Nonrestorative SleepPhase 2NCT00655369
A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep
A Phase 2 study testing PD 0200390 in people with Nonrestorative Sleep, run by Pfizer at 59 sites in 2 countries.
Trial summary
In a Phase II trial in subjects with nonrestorative sleep, PD 0200390 demonstrated a positive treatment effect relative to placebo on the primary endpoint, the weekly version of the Restorative Sleep Questionnaire (RSQ-W). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Nonrestorative Sleep
- 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
- 306 participants
- Where
- 59 sitesin 2 countries
- Study dates
- Apr 2008to Dec 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
- Awake unrestored or unrefreshed, associated with significant distress or impairment in social, occupational, or other important areas of functioning during the daytime, for at least 3 nights for the past 3 months prior to screening
- Self-report wake after sleep onset <45 mins for past 3 mos; self-report latency to sleep onset <20 mins for past 3 mos
- PSG (Polysomnography) sleep criteria of wake after sleep onset < 45 mins; Latency to persistent sleep <20 mins.
Who cannot join
- MAP (Multivariable Apnea Risk index) index > or = 0.5 at screening
- BMI = or > 32 kg/m2
- History or presence of breathing related disorders
- PSG findings consistent with and periodic limb movement disorder, narcolepsy or other dyssomnia or parasomnia including apnea-hypopnea index > 10/hr; or period limb movement with arousal index > 10/hr.
Trial locations and contacts
59 sites in 2 countries.
59 sites in 2 countries
United States52 sites
Pfizer Investigational Site
Atlanta, Georgia, 30328
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Austin, Texas, 78756
Pfizer Investigational Site
Baton Rouge, Louisiana, 70809
Pfizer Investigational Site
Brighton, Massachusetts, 02135
Pfizer Investigational Site
Cary, North Carolina, 27511
Pfizer Investigational Site
Chesterfield, Missouri, 63017
Pfizer Investigational Site
Chevy Chase, Maryland, 20815
Pfizer Investigational Site
Chicago, Illinois, 60634
Pfizer Investigational Site
Cincinnati, Ohio, 45227
Pfizer Investigational Site
Clarks Summit, Pennsylvania, 18411
Pfizer Investigational Site
Columbia, South Carolina, 29201
Pfizer Investigational Site
Crestview Hills, Kentucky, 41017
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Gainesville, Georgia, 30501
Pfizer Investigational Site
Glendale, Arizona, 85306
Pfizer Investigational Site
Indianapolis, Indiana, 46260
Pfizer Investigational Site
Irving, Texas, 75039
Pfizer Investigational Site
Las Vegas, Nevada, 89104
Pfizer Investigational Site
Las Vegas, Nevada, 89146
Pfizer Investigational Site
Lexington, Kentucky, 40504
Pfizer Investigational Site
Lexington, Kentucky, 40513
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Los Angeles, California, 90048
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
Naples, Florida, 34110
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747
Pfizer Investigational Site
North Haven, Connecticut, 06473
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112
Pfizer Investigational Site
Orange City, Florida, 32763
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
Pasadena, California, 91106
Pfizer Investigational Site
Pembroke Pines, Florida, 33026
Pfizer Investigational Site
Phoenix, Arizona, 85306
Pfizer Investigational Site
Raleigh, North Carolina, 27607-6520
Pfizer Investigational Site
Raleigh, North Carolina, 27612
Pfizer Investigational Site
Salisbury, North Carolina, 28144
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Francisco, California, 94105
Pfizer Investigational Site
South Miami, Florida, 33143
Pfizer Investigational Site
St Louis, Missouri, 63108
Pfizer Investigational Site
Tucson, Arizona, 85712
Pfizer Investigational Site
Tustin, California, 92780
Pfizer Investigational Site
Uniontown, Pennsylvania, 15401
Pfizer Investigational Site
Wallingford, Connecticut, 06492
Pfizer Investigational Site
Warwick, Rhode Island, 02886
Pfizer Investigational Site
West Seneca, New York, 14224
Pfizer Investigational Site
West Warwick, Rhode Island, 02893
Pfizer Investigational Site
Wheat Ridge, Colorado, 80033
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Canada7 sites
Pfizer Investigational Site
Etobicoke, Ontario, M9W 6V1
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 3G8
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 4R9
Pfizer Investigational Site
Kitchener, Ontario, N2G 1G1
Pfizer Investigational Site
Parry Sound, Ontario, P2A 3A4
Pfizer Investigational Site
Toronto, Ontario, M4P 1P2
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 Nonrestorative Sleep
In a Phase II trial in subjects with nonrestorative sleep, PD 0200390 demonstrated a positive treatment effect relative to placebo on the primary endpoint, the weekly version of the Restorative Sleep Questionnaire (RSQ-W). In this study, the dose-response relationship of varying doses of PD 0200390 using the Restorative Sleep Questionnaire (RSQ-W), will be explored in Nonrestorative Sleep subjects.
- Conditions
- Nonrestorative Sleep
- Being tested
- PD 0200390, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD 0200390Drug
oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.
PD 0200390Drug
oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.
PD 0200390Drug
oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.
PD 0200390Drug
oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.
PD 0200390Drug
oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.
PlaceboDrug
oral placebo daily dose, 3 capsules per dose during a six week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| 15 mg | Experimental | Not described Receives: Drug: PD 0200390 |
| 25 mg | Experimental | Not described Receives: Drug: PD 0200390 |
| 35 mg | Experimental | Not described Receives: Drug: PD 0200390 |
| 5 mg | Experimental | Not described Receives: Drug: PD 0200390 |
| 50 mg | Experimental | Not described Receives: Drug: PD 0200390 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score of how an individual rates the restorative value of his/her sleep in the morning using the weekly version of the Restorative Sleep Questionnaire (RSQ-Weekly)
Measured: Weekly
Secondary outcomes (9)
Measure sleep and early morning behavior during treatment using the Leeds Sleep Evaluation Questionnaire
Measured: Weeky
Total score of the Daily Restorative Sleep Questionnaire
Measured: Daily
Total score of the Multidimensional Assessment of Fatigue (MAF)
Measured: Weekly
Total score of the Sheehan Disability Scale to measure functional impairment
Measured: Weekly
Measure of health status using the Medical Outcomes Study Short Form-36 (SF-36v2-Acute)
Measured: Weekly
Total mood disturbance score using the Profile of Mood State-Short Form Questionnaire (POMS-SF)
Measured: Weekly
Total score of the Endicott Work Productivity Scale (EWPS) measuring work productivity.
Measured: Weekly
Disease severity and change using the Clinical Global Impression of Severity (CGI-S) as rated by the Clinician.
Measured: Weekly
Disease change (patient rated) measure using the Patient Global Impression of Change (PGIC).
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonrestorative SleepStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 306 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
- NCT00655369
- Sponsor's protocol ID
- A4251033
- Status last verified
- Jul 2012
- First submitted
- 3 Apr 2008
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Drake CL, Hays RD, Morlock R, Wang F, Shikiar R, Frank L, Downey R, Roth T. Development and evaluation of a measure to assess restorative sleep. J Clin Sleep Med. 2014 Jul 15;10(7):733-41, 741A-741E. doi: 10.5664/jcsm.3860.
PubMed 25024650
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 Nonrestorative Sleep
- ClinicalTrials.gov ID
- NCT00655369
- Acronym / sponsor ID
- A4251033
- Conditions
- Nonrestorative Sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Apr 2008 (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.
In a Phase II trial in subjects with nonrestorative sleep, PD 0200390 demonstrated a positive treatment effect relative to placebo on the primary endpoint, the weekly version of the Restorative Sleep Questionnaire (RSQ-W). In this study, the dose-response relationship of varying doses of PD 0200390 using the Restorative Sleep Questionnaire (RSQ-W), will be explored in Nonrestorative Sleep subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 15 mg | Experimental | Drug: PD 0200390 |
| 25 mg | Experimental | Drug: PD 0200390 |
| 35 mg | Experimental | Drug: PD 0200390 |
| 5 mg | Experimental | Drug: PD 0200390 |
| 50 mg | Experimental | Drug: PD 0200390 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Awake unrestored or unrefreshed, associated with significant distress or impairment in social, occupational, or other important areas of functioning during the daytime, for at least 3 nights for the past 3 months prior to screening
- Self-report wake after sleep onset <45 mins for past 3 mos; self-report latency to sleep onset <20 mins for past 3 mos
- PSG (Polysomnography) sleep criteria of wake after sleep onset < 45 mins; Latency to persistent sleep <20 mins.
Key exclusion criteria (4 listed)
- MAP (Multivariable Apnea Risk index) index > or = 0.5 at screening
- BMI = or > 32 kg/m2
- History or presence of breathing related disorders
- PSG findings consistent with and periodic limb movement disorder, narcolepsy or other dyssomnia or parasomnia including apnea-hypopnea index > 10/hr; or period limb movement with arousal index > 10/hr.
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 daily dose, 3 capsules per dose during a six week treatment period. | Drug | 15 mg |
| PD 0200390oral 25 mg daily dose, 3 capsules per dose during a six week treatment period. | Drug | 25 mg |
| PD 0200390oral 35 mg daily dose, 3 capsules per dose during a six week treatment period. | Drug | 35 mg |
| PD 0200390oral 5 mg daily dose, 3 capsules per dose during a six week treatment period. | Drug | 5 mg |
| PD 0200390oral 50 mg daily dose, 3 capsules per dose during a six week treatment period. | Drug | 50 mg |
| Placebooral placebo daily dose, 3 capsules per dose during a six week treatment period. | Drug | Placebo |
Primary outcome
Total score of how an individual rates the restorative value of his/her sleep in the morning using the weekly version of the Restorative Sleep Questionnaire (RSQ-Weekly)
Time frame: Weekly
9 secondary outcomes
Measure sleep and early morning behavior during treatment using the Leeds Sleep Evaluation Questionnaire
Time frame: Weeky
Total score of the Daily Restorative Sleep Questionnaire
Time frame: Daily
Total score of the Multidimensional Assessment of Fatigue (MAF)
Time frame: Weekly
Total score of the Sheehan Disability Scale to measure functional impairment
Time frame: Weekly
Measure of health status using the Medical Outcomes Study Short Form-36 (SF-36v2-Acute)
Time frame: Weekly
Total mood disturbance score using the Profile of Mood State-Short Form Questionnaire (POMS-SF)
Time frame: Weekly
Total score of the Endicott Work Productivity Scale (EWPS) measuring work productivity.
Time frame: Weekly
Disease severity and change using the Clinical Global Impression of Severity (CGI-S) as rated by the Clinician.
Time frame: Weekly
Disease change (patient rated) measure using the Patient Global Impression of Change (PGIC).
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.
- Derived from this study: PubMed 25024650Drake CL, Hays RD, Morlock R, Wang F, Shikiar R, Frank L, Downey R, Roth T. Development and evaluation of a measure to assess restorative sleep. J Clin Sleep Med. 2014 Jul 15;10(7):733-41, 741A-741E. doi: 10.5664/jcsm.3860.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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
59 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 Nonrestorative Sleep, run by Pfizer at 59 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 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 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 59 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. 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?
Total score of how an individual rates the restorative value of his/her sleep in the morning using the weekly version of the Restorative Sleep Questionnaire (RSQ-Weekly) (time frame: Weekly). 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 NCT00655369, 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 25 Jul 2012.