily for 21 days | Other | A5 |
| AripiprazoleAlso: AbilifyAripiprazole 15 mg, oral capsule, once daily for 21 days | Drug | A4 |
| PF-00217830PF-00217830 15 mg, oral capsule, once daily for 21 days | Drug | A3 |
| PF-00217830PF-00217830 2 mg, oral capsule, once daily for 21 days | Drug | A1 |
Primary outcome
Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21).
Time frame: 5 weeks
Physical examination (Screening, Days 1 and 21), neurological examination (Days 1 and 21), and ECG (Screening, Days 1, 7, 14, 20, 21 and Followup).
Time frame: 5 weeks
Positive and Negative Symptom Scale (PANSS) total score.
Time frame: Screening, Day 1, 3, 7, 14 and 21
Adverse events (Daily), weight (Screening, Days 1, and 21) and girth (Days 1 and 21), vital signs (Screening, Days 1, 3, 7, 14, 21 and Followup),
Time frame: 5 weeks
Extrapyramidal Symptom Rating Scale (Screening, Days 1, 3, 7, 14 and 21) and the Stanford Sleepiness Scale (Days 1, 3, 7, 14 and 21).
Time frame: 4 weeks
7 secondary outcomes
PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression)
Time frame: Screening, Day 1, 3, 7, 14 and 21
PANSS positive, negative, and general psychopathology subscales
Time frame: Screening, Day 1, 3, 7, 14 and 21
Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement)
Time frame: Screening and Days 1, 3, 7, 14 and 21
NOSIE-30 subscales (irritability, manifest psychosis, personal neatness, retardation, social competence, and social interest) and the GAF.
Time frame: Days 1 and 21
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: Day 21
Pharmacokinetics
Time frame: Days 7, 14, 20, 21, before discharge and Followup
PANSS-derived BPRS core psychosis items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content)
Time frame: Screening and Days 1, 3, 7, 14 and 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
26 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-00217830 and Aripiprazole in people with Schizophrenia, run by Pfizer at 26 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Ukraine, India, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21). (time frame: 5 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2012.