Sleep DisordersPhase 2NCT00992160
Vestipitant 28-day Tolerance Study
A Phase 2 study testing GW597599 in people with Sleep Disorders, run by GlaxoSmithKline at 13 sites in Germany.
Trial summary
This study is a 28-day polysomnographic and subjective assessment of oral Vestipitant 15mg/day for treatment of Primary Insomnia in adults outpatients. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- GW597599
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 13 sitesGermany
- Study dates
- May 2009to Sep 2009
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female aged 18-64 years inclusively with Diagnosis of Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders -Text Revision (DSM-IV-TR) criteria 307.42
- PSG variables collected during 2consecutive PSG screening nights falling as follows: TST between 240-420 mins inclusive (both nights) - LPS (Latency to Persistent Sleep): mean not less than 20mins, each night not less than 15 mins - WASO (Wake After Sleep Onset): mean not less than 60mins, each night not less than 45mins
- Women: non child bearing potential or if child bearing potential agree on Contraceptive Methods listed in Protocol
Who cannot join
- clinically significant Psychiatric and neurological disorders (sleep disorders other than Primary Insomnia, history of alcohol orother substance abuse or dependnce);
- nightshift or rotating shift-work;
- Lifestyle habits in agreement with Protocol requirement: caffeine - alcohol intake and smoke
- healthy according to GSK criteria - laboratory and ECG limits set in the Protocol
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
GSK Investigational Site
Berlin, State of Berlin, 10115
GSK Investigational Site
Berlin, State of Berlin, 10117
GSK Investigational Site
Berlin, State of Berlin, 10629
GSK Investigational Site
Berlin, State of Berlin, 10787
GSK Investigational Site
Berlin, State of Berlin, 13125
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20246
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20253
GSK Investigational Site
Hanover, Lower Saxony, 30159
GSK Investigational Site
Kassel, Hesse, 34131
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19053
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055
About this study
Official title: A 28-Day, Polysomnographic and Subjective Assessment of Vestipitant (15mg/Day) for the Treatment of Primary Insomnia in Adult Outpatients
This study is a 28-day polysomnographic and subjective assessment of oral Vestipitant 15mg/day for treatment of Primary Insomnia in adults outpatients.
- Conditions
- Sleep Disorders
- Being tested
- GW597599, Placebo
- Keywords
- Polysomnography (PSG), Adults, Primary Insomnia
- Medical subject headings
- Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW597599Drug
GW597599 15mg tablet
PlaceboDrug
Placebo to match GW597599 15mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Vestipitant 15mg once daily Receives: Drug: GW597599 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal polysomngraphy
Measured: 6 weeks after start of treatment
Secondary outcomes (2)
Subjective sleep assessments as performed by Post-Sleep Questionnaires and subject -rated Insomnia Severity Index
Measured: 4 weeks after start of treatment
Motor and cognitive functioning assessed by neurological tests (Romberg and Hee-to-toe) and Cognitive tests (Digit Symbol Substitution test and verbal Learning Memory test)
Measured: 4 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 161 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
- NCT00992160
- Sponsor's protocol ID
- 111364
- Status last verified
- Oct 2016
- First submitted
- 16 Jul 2009
- Last updated
- 28 Oct 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 28-Day, Polysomnographic and Subjective Assessment of Vestipitant (15mg/Day) for the Treatment of Primary Insomnia in Adult Outpatients
- ClinicalTrials.gov ID
- NCT00992160
- Acronym / sponsor ID
- 111364
- Conditions
- Sleep Disorders
- Keywords
- Polysomnography (PSG), Adults, Primary Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 9 Oct 2009 (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 a 28-day polysomnographic and subjective assessment of oral Vestipitant 15mg/day for treatment of Primary Insomnia in adults outpatients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: GW597599Vestipitant 15mg once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female aged 18-64 years inclusively with Diagnosis of Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders -Text Revision (DSM-IV-TR) criteria 307.42
- PSG variables collected during 2consecutive PSG screening nights falling as follows: TST between 240-420 mins inclusive (both nights) - LPS (Latency to Persistent Sleep): mean not less than 20mins, each night not less than 15 mins - WASO (Wake After Sleep Onset): mean not less than 60mins, each night not less than 45mins
- Women: non child bearing potential or if child bearing potential agree on Contraceptive Methods listed in Protocol
Key exclusion criteria (4 listed)
- clinically significant Psychiatric and neurological disorders (sleep disorders other than Primary Insomnia, history of alcohol orother substance abuse or dependnce);
- nightshift or rotating shift-work;
- Lifestyle habits in agreement with Protocol requirement: caffeine - alcohol intake and smoke
- healthy according to GSK criteria - laboratory and ECG limits set in the Protocol
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 |
|---|---|---|
| GW597599GW597599 15mg tablet | Drug | Active |
| PlaceboPlacebo to match GW597599 15mg tablet | Drug | Placebo |
Primary outcome
Nocturnal polysomngraphy
Time frame: 6 weeks after start of treatment
2 secondary outcomes
Subjective sleep assessments as performed by Post-Sleep Questionnaires and subject -rated Insomnia Severity Index
Time frame: 4 weeks after start of treatment
Motor and cognitive functioning assessed by neurological tests (Romberg and Hee-to-toe) and Cognitive tests (Digit Symbol Substitution test and verbal Learning Memory test)
Time frame: 4 weeks after start of treatment
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 28 Oct 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW597599 in people with Sleep Disorders, run by GlaxoSmithKline at 13 sites in Germany.
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 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany. 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?
Nocturnal polysomngraphy (time frame: 6 weeks after start of treatment). 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 28 Oct 2016.