Generalized Anxiety DisorderPhase 3NCT00658008
A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1)
A Phase 3 study testing PD 0332334 and Paroxetine in people with Generalized Anxiety Disorder, run by Pfizer at 52 sites in 5 countries.
Trial summary
This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages from 18 to 65, with generalized anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- PD 0332334 and Paroxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 501 participants
- Where
- 52 sitesin 5 countries
- Study dates
- Apr 2008to Mar 2009
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of GAD (Diagnostic and Statistical Manual IV [DSM IV], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM IV) or dysthymic disorder will be allowed in the study.
- Subjects must have a HAM A total score ≥20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of ≥9 and a Raskin Depression Scale score ≤7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.
Who cannot join
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
- Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnosis: Major Depressive Disorder, Obsessive Compulsive Disorder, Panic Disorder, Agoraphobia, Posttraumatic Stress Disorder, Anorexia, Bulimia, Caffeine induced anxiety disorder, Alcohol or substance abuse or dependence unless in full remission for at least 6 months, Social Anxiety Disorder.
- Any of the following past or current DSM-IV Axis I diagnoses: Schizophrenia, Psychotic disorder, Delirium, dementia, amnestic, and other clinically significant cognitive disorders, Bipolar or schizoaffective disorder, Cyclothymic disorder, Dissociative disorders.
- Antisocial or borderline personality disorder.
- Serious suicidal risk per the clinical investigator's judgment.
Trial locations and contacts
52 sites in 5 countries.
52 sites in 5 countries
United States45 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87109
Pfizer Investigational Site
Altamonte Springs, Florida, 32701
Pfizer Investigational Site
Austin, Texas, 78756
Pfizer Investigational Site
Bala-Cynwyd, Pennsylvania, 19004
Pfizer Investigational Site
Baltimore, Maryland, 21208
Pfizer Investigational Site
Bethany, Oklahoma, 73008
Pfizer Investigational Site
Boston, Massachusetts, 02135
Pfizer Investigational Site
Brooklyn, New York, 11235
Pfizer Investigational Site
Burlington, Vermont, 05401
Pfizer Investigational Site
Charlottesville, Virginia, 22903
Pfizer Investigational Site
Charlottesville, Virginia, 22911
Pfizer Investigational Site
Clementon, New Jersey, 08021
Pfizer Investigational Site
Columbia, South Carolina, 29201
Pfizer Investigational Site
Costa Mesa, California, 92626
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Denver, Colorado, 80239
Pfizer Investigational Site
Lake Jackson, Texas, 77566
Pfizer Investigational Site
Las Vegas, Nevada, 89146
Pfizer Investigational Site
Litchfield Park, Arizona, 85340
Pfizer Investigational Site
Maitland, Florida, 32751
Pfizer Investigational Site
Media, Pennsylvania, 19063
Pfizer Investigational Site
Memphis, Tennessee, 38117
Pfizer Investigational Site
Miami, Florida, 33126
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
New York, New York, 10023
Pfizer Investigational Site
Norristown, Pennsylvania, 19401
Pfizer Investigational Site
Norwich, Connecticut, 06360
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
Pasadena, California, 91106
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19136
Pfizer Investigational Site
Raleigh, North Carolina, 27607
Pfizer Investigational Site
Redlands, California, 92374
Pfizer Investigational Site
Saint Charles, Missouri, 63301
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Shreveport, Louisiana, 71104
Pfizer Investigational Site
South Miami, Florida, 33143
Pfizer Investigational Site
Terre Haute, Indiana, 47802
Pfizer Investigational Site
The Bronx, New York, 10454
Pfizer Investigational Site
The Bronx, New York, 10467
Pfizer Investigational Site
Toledo, Ohio, 43609
Pfizer Investigational Site
Toledo, Ohio, 43623
Pfizer Investigational Site
Topeka, Kansas, 66606
Pfizer Investigational Site
Waukesha, Wisconsin, 53188-1660
Pfizer Investigational Site
Willingboro, New Jersey, 08046
Hungary2 sites
Pfizer Investigational Site
Budapest, 1095
Pfizer Investigational Site
Budapest, 1137
Italy2 sites
Pfizer Investigational Site
Catania, 95123
Pfizer Investigational Site
Torino, 10126
South Korea2 sites
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 138-736
About this study
Official title: A Phase 3, Randomized, Double-Blind, Parallel Group, 10-Week Placebo Controlled Fixed Dose Study Of PD 0332334 And Paroxetine Evaluating The Efficacy And Safety Of PD 0332334 For The Treatment Of Generalized Anxiety Disorder
This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages from 18 to 65, with generalized anxiety disorder.
Read the detailed description
Termination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- PD 0332334, Paroxetine, Placebo
- Keywords
- PD 0332334 phase 3 pivotal trial
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD 0332334Drug
Also called imagabalin
Capsules, oral, 175 mg BID, 8 weeks with 2 week taper
PD 0332334Drug
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
PD 0332334Drug
Capsules, oral, 75 mg BID, 8 weeks with 2 week taper
ParoxetineDrug
Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper
PlaceboDrug
Capsules, oral, placebo bid, 8 weeks with 2 week taper
| Study group | Role | What they receive |
|---|---|---|
| PD 0332334 175 mg BID | Experimental | Not described Receives: Drug: PD 0332334 |
| PD 0332334 225 mg BID | Experimental | Not described Receives: Drug: PD 0332334 |
| PD 0332334 75 mg BID | Experimental | Not described Receives: Drug: PD 0332334 |
| Paroxetine 20 mg QD | Active comparator | Not described Receives: Drug: Paroxetine |
| Placebo BID | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment.
Measured: 8 weeks
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study
Measured: 8 weeks
Secondary outcomes (20)
Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)
Measured: 8 weeks
Response rate on the patient-rated PGI-C at week 8
Measured: 8 weeks
Change from baseline to week 8 on the Sheehan Disability Scale subscales
Measured: 8 weeks
Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13)
Measured: 8 weeks
Response rate on the HAM-A at week 1 and week 8
Measured: 8 weeks
Response rate on the clinician-rated CGI-I ate week 1 and week 8
Measured: 8 weeks
Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8
Measured: 8 weeks
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II
Measured: 1 week
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II
Measured: 8 weeks
Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6
Measured: 6 weeks
Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8
Measured: 8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales
Measured: 8 weeks
Remission rate based on the HAM A at Week 8
Measured: 8 weeks
Change from baseline in CGI-S at week 8
Measured: 8 weeks
Change from baseline to week 8 in the QLesQ General Activity Score
Measured: 8 weeks
The "Week 1 Sustained Responder" rate based on the HAM A (where "Week 1 Sustained Responders" are defined as subjects with a 50% or greater improvement from baseline on the HAM A total score at Week 1 that is sustained until the Week 8 visit)
Measured: 1 week
Change from Baseline to Days 2 8 and Weeks 2, 4, 6, 8 on the DAS A (total score)
Measured: 8 weeks
Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score
Measured: 8 weeks
Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary)
Measured: 8 weeks
Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Please see Detailed Description for termination reason.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 501 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
- NCT00658008
- Sponsor's protocol ID
- A5361019
- Status last verified
- Nov 2012
- First submitted
- 8 Apr 2008
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Parallel Group, 10-Week Placebo Controlled Fixed Dose Study Of PD 0332334 And Paroxetine Evaluating The Efficacy And Safety Of PD 0332334 For The Treatment Of Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00658008
- Acronym / sponsor ID
- A5361019
- Conditions
- Generalized Anxiety Disorder
- Keywords
- PD 0332334 phase 3 pivotal trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Please see Detailed Description for termination reason.
- Enrolment
- 501 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Apr 2008 (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.
This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages from 18 to 65, with generalized anxiety disorder.
Detailed description
Termination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
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 |
|---|---|---|
| PD 0332334 175 mg BID | Experimental | Drug: PD 0332334 |
| PD 0332334 225 mg BID | Experimental | Drug: PD 0332334 |
| PD 0332334 75 mg BID | Experimental | Drug: PD 0332334 |
| Paroxetine 20 mg QD | Active comparator | Drug: Paroxetine |
| Placebo BID | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of GAD (Diagnostic and Statistical Manual IV [DSM IV], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM IV) or dysthymic disorder will be allowed in the study.
- Subjects must have a HAM A total score ≥20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of ≥9 and a Raskin Depression Scale score ≤7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.
Key exclusion criteria (5 listed)
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
- Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnosis: Major Depressive Disorder, Obsessive Compulsive Disorder, Panic Disorder, Agoraphobia, Posttraumatic Stress Disorder, Anorexia, Bulimia, Caffeine induced anxiety disorder, Alcohol or substance abuse or dependence unless in full remission for at least 6 months, Social Anxiety Disorder.
- Any of the following past or current DSM-IV Axis I diagnoses: Schizophrenia, Psychotic disorder, Delirium, dementia, amnestic, and other clinically significant cognitive disorders, Bipolar or schizoaffective disorder, Cyclothymic disorder, Dissociative disorders.
- Antisocial or borderline personality disorder.
- Serious suicidal risk per the clinical investigator's judgment.
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 |
|---|---|---|
| PD 0332334Also: imagabalinCapsules, oral, 175 mg BID, 8 weeks with 2 week taper | Drug | PD 0332334 175 mg BID |
| PD 0332334Capsules, oral, 225 mg BID, 8 weeks with 2 week taper | Drug | PD 0332334 225 mg BID |
| PD 0332334Capsules, oral, 75 mg BID, 8 weeks with 2 week taper | Drug | PD 0332334 75 mg BID |
| ParoxetineCapsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper | Drug | Paroxetine 20 mg QD |
| PlaceboCapsules, oral, placebo bid, 8 weeks with 2 week taper | Drug | Placebo BID |
Primary outcome
The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment.
Time frame: 8 weeks
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study
Time frame: 8 weeks
20 secondary outcomes
Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)
Time frame: 8 weeks
Response rate on the patient-rated PGI-C at week 8
Time frame: 8 weeks
Change from baseline to week 8 on the Sheehan Disability Scale subscales
Time frame: 8 weeks
Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13)
Time frame: 8 weeks
Response rate on the HAM-A at week 1 and week 8
Time frame: 8 weeks
Response rate on the clinician-rated CGI-I ate week 1 and week 8
Time frame: 8 weeks
Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8
Time frame: 8 weeks
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II
Time frame: 1 week
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II
Time frame: 8 weeks
Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6
Time frame: 6 weeks
Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8
Time frame: 8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales
Time frame: 8 weeks
Remission rate based on the HAM A at Week 8
Time frame: 8 weeks
Change from baseline in CGI-S at week 8
Time frame: 8 weeks
Change from baseline to week 8 in the QLesQ General Activity Score
Time frame: 8 weeks
The "Week 1 Sustained Responder" rate based on the HAM A (where "Week 1 Sustained Responders" are defined as subjects with a 50% or greater improvement from baseline on the HAM A total score at Week 1 that is sustained until the Week 8 visit)
Time frame: 1 week
Change from Baseline to Days 2 8 and Weeks 2, 4, 6, 8 on the DAS A (total score)
Time frame: 8 weeks
Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score
Time frame: 8 weeks
Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary)
Time frame: 8 weeks
Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Please see Detailed Description for termination reason.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 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
52 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PD 0332334 and Paroxetine in people with Generalized Anxiety Disorder, run by Pfizer at 52 sites in 5 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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Hungary, Italy, South Korea, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Please see Detailed Description for termination reason.). Results are not available in the source record.
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?
The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment. (time frame: 8 weeks). The study lists 2 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 16 Nov 2012.