Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children's Hospital Medical Center, Cincinnati | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To examine sleep changes following therapeutic drug interventions designed to promote sleep.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zolpidem | Experimental | zolpidem or ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization |
|
| ramelteon | Active Comparator | ramelteon or zolpidem dosed at 2200 and 0200 per the feeding tube depending on randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zolipidem | Drug | zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Polysomnography Data | Determine if intervention product elicits more total sleep time | 2 weeks postburn |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | evaluate the PK of zolpidem following standard dosing practices | 2 weeks postburn |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michele M Gottschlich, PhD | Shriners Hospital for Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospital for Children | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25766031 | Background | 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. | |
| 25185933 | Background | Stockmann 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Zolpidem First, Then Ramelteon | medication dosed at 2200 and 0200 per feeding tube washout with no sleep meds (3 nights); zolpidem (x4 nights); washout (x3 nights); then ramelteon (x4 nights) |
| FG001 | Ramelteon, Then Zolpidem | medication dosed at 2200 and 0200 per the feeding tube washout with no sleep meds (x3 nights); ramelteon (x4 nights); washout (x3 nights); then zolpidem (x 4 nights) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There were ten patients total, crossover design, so each of the 10 patients received both zolpidem and ramelteon.
Mean age 7.8 years
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Zolpidem First, Then Ramelteon | dosed at 2200 and 0200 per the feeding tube |
| BG001 | Ramelteon First, Then Zolpidem | dosed at 2200 and 0200 per the feeding tube |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Polysomnography Data | Determine if intervention product elicits more total sleep time | Posted | Mean | Standard Error | minutes | 2 weeks postburn |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zolpidem | medication dosed at 2200 and 0200 per feeding tube zolipidem: dosed at 2200 and 0200 per feeding tube |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michele Gottschlich PhD | Shriners Hospitals for Children | 513-872-6298 | mgottschlich@shrinenet.org |
Not provided
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| C495910 | ramelteon |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ramelteon | Drug | ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization |
|
|
| 24365985 | Background | Stockmann 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Pharmacokinetics | evaluate the PK of zolpidem following standard dosing practices | Not Posted | 2 weeks postburn |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Ramelteon | dosed at 2200 and 0200 per the feeding tube ramelteon: medication dosed at 2200 and 0200 per feeding tube | 0 | 10 | 0 | 10 |
Not provided
Not provided
Not provided