Social PhobiaPhase 3SADNCT00264654
Long-term Study Of Paroxetine in Women and Men
A Phase 3 study testing BRL29060A and paroxetine hydrochloride hydrate in people with Social Phobia, run by GlaxoSmithKline at 3 sites in 2 countries.
Trial summary
This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD) Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Social Phobia
- What is being tested?
- BRL29060A and paroxetine hydrochloride hydrate
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2005to Nov 2005
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder) according to DSM-IV-TR criteria.
- Must give a written informed consent.
- If the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
- Patients have a minimum score of 60 on the LSAS total score.
Who cannot join
- Patients primarily diagnosed with a disorder that is categorized into Axis I excluding SAD by DSM-IV-TR (e.g. major depression, dysthymic disorder, specific phobia (simple phobia) , obsessive compulsive disorder, panic disorder) within 24 weeks before week -2.
- Patients with a history or complication of schizophrenia and bipolar disorder
- Patients with a complication of body dysmorphic disorder.
- Patients with evidence of substance abuse (alcohol or drugs).
- substance dependence by DSM-IV-TR criteria within 24 weeks before week -2.
- Patients who started psychotherapy and cognitive-behavioural therapy within 24 weeks before week-2, except for supportive psychotherapy.
Show all 11Show fewer
- Patients receiving electro-convulsive therapy (ECT) within 12 weeks before week -2.
- Patients being pregnant, lactating or are of childbearing potential and are likely to become pregnant.
- Patients with 3 or more points of HAM-D Item No. 3, or who are likely to attempt suicide.
- Patients with a history or complication of cancer or malignant tumor.
- Patients receiving MAO inhibitors (FP®) within 14 days before expected week 0 visit date.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Japan2 sites
GSK Investigational Site
Saitama, 332-0012
GSK Investigational Site
Tokyo, 194-0022
Location not given1 site
GSK Investigational Site
About this study
Official title: Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Open-Label, Uncontrolled, Long-term Study- <Phase III Study>
This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD)
- Conditions
- Social Phobia
- Being tested
- BRL29060A, paroxetine hydrochloride hydrate
- Keywords
- Social, (SAD), Anxiety, Disorder
- Medical subject headings
- Phobia, Social, Anxiety Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRL29060ADrug
paroxetine hydrochloride hydrateDrug
Also called BRL29060A
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0)
Measured: 52 Weeks
Secondary outcomes (1)
Proportion of patients responding with a CGI Global Improvement Item. Change from baseline in the CGI Severity of Illness score. Change from baseline in the HAM-D total score. Proportion of patients continuing treatment.
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startOct 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social PhobiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264654
- Sponsor's protocol ID
- PIR104777
- Acronym
- SAD
- Status last verified
- May 2012
- First submitted
- 9 Dec 2005
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Open-Label, Uncontrolled, Long-term Study- <Phase III Study>
- ClinicalTrials.gov ID
- NCT00264654
- Acronym / sponsor ID
- SAD / PIR104777
- Conditions
- Social Phobia
- Keywords
- Social, (SAD), Anxiety, Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 13 Dec 2005 (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 study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder) according to DSM-IV-TR criteria.
- Must give a written informed consent.
- If the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
- Patients have a minimum score of 60 on the LSAS total score.
Key exclusion criteria (11 listed)
- Patients primarily diagnosed with a disorder that is categorized into Axis I excluding SAD by DSM-IV-TR (e.g. major depression, dysthymic disorder, specific phobia (simple phobia) , obsessive compulsive disorder, panic disorder) within 24 weeks before week -2.
- Patients with a history or complication of schizophrenia and bipolar disorder
- Patients with a complication of body dysmorphic disorder.
- Patients with evidence of substance abuse (alcohol or drugs).
- substance dependence by DSM-IV-TR criteria within 24 weeks before week -2.
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 |
|---|---|---|
| BRL29060A | Drug | – |
| paroxetine hydrochloride hydrateAlso: BRL29060A | Drug | – |
Primary outcome
Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0)
Time frame: 52 Weeks
1 secondary outcome
Proportion of patients responding with a CGI Global Improvement Item. Change from baseline in the CGI Severity of Illness score. Change from baseline in the HAM-D total score. Proportion of patients continuing treatment.
Time frame: 52 Weeks
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 15 Apr 2013.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BRL29060A and paroxetine hydrochloride hydrate in people with Social Phobia, run by GlaxoSmithKline at 3 sites in 2 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 4 inclusion and 11 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 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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. 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 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?
Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0) (time frame: 52 Weeks). 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 15 Apr 2013.