SleepPhase 2Sleep3NCT00539110
Differential Effects of Zolpidem Versus Ramelteon in Burned Children
A Phase 2 study testing zolipidem and ramelteon in people with Sleep and Burns, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
To examine sleep changes following therapeutic drug interventions designed to promote sleep. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- What is being tested?
- zolipidem and ramelteon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Nov 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Burn injury > 20% total body surface area
- Between 3 and 18 years of age
- < 7 days from acute injury
- Written informed consent and HIPPA release signed
Who cannot join
- Suspected anoxic brain injury or head injury
- Hepatic or endocrine disease
- History of alcoholism or substance abuse
- Pre-existing neurological or primary psychiatric disorder
- Medical history of pre-existing sleep disorder or lactose deficiency
- Questionable survival (<72 hrs) as decided by PI
- Receipt of drugs with known effects on sleep within 24 hrs of study entry
- No informed consent/HIPPA release
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospital for Children
Cincinnati, Ohio, 45229
About this study
Official title: Differential Effects of Zolpidem Versus Ramelteon on Nocturnal Sleep in Pediatric Burn Patients: A Prospective, Randomized Crossover Trial With Polysomnographic Recordings
To examine sleep changes following therapeutic drug interventions designed to promote sleep.
- Being tested
- zolipidem, ramelteon
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zolipidemDrug
Also called Ambien
zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization
ramelteonDrug
Also called rozerem
ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
| Study group | Role | What they receive |
|---|---|---|
| zolpidem | Experimental | zolpidem or ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization Receives: Drug: zolipidem |
| ramelteon | Active comparator | ramelteon or zolpidem dosed at 2200 and 0200 per the feeding tube depending on randomization Receives: Drug: ramelteon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography Data
Determine if intervention product elicits more total sleep time
Measured: 2 weeks postburn
Secondary outcomes (1)
Pharmacokinetics
evaluate the PK of zolpidem following standard dosing practices
Measured: 2 weeks postburn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study startDec 2009
- Primary completionDec 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Michele Gottschlich, Shriners Hospitals for Children
- Investigators
- Michele M Gottschlich, PhD, Principal investigator, Shriners Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539110
- Sponsor's protocol ID
- 09-04-07-01
- Acronym
- Sleep3
- Status last verified
- Jun 2016
- First submitted
- 2 Oct 2007
- Last updated
- 27 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Stockmann C, Spigarelli MG, Healy DP, Gottschlich MM, Kagan R, Balch AH, Sherwin C. Application of a method used to deconstruct a single dose pharmacokinetic profile from multiple dose data. Biopharm Drug Dispos. 2015 Sep;36(6):405-409. doi: 10.1002/bdd.1949. Epub 2015 Apr 21.
PubMed 25766031Stockmann C, Gottschlich MM, Healy D, Khoury JC, Mayes T, Sherwin CM, Spigarelli MG, Kagan RJ. Relationship between zolpidem concentrations and sleep parameters in pediatric burn patients. J Burn Care Res. 2015 Jan-Feb;36(1):137-44. doi: 10.1097/BCR.0000000000000164.
PubMed 25185933Stockmann C, Sherwin CM, Buterbaugh W, Spigarelli MG, Gottschlich MM, Healy D, Kagan RJ. Preliminary assessment of zolpidem pharmacokinetics in pediatric burn patients. Ther Drug Monit. 2014 Jun;36(3):295-301. doi: 10.1097/FTD.0000000000000017.
PubMed 24365985
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of Zolpidem Versus Ramelteon on Nocturnal Sleep in Pediatric Burn Patients: A Prospective, Randomized Crossover Trial With Polysomnographic Recordings
- ClinicalTrials.gov ID
- NCT00539110
- Acronym / sponsor ID
- Sleep3 / 09-04-07-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Study start
- Dec 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Oct 2007 (estimated)
- Results
- Posted 18 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine sleep changes following therapeutic drug interventions designed to promote sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zolpidem | Experimental | Drug: zolipidemzolpidem or ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization |
| ramelteon | Active comparator | Drug: ramelteonramelteon or zolpidem dosed at 2200 and 0200 per the feeding tube depending on randomization |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Burn injury > 20% total body surface area
- Between 3 and 18 years of age
- < 7 days from acute injury
- Written informed consent and HIPPA release signed
Key exclusion criteria (8 listed)
- Suspected anoxic brain injury or head injury
- Hepatic or endocrine disease
- History of alcoholism or substance abuse
- Pre-existing neurological or primary psychiatric disorder
- Medical history of pre-existing sleep disorder or lactose deficiency
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 |
|---|---|---|
| zolipidemAlso: Ambienzolpidem dosed at 2200 and 0200 per feeding tube depending on randomization | Drug | zolpidem |
| ramelteonAlso: rozeremramelteon dosed at 2200 and 0200 per feeding tube depending on randomization | Drug | ramelteon |
Primary outcome
Polysomnography Data
Time frame: 2 weeks postburn
Determine if intervention product elicits more total sleep time
1 secondary outcome
Pharmacokinetics
Time frame: 2 weeks postburn
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25766031Stockmann C, Spigarelli MG, Healy DP, Gottschlich MM, Kagan R, Balch AH, Sherwin C. Application of a method used to deconstruct a single dose pharmacokinetic profile from multiple dose data. Biopharm Drug Dispos. 2015 Sep;36(6):405-409. doi: 10.1002/bdd.1949. Epub 2015 Apr 21.
- Background: PubMed 25185933Stockmann C, Gottschlich MM, Healy D, Khoury JC, Mayes T, Sherwin CM, Spigarelli MG, Kagan RJ. Relationship between zolpidem concentrations and sleep parameters in pediatric burn patients. J Burn Care Res. 2015 Jan-Feb;36(1):137-44. doi: 10.1097/BCR.0000000000000164.
- Background: PubMed 24365985Stockmann C, Sherwin CM, Buterbaugh W, Spigarelli MG, Gottschlich MM, Healy D, Kagan RJ. Preliminary assessment of zolpidem pharmacokinetics in pediatric burn patients. Ther Drug Monit. 2014 Jun;36(3):295-301. doi: 10.1097/FTD.0000000000000017.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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.
Michele M Gottschlich, PhD principal investigator
Shriners Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zolipidem and ramelteon in people with Sleep and Burns, run by Shriners Hospitals for Children 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 4 inclusion and 8 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 27 Jul 2016. 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. 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?
Yes. Results are posted in the registry (first posted 18 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Polysomnography Data (time frame: 2 weeks postburn). 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 NCT00539110, which also lists 3 linked publications.
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 27 Jul 2016.