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1 parent 867dbf0 commit c7f90554653157f01280d6b4102c783cbb1ada29 @micheldumontier committed Oct 27, 2013
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-<?xml version="1.0" encoding="UTF-8"?>
-<clinical_study>
- <required_header>
- <download_date>Information obtained from ClinicalTrials.gov on March 08, 2010</download_date>
- <link_text>Link to the current ClinicalTrials.gov record.</link_text>
- <url>http://clinicaltrials.gov/show/NCT00000102</url>
- </required_header>
- <id_info>
- <org_study_id>NCRR-M01RR01070-0506</org_study_id>
- <secondary_id>M01RR01070</secondary_id>
- <nct_id>NCT00000102</nct_id>
- </id_info>
- <brief_title>Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets</brief_title>
- <sponsors>
- <lead_sponsor>
- <agency>National Center for Research Resources (NCRR)</agency>
- </lead_sponsor>
- </sponsors>
- <source>National Center for Research Resources (NCRR)</source>
- <oversight_info>
- <authority>United States: Federal Government</authority>
- </oversight_info>
- <brief_summary>
- <textblock>
- This study will test the ability of extended release nifedipine (Procardia XL), a blood
- pressure medication, to permit a decrease in the dose of glucocorticoid medication children
- take to treat congenital adrenal hyperplasia (CAH).
- </textblock>
- </brief_summary>
- <detailed_description>
- <textblock>
- This protocol is designed to assess both acute and chronic effects of the calcium channel
- antagonist, nifedipine, on the hypothalamic-pituitary-adrenal axis in patients with
- congenital adrenal hyperplasia. The multicenter trial is composed of two phases and will
- involve a double-blind, placebo-controlled parallel design. The goal of Phase I is to
- examine the ability of nifedipine vs. placebo to decrease adrenocorticotropic hormone (ACTH)
- levels, as well as to begin to assess the dose-dependency of nifedipine effects. The goal
- of Phase II is to evaluate the long-term effects of nifedipine; that is, can attenuation of
- ACTH release by nifedipine permit a decrease in the dosage of glucocorticoid needed to
- suppress the HPA axis? Such a decrease would, in turn, reduce the deleterious effects of
- glucocorticoid treatment in CAH.
- </textblock>
- </detailed_description>
- <overall_status>Completed</overall_status>
- <phase>Phase 1/Phase 2</phase>
- <study_type>Interventional</study_type>
- <study_design>Treatment, Double-Blind, Placebo Control, Parallel Assignment</study_design>
- <condition>Congenital Adrenal Hyperplasia</condition>
- <intervention>
- <intervention_type>Drug</intervention_type>
- <intervention_name>Nifedipine</intervention_name>
- </intervention>
- <eligibility>
- <criteria>
- <textblock>
- Inclusion Criteria:
-
- - diagnosed with Congenital Adrenal Hyperplasia (CAH)
-
- - normal ECG during baseline evaluation
-
- Exclusion Criteria:
-
- - history of liver disease, or elevated liver function tests
-
- - history of cardiovascular disease
- </textblock>
- </criteria>
- <gender>Both</gender>
- <minimum_age>14 Years</minimum_age>
- <maximum_age>35 Years</maximum_age>
- <healthy_volunteers>No</healthy_volunteers>
- </eligibility>
- <location>
- <facility>
- <name>Medical University of South Carolina</name>
- <address>
- <city>Charleston</city>
- <state>South Carolina</state>
- <country>United States</country>
- </address>
- </facility>
- <status/>
- </location>
- <verification_date>January 2004</verification_date>
- <lastchanged_date>June 23, 2005</lastchanged_date>
- <firstreceived_date>November 3, 1999</firstreceived_date>
-</clinical_study>
@@ -1,165 +0,0 @@
-<?xml version="1.0" encoding="UTF-8"?>
-<clinical_study>
- <required_header>
- <download_date>Information obtained from ClinicalTrials.gov on March 10, 2010</download_date>
- <link_text>Link to the current ClinicalTrials.gov record.</link_text>
- <url>http://clinicaltrials.gov/show/NCT00576927</url>
- </required_header>
- <id_info>
- <org_study_id>R01 AG028769</org_study_id>
- <secondary_id>R01 AG028769</secondary_id>
- <nct_id>NCT00576927</nct_id>
- </id_info>
- <brief_title>Improving Sleep in Nursing Homes</brief_title>
- <official_title>Improving Sleep in Nursing Homes</official_title>
- <sponsors>
- <lead_sponsor>
- <agency>Emory University</agency>
- </lead_sponsor>
- <collaborator>
- <agency>National Institutes of Health (NIH)</agency>
- </collaborator>
- </sponsors>
- <source>Emory University</source>
- <oversight_info>
- <authority>United States: Food and Drug Administration</authority>
- <has_dmc>Yes</has_dmc>
- </oversight_info>
- <brief_summary>
- <textblock>
- Older people living in nursing homes do not sleep very well for many reasons. Sleep
- disorders such as sleep apnea (when someone briefly stops breathing during sleep), and night
- time urination, along with the problems caused by the nighttime environment of the nursing
- home, such as noise and disruptive care routines can all contribute. Poor sleep can lead to
- other health problems or make existing health problems worse.
-
- This study will evaluate how well a sleep hygiene intervention and a medication for sleep
- (ramelteon (Rozerem)) work to improve sleep in nursing home residents with poor sleep.
- Ramelteon is FDA approved and has been tested in older adults living in the community, but
- not in older adults living in nursing homes. We expect sleep to improve on the study drug
- along with the sleep hygiene intervention, in comparison to placebo along with the sleep
- hygiene intervention. Based on adverse events reported in previous samples of older
- subjects, we expect the study drug to cause few side effects.
- </textblock>
- </brief_summary>
- <detailed_description>
- <textblock>
- This study evaluates how well Ramelteon works by measuring sleep at night and during the
- day. After consenting and final determination of eligibility, participants will complete a
- baseline phase to assess usual sleep, as well as daytime alertness and activity , thinking
- and memory, walking and balance (among those who walk and/or stand), and mood. Sleep at
- night and during the day will be objectively assessed with wrist actigraphs in all subjects.
- Approximately half will also receive polysomnography to assess nighttime sleep. Subjects
- who sleep more than 75% of the time they are in bed will not continue in the study.
- Subjects that do not have improved sleep with the sleep hygiene program will be randomized
- to one of two treatment groups - one will receive the active drug along with the sleep
- hygiene intervention and the other will receive a placebo along with the sleep hygiene
- intervention. Following randomization, subjects will complete a brief run-in phase and then
- enter the treatment phase. Assessment of sleep and other measures will be repeated.
-
- The primary hypotheses to be examined in this study are as follows:
-
- Hypothesis 1: Subjects treated with ramelteon in addition to a sleep hygiene (SHI) will
- have improved sleep latency, and as a consequence, a significant increase in actigraphically
- measured sleep efficiency, compared to subjects treated with placebo plus a SHI.
-
- Hypothesis 2: Subjects treated with ramelteon in addition to a SHI will sleep less and spend
- less time in bed during the day, be more engaged in daytime activities, and have better mood
- than subjects treated with placebo plus a SHI.
-
- Hypothesis 3: Changes in daytime sleep, time in bed during the day, engagement in
- activities, and mood will be positively correlated with improved sleep efficiency among
- subjects receiving ramelteon in addition to a SHI.
- </textblock>
- </detailed_description>
- <overall_status>Recruiting</overall_status>
- <start_date>October 2007</start_date>
- <end_date>August 2009</end_date>
- <completion_date type="Anticipated">August 2009</completion_date>
- <phase>Phase 4</phase>
- <study_type>Interventional</study_type>
- <study_design>Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study</study_design>
- <primary_outcome>
- <measure>Sleep efficiency - Actigraphy measures- average percentage of time in bed at night asleep holding constant time in bed and recording time.</measure>
- <time_frame>5 nights of measures during 3 study phases</time_frame>
- <safety_issue>No</safety_issue>
- </primary_outcome>
- <secondary_outcome>
- <measure>Other objective sleep parameters - as assessed by observations, daytime sleep, activity and behavior, PSG studies, Actigraphy Mood</measure>
- <time_frame>average of 3 of 5 nights of data</time_frame>
- <safety_issue>No</safety_issue>
- </secondary_outcome>
- <number_of_arms>2</number_of_arms>
- <enrollment type="Anticipated">835</enrollment>
- <condition>Sleep Deprivation</condition>
- <intervention>
- <intervention_type>Drug</intervention_type>
- <intervention_name>Ramelteon</intervention_name>
- <description>Subjects demonstrating low sleep efficiencies and prolonged sleep latencies, will be randomly assigned to continue to receive SHI accompanied by either placebo or Ramelteon (8 mg). Matching placebo will be obtained and the medication pre-packaged and ordered based on the randomization results.</description>
- <other_name>Rozerem</other_name>
- </intervention>
- <eligibility>
- <criteria>
- <textblock>
- Inclusion Criteria:
-
- - After initial screening and consenting, subjects with a 5-night average baseline
- sleep efficiency of less than or equal to 75% will be included
-
- Exclusion Criteria:
-
- - Less than 65 yrs old
-
- - Bedbound
-
- - Resided in NH for less than two months
-
- - Patients on Medicare Part A skilled Benefit(anticipated short length stay) -
- Terminal Illness
-
- - Unstable psychotropic drug regimen (addition, discontinuation, or change of dosage
- of any psychotropic drug in the prior two weeks) - Use of hypnotic,
- antihistamine, or benzodiazepine more than once per week during the two weeks before
- screening
-
- - Use of drugs that could potentially inhibit the metabolism of Ramelteon (ie:
- fluvoxamine, ketoconazole, fluconazole)
-
- - Use of Drugs that induce the metabolism of Ramelteon (ie: rifampin)
- </textblock>
- </criteria>
- <gender>Both</gender>
- <minimum_age>65 Years</minimum_age>
- <maximum_age>N/A</maximum_age>
- <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
- </eligibility>
- <overall_official>
- <last_name>Joseph G Ouslander, MD</last_name>
- <role>Principal Investigator</role>
- <affiliation>Emory University, School of Medicine, Geriatric Division</affiliation>
- </overall_official>
- <overall_contact>
- <last_name>Deborah R Wittig-Wells, RN, PhD</last_name>
- <phone>404-728-6906</phone>
- <email>dwittig@emory.edu</email>
- </overall_contact>
- <location>
- <facility>
- <name>A. G. Rhodes Home</name>
- <address>
- <city>Atlanta</city>
- <state>Georgia</state>
- <zip>30312</zip>
- <country>United States</country>
- </address>
- </facility>
- <status>Recruiting</status>
- </location>
- <verification_date>December 2007</verification_date>
- <lastchanged_date>December 17, 2007</lastchanged_date>
- <firstreceived_date>December 17, 2007</firstreceived_date>
- <responsible_party>
- <name_title>Dr. Joseph G. Ouslander, MD</name_title>
- <organization>Emory University, School of Medicine, Division of Geriatrics</organization>
- </responsible_party>
-</clinical_study>
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