InsomniaPhase 2NCT00569972
A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
A Phase 2 study testing PD 0200390 in people with Insomnia, run by Pfizer at 84 sites in 2 countries.
Trial summary
To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- 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
- 682 participants
- Where
- 84 sitesin 2 countries
- Study dates
- Oct 2007to Jan 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- 3 month history of primary insomnia;
- 18 to 64 years
- For the last 3 months-regularly awake unrefreshed and unrestored
- Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)
Who cannot join
- Any history of an Axis 1 psychiatric diagnosis;
- History or presence of any breathing related sleep disorder;
- History or presence of any medical or neurological condition that could interfere with sleep
- Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week
Trial locations and contacts
84 sites in 2 countries.
84 sites in 2 countries
United States71 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87108
Pfizer Investigational Site
Ann Arbor, Michigan, 48104
Pfizer Investigational Site
Arlington Heights, Illinois, 60004
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Austin, Texas, 78754
Pfizer Investigational Site
Austin, Texas, 78756
Pfizer Investigational Site
Birmingham, Alabama, 35213
Pfizer Investigational Site
Brooksville, Florida, 34613
Pfizer Investigational Site
Charleston, South Carolina, 29407
Pfizer Investigational Site
Charlotte, North Carolina, 28207
Pfizer Investigational Site
Chevy Chase, Maryland, 20815
Pfizer Investigational Site
Chicago, Illinois, 60607
Pfizer Investigational Site
Chicago, Illinois, 60622
Pfizer Investigational Site
Cincinnati, Ohio, 45245
Pfizer Investigational Site
Cleveland, Ohio, 44122
Pfizer Investigational Site
Colorado Springs, Colorado, 80909
Pfizer Investigational Site
Columbus, Ohio, 43213
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dayton, Ohio, 45408
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
East Providence, Rhode Island, 02914
Pfizer Investigational Site
Encino, California, 91316
Pfizer Investigational Site
Evansville, Indiana, 47714
Pfizer Investigational Site
Gainsville, Georgia, 30501
Pfizer Investigational Site
Garden Grove, California, 92845
Pfizer Investigational Site
Hallandale, Florida, 330009
Pfizer Investigational Site
Hallandale, Florida, 33009
Pfizer Investigational Site
Houston, Texas, 77024
Pfizer Investigational Site
Houston, Texas, 77063
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Jupiter, Florida, 33458
Pfizer Investigational Site
Kalamazoo, Michigan, 49009
Pfizer Investigational Site
Kettering, Ohio, 45429
Pfizer Investigational Site
Lexington, Kentucky, 40504
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Los Alamitos, California, 90720
Pfizer Investigational Site
Macon, Georgia, 31201
Pfizer Investigational Site
Maitland, Florida, 32751
Pfizer Investigational Site
Memphis, Tennessee, 38117
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
Mount Sterling, Kentucky, 40353
Pfizer Investigational Site
Mount Sterlingg, Kentucky, 40353
Pfizer Investigational Site
New York, New York, 10019
Pfizer Investigational Site
Newburgh, Indiana, 47630
Pfizer Investigational Site
Newport Beach, California, 92660
Pfizer Investigational Site
Newport News, Virginia, 23606
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Pembroke Pines, Florida, 33026
Pfizer Investigational Site
Phoenix, Arizona, 85023
Pfizer Investigational Site
Phoenix, Arizona, 85059
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Redlands, California, 92374
Pfizer Investigational Site
Saint Clair Shores, Michigan, 48081
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Diego, California, 92108
Pfizer Investigational Site
San Diego, California, 92120
Pfizer Investigational Site
Scottsdale, Arizona, 85254
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Sherman Oaks, California, 91403
Pfizer Investigational Site
Spring Hill, Florida, 34609
Pfizer Investigational Site
Staten Island, New York, 10312
Pfizer Investigational Site
Tampa, Florida, 33609-4052
Pfizer Investigational Site
Tampa, Florida, 33609
Pfizer Investigational Site
Tampa, Florida, 33613
Pfizer Investigational Site
Tampa, Florida, 33614
Pfizer Investigational Site
Toledo, Ohio, 43623
Pfizer Investigational Site
Tucson, Arizona, 85712
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Canada13 sites
Pfizer Investigational Site
Brampton, Ontario, L6Y 2R2
Pfizer Investigational Site
Calgary, Alberta, T2X 2A8
Pfizer Investigational Site
Etobicoke, Ontario, M9W 6V1
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 2H4
Pfizer Investigational Site
Kitchener, Ontario, N2G 1G1
Pfizer Investigational Site
Mississauga, Ontario, L5B 4M4
Pfizer Investigational Site
Newmarket, Ontario, L3Y 5G8
Pfizer Investigational Site
Parry Sound, Ontario, P2A 3A4
Pfizer Investigational Site
Sydney, Nova Scotia, B1P 1C6
Pfizer Investigational Site
Toronto, Ontario, M3K 2A7
Pfizer Investigational Site
Toronto, Ontario, M4P 1P2
Pfizer Investigational Site
Toronto, Ontario, M5T 3A9
Pfizer Investigational Site
Toronto, Ontario, M6J 3S3
About this study
Official title: PD 0200390 Dose Ranging Trial: A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.
- Conditions
- 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
Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
PD 0200390Drug
Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
PD 0200390Drug
Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
PD 0200390Drug
Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
PlaceboDrug
Matched oral placebo for weeks 2-7.
| Study group | Role | What they receive |
|---|---|---|
| 15 mg PD 0200390 | Experimental | Not described Receives: Drug: PD 0200390 |
| 30 mg PD 0200390 | Experimental | Not described Receives: Drug: PD 0200390 |
| 45 mg PD 0200390 | Experimental | Not described Receives: Drug: PD 0200390 |
| 60 mg PD 0200390 | Experimental | Not described Receives: Drug: PD 0200390 |
| Placebo PD 0200390 | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.
Measured: Weekly
Secondary outcomes (5)
To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia.
Measured: Weekly
To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia.
Measured: Weekly
To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia.
Measured: Weekly
To characterize the dose response relationship of PD 0200390 on subjective assessments of latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO) and total sleep time (sTST) in subjects with primary insomnia.
Measured: Weekly
To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia.
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 682 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
- NCT00569972
- Sponsor's protocol ID
- A4251037
- Status last verified
- Jul 2012
- First submitted
- 6 Dec 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, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
- ClinicalTrials.gov ID
- NCT00569972
- Acronym / sponsor ID
- A4251037
- Conditions
- Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 Dec 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.
To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 15 mg PD 0200390 | Experimental | Drug: PD 0200390 |
| 30 mg PD 0200390 | Experimental | Drug: PD 0200390 |
| 45 mg PD 0200390 | Experimental | Drug: PD 0200390 |
| 60 mg PD 0200390 | Experimental | Drug: PD 0200390 |
| Placebo PD 0200390 | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 3 month history of primary insomnia;
- 18 to 64 years
- For the last 3 months-regularly awake unrefreshed and unrestored
- Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)
Key exclusion criteria (4 listed)
- Any history of an Axis 1 psychiatric diagnosis;
- History or presence of any breathing related sleep disorder;
- History or presence of any medical or neurological condition that could interfere with sleep
- Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week
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 0200390Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days | Drug | 15 mg PD 0200390 |
| PD 0200390Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days | Drug | 30 mg PD 0200390 |
| PD 0200390Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days | Drug | 45 mg PD 0200390 |
| PD 0200390Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days | Drug | 60 mg PD 0200390 |
| PlaceboMatched oral placebo for weeks 2-7. | Drug | Placebo PD 0200390 |
Primary outcome
To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.
Time frame: Weekly
5 secondary outcomes
To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia.
Time frame: Weekly
To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia.
Time frame: Weekly
To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia.
Time frame: Weekly
To characterize the dose response relationship of PD 0200390 on subjective assessments of latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO) and total sleep time (sTST) in subjects with primary insomnia.
Time frame: Weekly
To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia.
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.
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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
84 sites in 2 countries: 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 Insomnia, run by Pfizer at 84 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 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 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 84 sites in United States, Canada. 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 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?
To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia. (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.