Sleep DisorderPhase 3NCT01468038
A Double-blind Placebo Controlled Trial of Sentra PM, a Medical Food
A Phase 3 study testing Trazodone, Sentra PM and Sentra PM and Trazodone (CoPack Kit Trazamine) in people with Sleep Disorder, run by Targeted Medical Pharma at 1 site in United States.
Trial summary
This is a double blind placebo controlled study of one hundred and four subjects which will be randomized for treatment with Sentra PM alone, Sentra PM with trazadone, trazadone alone and placebo alone. Twenty -six subjects will be randomly placed in one of the four groups. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Trazodone, Sentra PM and Sentra PM and Trazodone (CoPack Kit Trazamine)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Dec 2008
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females over the age of 18 and below age 65.
- Patients with a history of a sleep disturbance with non-restorative sleep defined by perceived increase in sleep latency or morning/daytime grogginess.
Who cannot join
- Subjects who have previously taken GABAdone, SentraPM or trazadone.
- Subjects who are currently taking tricyclic anti-depressants.
- Any blood chemistry anomalies the investigator finds that may put the patient at risk or invalidate study results.
- Pregnant or lactating females.
- Subjects with implanted pacemakers or other implanted electrical devices
Trial locations and contacts
1 site in 1 country.
United States1 site
Targeted Medical Pharma
Los Angeles, California, 90077
About this study
Official title: Sentra PM (a Medical Food) and Trazadone in the Management of Sleep Disorders
This is a double blind placebo controlled study of one hundred and four subjects which will be randomized for treatment with Sentra PM alone, Sentra PM with trazadone, trazadone alone and placebo alone. Twenty -six subjects will be randomly placed in one of the four groups. Each of the one hundred and four subjects will undergo baseline examination to include a sleep study questionnaires and 24- hour electrocardiographic recording. The one hundred and four subjects will then be randomly placed in one of the four groups.
Read the detailed description
Sentra PM can induce restorative sleep compared to placebo, and as good as a sleep drug (trazadone) in subjects experiencing non-restorative sleep. Sentra PM taken with trazadone works better than either product alone. Twenty-six subjects will be randomized to a two week ingestion of Sentra PM at bedtime, twenty-six subjects will be randomized to a two week ingestion of trazadone at bedtime, twenty-six subjects will be randomized to a two week ingestion of Sentra PM with trazadone at bedtime and twenty -six subjects will be randomized to a two week ingestion of placebo at bedtime. Each morning after ingestion of either active product or placebo, the subject will fill out sleep questionnaires. On the fourteenth day of ingestion, a repeat 24-Hour ECG examination will be performed on all one hundred and four subjects and each subject will give a second blood sample for analysis. On the morning of the 14th day of ingestion the final sleep questionnaires will be completed.
- Conditions
- Sleep Disorder
- Being tested
- Trazodone, Sentra PM, Sentra PM and Trazodone (CoPack Kit Trazamine), Placebo trazodone and placebo Sentra PM
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrazodoneDrug
active trazodone and sentra pm-like placebo
Sentra PMOther
Active Sentra PM and trazodone-like placebo
Sentra PM and Trazodone (CoPack Kit Trazamine)Drug
A CoPack Kit - Trazamine, consisting of the co-administration of Sentra PM and trazodone.
Placebo trazodone and placebo Sentra PMDrug
Trazodone-like placebo and Sentra PM-like placebo co-administered as placebo of Trazamine CoPack Kit.
| Study group | Role | What they receive |
|---|---|---|
| Active trazodone and placebo | Active comparator | trazodone 50mg with Sentra PM-like placebo Receives: Drug: Trazodone |
| placebo and active Sentra PM | Active comparator | Trazodone-like placebo and Sentra PM Receives: Other: Sentra PM |
| Sentra PM and trazodone | Active comparator | Active Sentra PM and active trazodone Receives: Drug: Sentra PM and Trazodone (CoPack Kit Trazamine) |
| placebo trazodone and placebo Sentra PM | Placebo comparator | trazadone-like placebo and Sentra PM-like placebo Receives: Drug: Placebo trazodone and placebo Sentra PM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to fall asleep
Subjects time to fall asleep will be measure by patient response to questionnaires to determine if time improved, stayed the same or worsen.
Measured: 14 days
Secondary outcomes (5)
Quality of Sleep
Measured: 14 days
Morning grogginess
Measured: 14 days
Feelings of depression
Measured: 14 days
Feelings of anxiety
Measured: 14 days
Improvement in parasympathetic activity
Improved parasympathetic activity measured by 24 hour ECG holter moniter.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startApr 2008
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Targeted Medical Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468038
- Sponsor's protocol ID
- SentraPM102
- Status last verified
- Nov 2011
- First submitted
- 5 Nov 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentra PM (a Medical Food) and Trazadone in the Management of Sleep Disorders
- ClinicalTrials.gov ID
- NCT01468038
- Acronym / sponsor ID
- SentraPM102
- Conditions
- Sleep Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Targeted Medical PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Nov 2011 (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 is a double blind placebo controlled study of one hundred and four subjects which will be randomized for treatment with Sentra PM alone, Sentra PM with trazadone, trazadone alone and placebo alone. Twenty -six subjects will be randomly placed in one of the four groups. Each of the one hundred and four subjects will undergo baseline examination to include a sleep study questionnaires and 24- hour electrocardiographic recording. The one hundred and four subjects will then be randomly placed in one of the four groups.
Detailed description
Sentra PM can induce restorative sleep compared to placebo, and as good as a sleep drug (trazadone) in subjects experiencing non-restorative sleep. Sentra PM taken with trazadone works better than either product alone. Twenty-six subjects will be randomized to a two week ingestion of Sentra PM at bedtime, twenty-six subjects will be randomized to a two week ingestion of trazadone at bedtime, twenty-six subjects will be randomized to a two week ingestion of Sentra PM with trazadone at bedtime and twenty -six subjects will be randomized to a two week ingestion of placebo at bedtime. Each morning after ingestion of either active product or placebo, the subject will fill out sleep questionnaires. On the fourteenth day of ingestion, a repeat 24-Hour ECG examination will be performed on all one hundred and four subjects and each subject will give a second blood sample for analysis. On the morning of the 14th day of ingestion the final sleep questionnaires will be completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active trazodone and placebo | Active comparator | Drug: Trazodonetrazodone 50mg with Sentra PM-like placebo |
| placebo and active Sentra PM | Active comparator | Other: Sentra PMTrazodone-like placebo and Sentra PM |
| Sentra PM and trazodone | Active comparator | Drug: Sentra PM and Trazodone (CoPack Kit Trazamine)Active Sentra PM and active trazodone |
| placebo trazodone and placebo Sentra PM | Placebo comparator | Drug: Placebo trazodone and placebo Sentra PMtrazadone-like placebo and Sentra PM-like placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females over the age of 18 and below age 65.
- Patients with a history of a sleep disturbance with non-restorative sleep defined by perceived increase in sleep latency or morning/daytime grogginess.
Key exclusion criteria (5 listed)
- Subjects who have previously taken GABAdone, SentraPM or trazadone.
- Subjects who are currently taking tricyclic anti-depressants.
- Any blood chemistry anomalies the investigator finds that may put the patient at risk or invalidate study results.
- Pregnant or lactating females.
- Subjects with implanted pacemakers or other implanted electrical devices
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 |
|---|---|---|
| Trazodoneactive trazodone and sentra pm-like placebo | Drug | Active trazodone and placebo |
| Sentra PMActive Sentra PM and trazodone-like placebo | Other | placebo and active Sentra PM |
| Sentra PM and Trazodone (CoPack Kit Trazamine)A CoPack Kit - Trazamine, consisting of the co-administration of Sentra PM and trazodone. | Drug | Sentra PM and trazodone |
| Placebo trazodone and placebo Sentra PMTrazodone-like placebo and Sentra PM-like placebo co-administered as placebo of Trazamine CoPack Kit. | Drug | placebo trazodone and placebo Sentra PM |
Primary outcome
Time to fall asleep
Time frame: 14 days
Subjects time to fall asleep will be measure by patient response to questionnaires to determine if time improved, stayed the same or worsen.
5 secondary outcomes
Quality of Sleep
Time frame: 14 days
Morning grogginess
Time frame: 14 days
Feelings of depression
Time frame: 14 days
Feelings of anxiety
Time frame: 14 days
Improvement in parasympathetic activity
Time frame: 14 days
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 9 Nov 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trazodone, Sentra PM and Sentra PM and Trazodone (CoPack Kit Trazamine) in people with Sleep Disorder, run by Targeted Medical Pharma at 1 site 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 2 inclusion and 5 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 9 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
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?
Time to fall asleep (time frame: 14 days). 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 9 Nov 2011; AzTrials last refreshed its copy on 6 Nov 2026.