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Schizophrenic DisordersPhase 3RECOVERNCT00600756

Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone

A Phase 3 study testing Quetiapine XR and Risperidone in people with Schizophrenic Disorders, run by AstraZeneca at 116 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The trial is designed to assess the long term subjective well-being in schizophrenic outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible dose in a naturalistic setting over a period of one year. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenic Disorders
What is being tested?
Quetiapine XR and Risperidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
798 participants
Where
116 sitesin 14 countries
Study dates
Jan 2008to Oct 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Treated for symptomatic schizophrenia (DSM-IV-TR codes: 295.10, 295.20, 295.30,295.60, 295.90) or schizoaffective disorder (DSM-IV-TR code:295.70) or schizophreniform disorder (DSM-IV-TR code: 295.40). Patients with co-morbid depressive symptoms may be enrolled
  • Patient with first episode of the above mentioned disease (item 3) or patient requiring a medication change for clinical reasons (effectiveness, tolerability, compliance, patient preference), i.e. switch from typical to atypical neuroleptics, switch from other atypical neuroleptics, excluding patients treated with risperidone or quetiapine at the time of enrolment.

Who cannot join

  • Patients with a baseline SWN-K total score of >75
  • Patients with previous treatment with risperidone or quetiapine may be enrolled if change of treatment has not been dictated by major lack of tolerability and efficacy and if date of last dose has been at least 3 months prior to enrolment.

Trial locations and contacts

116 sites in 14 countries.

116 sites in 14 countries

Germany20 sites
  • Research Site

    Bad Saarow

  • Research Site

    Berlin

  • Research Site

    Bielefeld

  • Research Site

    Bochum

  • Research Site

    Butzbach

  • Research Site

    Cologne

  • Research Site

    Darmstadt

  • Research Site

    Duisburg

  • Research Site

    Gelsenkirchen

  • Research Site

    Grevenbroich

  • Research Site

    Hamburg

  • Research Site

    Hattingen

  • Research Site

    Hildesheim

  • Research Site

    Königsbrück

  • Research Site

    Mittweida

  • Research Site

    München

  • Research Site

    Oranienburg

  • Research Site

    Siegen

  • Research Site

    Stralsund

  • Research Site

    Wismar

Other trials in Germany

Italy16 sites
  • Research Site

    Ancona

  • Research Site

    Andria, BA

  • Research Site

    Chioggia, VE

  • Research Site

    Feltre, BL

  • Research Site

    Fidenza, PR

  • Research Site

    Genova, GE

  • Research Site

    Maddaloni, CE

  • Research Site

    Milan, MI

  • Research Site

    Palmi, RC

  • Research Site

    Parma, PR

  • Research Site

    Perugia, PG

  • Research Site

    Pompei

  • Research Site

    Rimini, RN

  • Research Site

    Salerno, SA

  • Research Site

    Sassari, SS

  • Research Site

    Sora, FR

Other trials in Italy

Brazil13 sites
  • Research Site

    Aparecida de Goiânia, Goiás

  • Research Site

    Belo Horizonte, Minas Gerais

  • Research Site

    Botucatu

  • Research Site

    Curitiba, Paraná

  • Research Site

    Fortaleza, Ceará

  • Research Site

    Itapira, São Paulo

  • Research Site

    Porto Alegre, Rio Grande do Sul

  • Research Site

    Recife, Pernambuco

  • Research Site

    Ribeirão Preto, São Paulo

  • Research Site

    Rio de Janeiro, Rio de Janeiro

  • Research Site

    Salvador, Estado de Bahia

  • Research Site

    São Paulo, São Paulo

  • Research Site

    Sorocaba, São Paulo

Other trials in Brazil

Spain12 sites
  • Research Site

    Elche (alicante), Valencia

  • Research Site

    Jaén, Andalusia

  • Research Site

    Langreo, Principality of Asturias

  • Research Site

    Madrid, Madrid

  • Research Site

    Málaga, Andalusia

  • Research Site

    Mataro (barcelona), Catalonia

  • Research Site

    Salamanca, Castille and León

  • Research Site

    Sant Joan d'Alacant, Valencia

  • Research Site

    Seville, Andalusia

  • Research Site

    Vigo, Galicia

  • Research Site

    Zamora, Castille and León

  • Research Site

    Zamudio (vizcaya), Basque Country

Other trials in Spain

Finland9 sites
  • Research Site

    Helsinki

  • Research Site

    Kitee

  • Research Site

    Kuopio

  • Research Site

    Lapua

  • Research Site

    Pori

  • Research Site

    Raahe

  • Research Site

    Rovaniemi

  • Research Site

    Tampere

  • Research Site

    Turku

Other trials in Finland

Belgium7 sites
  • Research Site

    Assebroek, Belgium

  • Research Site

    Hasselt, Belgium

  • Research Site

    Liège, Belgium

  • Research Site

    Montignies-sur-Sambre, Belgium

  • Research Site

    Roeselare, Belgium

  • Research Site

    Sint-Denijs-Westrem

  • Research Site

    Tournai

Other trials in Belgium

Bulgaria7 sites
  • Research Site

    Cerova Koria Village, Veliko Tarnovo

  • Research Site

    Pazardzhik

  • Research Site

    Pleven

  • Research Site

    Plovdiv

  • Research Site

    Sofia

  • Research Site

    Stara Zagora

  • Research Site

    Varna

Other trials in Bulgaria

Mexico7 sites
  • Research Site

    Guadalajara Jalisco

  • Research Site

    México, D.f.

  • Research Site

    México, D.F

  • Research Site

    México

  • Research Site

    Monterrey, Nuevo Leon, Mexico

  • Research Site

    San Luis Potosí City, San Luis Potosí

  • Research Site

    Yucatán

Other trials in Mexico

Portugal6 sites
  • Research Site

    Abraveses

  • Research Site

    Braga

  • Research Site

    Coimbra

  • Research Site

    Lisbon

  • Research Site

    Porto

  • Research Site

    Santarém

Other trials in Portugal

Romania5 sites
  • Research Site

    Bucharest

  • Research Site

    Craiova

  • Research Site

    Galati, Galați County

  • Research Site

    Piteşti, Argeş

  • Research Site

    Sibiu

Other trials in Romania

Turkey (Türkiye)5 sites
  • Research Site

    Ankara

  • Research Site

    Elâzığ

  • Research Site

    Istanbul, Turkey

  • Research Site

    Izmir

  • Research Site

    Manisa, Turkey

Other trials in Turkey (Türkiye)

Russia4 sites
  • Research Site

    Kazan'

  • Research Site

    Moscow, Russia

  • Research Site

    Moscow

  • Research Site

    Saint Petersburg

Other trials in Russia

Costa Rica3 sites
  • Research Site

    Barrio Los Yoses, Provincia de San José

  • Research Site

    Curridabat, Provincia de San José

  • Research Site

    Guadalupe, Provincia de San José

Other trials in Costa Rica

Switzerland2 sites
  • Research Site

    Prilly, Canton of Vaud

  • Research Site

    Wil

Other trials in Switzerland

About this study

Official title: A One-Year Randomized, Prospective, Parallel, Open Comparison of Subjective Well-being in Schizophrenic Out-patients Treated With Quetiapine XR (SEROQUEL XR™) or Oral Risperidone at Flexible Dose in a Naturalistic Setting

The trial is designed to assess the long term subjective well-being in schizophrenic outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible dose in a naturalistic setting over a period of one year. Secondary outcome measures have been selected for helping in the differentiation of the compared atypical antipsychotics. The primary objective of this study is to demonstrate the non-inferiority of quetiapine XR to risperidone assessed at month 6 in terms of responder rate using the self-report instrument SWN-K

Being tested
Quetiapine XR, Risperidone
Keywords
schizophrenia, SWNK
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quetiapine XRDrug

    Also called Seroquel XR

    Oral, once daily, tablets of 400 mg to 800 mg

  • RisperidoneDrug

    Also called Risperdal

    Oral, once daily, tablets of 2 mg to 6 mg

Study groups in NCT00600756
Study groupRoleWhat they receive
Quetiapine XRExperimentalNot described
Receives: Drug: Quetiapine XR
RisperidoneActive comparatorNot described
Receives: Drug: Risperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score

    The SWN-K is comprised of 20 questions, rated on a 6-point scale from 1 (not at all) to 6 (very much). Scores range from 20 to 120, with higher scores implying higher subjective well-being. A responder is defined as a subject with an increase of 10 points or 20% from baseline in SWN-K total score (non-inferiority limit of -9.7% in responder rate)

    Measured: 6 months

Secondary outcomes (30)
  1. Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population

    The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.

    Measured: Baseline and Month 12

  2. Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Intent-to-Treat (ITT) Population

    The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.

    Measured: Baseline and Month 12

  3. Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Physical Functioning at Month 12 in the ITT Population.

    The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.

    Measured: Baseline and 12 months

  4. Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Social Integration at Month 12 in the ITT Population.

    The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.

    Measured: Baseline and 12 months

  5. Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Mental Functioning at Month 12 in the ITT Population.

    The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.

    Measured: Baseline and 12 months

  6. Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Self-control at Month 12 in the ITT Population.

    The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.

    Measured: Baseline and 12 months

  7. Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Emotional Regulation at Month 12 in the ITT Population.

    The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.

    Measured: Baseline and 12 months

  8. The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population

    Remission was defined as a SWN-K total score greater than or equal to 80. The reported population is participants who showed remission over, time from baseline to Month 12

    Measured: 12 months

  9. The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score (Improved).

    For the CGI-SCH overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0). Change from baseline in CGI-SCH overall severity of illness in number of participants with CGI-SCH overall severity score improvement.

    Measured: 12 months

  10. The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score

    For the CGI-SCH (Clinical Global Impression-Schizophrenia severity of illness scale) overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). Change from baseline in CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0).

    Measured: 12 months

  11. The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) Total Score

    The CDSS total score is the sum of 9 questions and ranges from 0 to 27. The higher the score, the more severe are the symptoms.

    Measured: 12 months

  12. The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population

    Relapse is defined as at least one increase of greater than or equal to 2 points on the CGI-SCH overall severity score during the treatment period or at least one hospitalization due to psychiatric disorders during the treatment period.

    Measured: 12 months

  13. Evaluation of Effect of Quetiapine XR Versus Risperidone on the Health-related Quality of Life of Patients With Schizophrenia by Evaluating the Change From Baseline in EQ-5D(Euro Quality of Life-5 Dimension) Index Score at Month 12 in the ITT Population.

    The Euro Quality of Life - 5 dimension index (EQ-5D) is the result of the application of a formula that essentially attaches values (also called weights) to each of the levels (no, some, or heavy problems) in each dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). These weights are issued from a representative sample of the general population. The total possible maximum value was 1 (healthy life) and the minimum value was 0 (death).

    Measured: 12 months

  14. To Evaluate the Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population Regarding Health Economics Outcomes by Evaluating the Functional Improvement Rate of the Modified Vocational Status Index/ Location Code Index: Stable State

    Stable State was defined as having the same status in occupational and residential status as at Baseline.

    Measured: 12 months

  15. The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Mean Number of Lost School/Work Days at Month 12 in the ITT Population

    Workers and students are defined from the modified vocational status index excluding subjects "Retired" or "Unemployed, whether or not expected to work".

    Measured: 12 months

  16. The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Participants With at Least 1 Hospitalization Due to Psychiatric Disorders at Month 12 in the ITT Population

    All hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards, and in day clinics.

    Measured: 12 months

  17. Number of Subjects Who Had an Unscheduled Visits Due to Worsening of Schizophrenia, Dose Change, or Adverse Event at Month 12 in the ITT Population

    Unscheduled visits due to worsening of schizophrenia, dose change or adverse event including the hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards and in day clinics.

    Measured: Month 12

  18. The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Time Between First Study Drug Intake and First Hospitalization for Patients With 1 Hospitalization in the ITT Population

    Measured: 12 months

  19. Number of Participants Using Antidepressants at Month 12 in the ITT Population

    The number of participants who were taking at least 1 antidepressant at Month 12. Antidepressants are all concomitant medications classified in the Anatomical Therapeutic Chemical(ATC)Subgroup "N06-Antidepressants".

    Measured: 12 months

  20. The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Number of Participants Using Other Psychotropic Medications at Month 12 in the ITT Population

    Other psychotropic medications include antiepileptics, anti-parkinson drugs, antipsychotics, and antidepressants.

    Measured: 12 months

  21. The Compliance of Patients Taking Quetiapine XR Versus Risperidone at Month 12 by Evaluating the Number of Participants Who Returned Study Drug at Month 12 in the ITT Population

    Measured: 12 months

  22. The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants With a Treatment-emergent Adverse Event (TEAEs) at Month 12 in the Safety Population

    Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).

    Measured: 12 months

  23. The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Discontinued the Study Because of an TEAE at Month 12 in the Safety Population

    Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).

    Measured: 12 months

  24. The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Extra-pyramidal TEAE at Month 12 in the Safety Population

    Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).

    Measured: 12 months

  25. The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Extra-pyramidal Events at Month 12 in the Safety Population

    Extra-pyramidal events include tremor, hypokinesia, muscle rigidity, hyperkinesia, and extrapyramidal disorder.

    Measured: 12 months

  26. The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Cardiac TEAE at Month 12 in the Safety Population

    Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).

    Measured: 12 months

  27. The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Mean Change From Baseline to Month 12 in Prolactin Levels in the Safety Population

    The normal range for men is 0 to 14, and for women is 0 to 24.

    Measured: 12 months

  28. The Safety and Tolerability of Quetiapine XR vs Risperidone by Evaluating the Number of Participants at Month 12 in Safety Population With Individual Symptoms Assessed by the Modified Udvalg for Kliniske Undersogelser, Side Effect Rating Scale: Neurologic

    Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). An individual AE is defined as an AE with a worse degree compared with Baseline and with a possible or probable relationship to study drug.

    Measured: 12 months

  29. The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Hyperprolactinaemia in Women

    Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Hyperprolactinaemia in women is defined as number of women who show the individual adverse event (AE) hyperprolactinaemia. An individual AE Hyperprolactinaemia is defined as an AE with a worse degree of hyperprolactinaemia compared with baseline and with a possible or probable relationship to study drug.

    Measured: Month 12

  30. The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Sexual Dysfunction in Men

    Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Sexual dysfunction in men is defined as number of men who show the individual adverse event (AE) sexual dysfunction. An individual AE sexual dysfunction is defined as an AE with a worse degree of sexual dysfunction compared with baseline and with a possible or probable relationship to study drug.

    Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

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
None (open label)
Enrolment
798 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00600756
Sponsor's protocol ID
D1443L00039
Acronym
RECOVER
Status last verified
Oct 2012
First submitted
9 Jan 2008
Last updated
5 Oct 2012

Publications

  • Naber D, Peuskens J, Schwarzmann N, Goltz M, Kruger H, Lambert M, Haro JM. Subjective well-being in schizophrenia: a randomised controlled open-label 12-month non-inferiority study comparing quetiapine XR with risperidone (RECOVER). Eur Neuropsychopharmacol. 2013 Oct;23(10):1257-69. doi: 10.1016/j.euroneuro.2013.07.006. Epub 2013 Jul 29.

    PubMed 23953270

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quetiapine XR and Risperidone in people with Schizophrenic Disorders, run by AstraZeneca at 116 sites in 14 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 2 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 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in Germany, Italy, Brazil, Spain, Finland and 9 more countries. 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?

Yes. Results are posted in the registry (first posted 12 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00600756, which also lists 1 linked publication.

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 5 Oct 2012.

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