Primary InsomniaPhase 2NCT00551148
A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia
A Phase 2 study testing PD 0200390 in people with Primary Insomnia, run by Pfizer at 16 sites in United States.
Trial summary
The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- PD 0200390
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 16 sitesUnited States
- Study dates
- Oct 2007to Jan 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 3 month history of Primary Insomnia (DSM-IV criteria)
- Self report sleep criteria for at least 3 nights per week in past month;
- sWASO (subjective wake after sleep onset) equal or greater than 60 mins
- sLSO (subjective latency to sleep onset) equal or greater than 45 minutes
- TST less than or equal to 6.5 hrs
- Maintain normal daytime-awake, nighttime-sleep schedule
Show all 9Show fewer
- PSG sleep criteria of mean WASO equal or greater than 60 mins calculated on 2 PSG screening nights
- TST between 3 to 7 hrs on 2 PSG screening nights
- Mean LPS (latency to persistent sleep) equal or greater than 20 mins calculated on 2 PSG screening nights
Who cannot join
- Comorbid psychiatric disease or disorders
- History or presence of breathing-related disorders
- Multivariable Apnea risk index (MAP) equal or greater than 0.5 at screening
- History or presence of medical or neurological condition interfering with sleep
- Current use of know psychotropic effect medications
- Excessive caffeine use
- Use of alcohol as a sleep aid or more than 2 standard drinks/day
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Cary, North Carolina, 27511
Pfizer Investigational Site
Cincinnati, Ohio, 45227
Pfizer Investigational Site
Crestview Hills, Kentucky, 41017
Pfizer Investigational Site
Glendale, Arizona, 85306
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
Naples, Florida, 34110
Pfizer Investigational Site
New York, New York, 10019
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
Phenoix, Arizona, 85006
Pfizer Investigational Site
Phoenix, Arizona, 85006
Pfizer Investigational Site
Raleigh, North Carolina, 27612
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
South Miami, Florida, 33143
Pfizer Investigational Site
Tucson, Arizona, 85712
About this study
Official title: PD 0200390 Dose-ranging Trial: A Randomized, Double-blind, Placebo-controlled, 5-way Crossover, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia
The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.
- Conditions
- Primary Insomnia
- Being tested
- PD 0200390, Placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD 0200390Drug
oral 15 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
PD 0200390Drug
oral 30 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
PD 0200390Drug
oral 5 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
PD 0200390Drug
oral 60 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
PlaceboOther
oral placebo mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| 15 mg | Experimental | Not described Receives: Drug: PD 0200390 |
| 30 mg | Experimental | Not described Receives: Drug: PD 0200390 |
| 5 mg | Experimental | Not described Receives: Drug: PD 0200390 |
| 60 mg | Experimental | Not described Receives: Drug: PD 0200390 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography
Measured: weekly
Secondary outcomes (4)
Subjective assessments of wake after sleep onset (sWASO), latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO), total sleep time (TST), and sleep quality via questionnaire.
Measured: weekly
Subjective assessment of sleep with Leeds Sleep Evaluation Questionnaire-LSEQ.
Measured: weekly
PSG efficacy assessments including number of awakenings after sleep onset (NAASO), number of arousals, total sleep time (TST), sleep efficiency (SE), total wake time (TWT)
Measured: weekly
Latency to persistent sleep (LPS) as determined by Polysomnography
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 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
- NCT00551148
- Sponsor's protocol ID
- A4251068
- Status last verified
- Jul 2012
- First submitted
- 27 Oct 2007
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD 0200390 Dose-ranging Trial: A Randomized, Double-blind, Placebo-controlled, 5-way Crossover, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia
- ClinicalTrials.gov ID
- NCT00551148
- Acronym / sponsor ID
- A4251068
- Conditions
- Primary Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 30 Oct 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 purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 15 mg | Experimental | Drug: PD 0200390 |
| 30 mg | Experimental | Drug: PD 0200390 |
| 5 mg | Experimental | Drug: PD 0200390 |
| 60 mg | Experimental | Drug: PD 0200390 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 3 month history of Primary Insomnia (DSM-IV criteria)
- Self report sleep criteria for at least 3 nights per week in past month;
- sWASO (subjective wake after sleep onset) equal or greater than 60 mins
- sLSO (subjective latency to sleep onset) equal or greater than 45 minutes
- TST less than or equal to 6.5 hrs
Key exclusion criteria (7 listed)
- Comorbid psychiatric disease or disorders
- History or presence of breathing-related disorders
- Multivariable Apnea risk index (MAP) equal or greater than 0.5 at screening
- History or presence of medical or neurological condition interfering with sleep
- Current use of know psychotropic effect medications
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 0200390oral 15 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks. | Drug | 15 mg |
| PD 0200390oral 30 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks. | Drug | 30 mg |
| PD 0200390oral 5 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks. | Drug | 5 mg |
| PD 0200390oral 60 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks. | Drug | 60 mg |
| Placebooral placebo mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks. | Other | Placebo |
Primary outcome
Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography
Time frame: weekly
4 secondary outcomes
Subjective assessments of wake after sleep onset (sWASO), latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO), total sleep time (TST), and sleep quality via questionnaire.
Time frame: weekly
Subjective assessment of sleep with Leeds Sleep Evaluation Questionnaire-LSEQ.
Time frame: weekly
PSG efficacy assessments including number of awakenings after sleep onset (NAASO), number of arousals, total sleep time (TST), sleep efficiency (SE), total wake time (TWT)
Time frame: weekly
Latency to persistent sleep (LPS) as determined by Polysomnography
Time frame: weekly
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 25 Jul 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
16 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 PD 0200390 in people with Primary Insomnia, run by Pfizer at 16 sites in United States.
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 9 inclusion and 7 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 25 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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?
Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography (time frame: weekly). 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 25 Jul 2012.