Chronic InsomniaPhase 4NCT00492232
Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia
A Phase 4 study testing Ramelteon and zolpidem in people with Chronic Insomnia, run by Takeda at 41 sites in United States.
Trial summary
The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the discontinuation of zolpidem in subjects with chronic insomnia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Ramelteon and zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 41 sitesUnited States
- Study dates
- Apr 2007to May 2008
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic insomnia and taking greater than or equal to 10 mg zolpidem at least 4 times per week.
- Has been prescribed zolpidem for difficulty in initiating sleep.
- Must report chronic use of zolpidem greater than or equal to10 mg therapy for a minimum of 3 months prior to entry into Period 1 of the study.
- Must have taken zolpidem greater than or equal to 10 mg therapy for at least 4 of 7 days each week of the 4 weeks immediately prior to entry into the double blind phase, Period 2.
- Expressed a willingness to discontinue zolpidem therapy.
- Habitual bedtime is between 9:00 PM and 1:00 AM based on sleep history.
- Negative test result for hepatitis B surface antigen and hepatitis C virus antibody.
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Who cannot join
- Known hypersensitivity to ramelteon, zolpidem, or melatonin.
- Participated in any other investigational study and/or taken any investigational drug within 30 days prior to the first dose of run-in study medication.
- Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of run-in study medication.
- History of fibromyalgia, history of seizures, sleep apnea, restless leg syndrome, periodic leg syndrome, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
- History of drug addiction or drug abuse within the past 12 months.
- History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition revised and/or regularly consumes more than 2 alcoholic drinks per day.
Show all 33Show fewer
- Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of run-in study medication.
- Body mass index of less than 18 or greater than 34 (weight /height2).
- Any clinically important abnormal finding as documented by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
- Positive hepatitis panel.
- Known history of human immunodeficiency virus.
- Any additional conditions(s) that in the investigator's opinion would affect:
- sleep/wake function
- prohibit the subject from completing the study
- indicate that continuation in the study would not be in the best interests of the subject.
- Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:
- Melatonin
- Anxiolytics
- Antipsychotics
- Over-the-counter and prescription sedatives
- Hypnotics (excluding zolpidem)
- Narcotic analgesics
- Antidepressants
- Beta-blockers (exception is that Atenolol is permissible)
- Anticonvulsants
- St. John's wort
- Sedating H1 antihistamines
- Kava-kava
- Systemic steroids
- Ginkgo-biloba
- Respiratory stimulants
- Over-the-counter and prescription diet aids
- Sedating Decongestants
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Study site
Anaheim, California
Study site
Atlanta, Georgia
Study site
Austell, Georgia
Study site
Austin, Texas
Study site
Boise, Idaho
Study site
Chevy Chase, Maryland
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Fayetteville, Tennessee
Study site
Fort Worth, Texas
Study site
Fountain Valley, California
Study site
Greer, South Carolina
Study site
Hollywood, Florida
Study site
Hot Springs, Arkansas
Study site
Houston, Texas
Study site
Kissimmee, Florida
Study site
La Mesa, California
Study site
Lincoln, Nebraska
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Metairie, Louisiana
Study site
Naples, Florida
Study site
New York, New York
Study site
Pembroke Pines, Florida
Study site
Philadelphia, Pennsylvania
Study site
Portland, Oregon
Study site
Raleigh, North Carolina
Study site
Redlands, California
Study site
Salt Lake City, Utah
Study site
San Angelo, Texas
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
San Francisco, California
Study site
Santa Monica, California
Study site
St Louis, Missouri
Study site
Toledo, Ohio
Study site
West Seneca, New York
Study site
Wilmington, North Carolina
Study site
Winter Park, Florida
About this study
Official title: Randomized, Double Blind, Placebo-Controlled Study to Assess Whether the Administration of Ramelteon Could Facilitate the Discontinuation of Zolpidem (Ambien®) ≥10 mg Therapy in Subjects With Chronic Insomnia
The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the discontinuation of zolpidem in subjects with chronic insomnia.
Read the detailed description
Approximately 60 to 70 million adults in the United States alone are affected by insomnia. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related morbidities that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents.
Zolpidem is the most commonly prescribed hypnotic in the United States for patients suffering from insomnia.
The purpose of this study is to assess whether ramelteon therapy can facilitate the discontinuation of benzodiazepine therapy in long term users. Subject participation in this study is anticipated to be about 17 weeks.
Subjects were screened and enrolled in a 4-week placebo run-in period, may have been randomized to a 10-week double-blind treatment period, and may have completed with a 2-week open-label treatment period. In the double-blind treatment period, subjects were randomized to one of two treatments: either ramelteon 8 mg tablets taken orally once-daily with concomitant current zolpidem therapy or to placebo-matching tablets once daily with concomitant current zolpidem therapy. Subjects incrementally reduced zolpidem therapy by dose, frequency, or both for up to 10 weeks. Only those subjects who completed the double-blind treatment period and had achieved a 50% reduction in zolpidem therapy during the double-blind treatment period participated in the open-label treatment period in which 8 mg ramelteon was administered. Zolpidem consumed during the open-label treatment period was recorded.
- Conditions
- Chronic Insomnia
- Being tested
- Ramelteon and zolpidem, Placebo and zolpidem
- Keywords
- Chronic Insomnia, Sleep Initiation and Maintenance Disorder, Drug Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramelteon and zolpidemDrug
Also called Rozerem™, TAK-375, Ambien®
Ramelteon 8 mg, tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.
Placebo and zolpidemDrug
Also called Ambien®
Ramelteon placebo-matching tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon 8 mg QD and current Zolpidem therapy | Experimental | Zolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks. Receives: Drug: Ramelteon and zolpidem |
| Placebo QD and current Zolpidem therapy | Placebo comparator | Zolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks. Receives: Drug: Placebo and zolpidem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Discontinued Zolpidem Therapy
Participants reduced zolpidem incrementally from Week 3 to Week 10 of the double-blind treatment period (DBTP). A participant who did not take any zolpidem during the last 7 days of the DBTP was defined as having completely discontinued zolpidem by that time point. The number of subjects who discontinued zolpidem at the end of the DBTP was summarized.
Measured: Week 10
Secondary outcomes (13)
Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2
Dosages of zolpidem taken were recorded during Weeks 1-2 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.
Measured: Baseline and Weeks 1-2
Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4
Dosages of zolpidem taken were recorded during Weeks 3-4 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.
Measured: Baseline and Weeks 3-4
Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6
Dosages of zolpidem taken were recorded during Weeks 5-6 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.
Measured: Baseline and Weeks 5-6
Change From Baseline in Weekly Zolpidem Dosage During Weeks 7-8
Dosages of zolpidem taken were recorded during Weeks 7-8 of the double blind period. Differences in dosages from baseline were summarized.
Measured: Baseline and Weeks 7-8
Change From Baseline in Weekly Zolpidem Dosage During Weeks 9-10
Dosages of zolpidem taken were recorded during Weeks 9-10 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.
Measured: Baseline and Weeks 9-10
Change From Baseline in Weekly Zolpidem Frequency During Weeks 1-2
The number of nights zolpidem was taken was recorded during Weeks 1-2 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from BL were summarized.
Measured: Baseline and Weeks 1-2
Change From Baseline in Weekly Zolpidem Frequency During Weeks 3-4
The number of nights zolpidem was taken was recorded during Weeks 3-4 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.
Measured: Weeks 3-4
Change From Baseline in Weekly Zolpidem Frequency During Weeks 5-6
The number of nights zolpidem was taken was recorded during Weeks 5-6 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.
Measured: Weeks 5-6
Change From Baseline in Weekly Zolpidem Frequency During Weeks 7-8
The number of nights zolpidem was taken was recorded during Weeks 7-8 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.
Measured: Baseline and Weeks 7-8
Change From Baseline in Weekly Zolpidem Frequency During Weeks 9-10
The number of nights zolpidem was taken was recorded during Weeks 9-10 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.
Measured: Baseline and Weeks 9-10
Participants Who Completely Discontinued Zolpidem at the End of Double-Blind Treatment Period, by Method of Discontinuation
Participants who took no zolpidem during the last 7 days of the DBTP were completely discontinued from zolpidem. Participants who completely discontinued zolpidem via reduction in zolpidem use frequency (alone) were not summarized.
Measured: Weeks 1-10
Participants Who Achieved a 50% Reduction in Zolpidem Dosage at the End of the Double-Blind Treatment Period
Participants who achieved a 50% reduction in zolpidem dosage (or frequency) at the end of the DBTP (ie, the end of Reduction Phase 4) were summarized. The reduction in dosage at Reduction Phase 4=[1-(Reduction Phase 4 weekly dosage/baseline weekly dosage)]*100%.
Measured: Baseline and Week 10
Participants Who Achieved a 50% Reduction in Zolpidem Dosage at Any Time During the Double-Blind Treatment Period
Participants who achieved a 50% reduction in zolpidem dosage at any previously defined 2-week period (ie, reduction phase) during the DBTP were summarized. The reduction in dosage at any time=[1-(reduction phase weekly dosage/baseline weekly dosage)]*100%.
Measured: Baseline and Weeks 1-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionMar 2008
- Study completionMay 2008
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.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by TakedaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director Clinical Science, Study director, Takeda Global Research & Development Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492232
- Sponsor's protocol ID
- 01-06-TL-375-071
- Other IDs
- U1111-1114-3262
- Status last verified
- Jul 2010
- First submitted
- 25 Jun 2007
- Last updated
- 20 Jul 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo-Controlled Study to Assess Whether the Administration of Ramelteon Could Facilitate the Discontinuation of Zolpidem (Ambien®) ≥10 mg Therapy in Subjects With Chronic Insomnia
- ClinicalTrials.gov ID
- NCT00492232
- Acronym / sponsor ID
- 01-06-TL-375-071
- Conditions
- Chronic Insomnia
- Keywords
- Chronic Insomnia, Sleep Initiation and Maintenance Disorder, Drug Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 27 Jun 2007 (estimated)
- Results
- Posted 17 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the discontinuation of zolpidem in subjects with chronic insomnia.
Detailed description
Approximately 60 to 70 million adults in the United States alone are affected by insomnia. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related morbidities that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents.
Zolpidem is the most commonly prescribed hypnotic in the United States for patients suffering from insomnia.
The purpose of this study is to assess whether ramelteon therapy can facilitate the discontinuation of benzodiazepine therapy in long term users. Subject participation in this study is anticipated to be about 17 weeks.
Subjects were screened and enrolled in a 4-week placebo run-in period, may have been randomized to a 10-week double-blind treatment period, and may have completed with a 2-week open-label treatment period. In the double-blind treatment period, subjects were randomized to one of two treatments: either ramelteon 8 mg tablets taken orally once-daily with concomitant current zolpidem therapy or to placebo-matching tablets once daily with concomitant current zolpidem therapy. Subjects incrementally reduced zolpidem therapy by dose, frequency, or both for up to 10 weeks. Only those subjects who completed the double-blind treatment period and had achieved a 50% reduction in zolpidem therapy during the double-blind treatment period participated in the open-label treatment period in which 8 mg ramelteon was administered. Zolpidem consumed during the open-label treatment period was recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ramelteon 8 mg QD and current Zolpidem therapy | Experimental | Drug: Ramelteon and zolpidemZolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks. |
| Placebo QD and current Zolpidem therapy | Placebo comparator | Drug: Placebo and zolpidemZolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Chronic insomnia and taking greater than or equal to 10 mg zolpidem at least 4 times per week.
- Has been prescribed zolpidem for difficulty in initiating sleep.
- Must report chronic use of zolpidem greater than or equal to10 mg therapy for a minimum of 3 months prior to entry into Period 1 of the study.
- Must have taken zolpidem greater than or equal to 10 mg therapy for at least 4 of 7 days each week of the 4 weeks immediately prior to entry into the double blind phase, Period 2.
- Expressed a willingness to discontinue zolpidem therapy.
Key exclusion criteria (33 listed)
- Known hypersensitivity to ramelteon, zolpidem, or melatonin.
- Participated in any other investigational study and/or taken any investigational drug within 30 days prior to the first dose of run-in study medication.
- Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of run-in study medication.
- History of fibromyalgia, history of seizures, sleep apnea, restless leg syndrome, periodic leg syndrome, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
- History of drug addiction or drug abuse within the past 12 months.
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 |
|---|---|---|
| Ramelteon and zolpidemAlso: Rozerem™, TAK-375, Ambien®Ramelteon 8 mg, tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks. | Drug | Ramelteon 8 mg QD and current Zolpidem therapy |
| Placebo and zolpidemAlso: Ambien®Ramelteon placebo-matching tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks. | Drug | Placebo QD and current Zolpidem therapy |
Primary outcome
Percentage of Participants Who Discontinued Zolpidem Therapy
Time frame: Week 10
Participants reduced zolpidem incrementally from Week 3 to Week 10 of the double-blind treatment period (DBTP). A participant who did not take any zolpidem during the last 7 days of the DBTP was defined as having completely discontinued zolpidem by that time point. The number of subjects who discontinued zolpidem at the end of the DBTP was summarized.
13 secondary outcomes
Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2
Time frame: Baseline and Weeks 1-2
Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4
Time frame: Baseline and Weeks 3-4
Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6
Time frame: Baseline and Weeks 5-6
Change From Baseline in Weekly Zolpidem Dosage During Weeks 7-8
Time frame: Baseline and Weeks 7-8
Change From Baseline in Weekly Zolpidem Dosage During Weeks 9-10
Time frame: Baseline and Weeks 9-10
Change From Baseline in Weekly Zolpidem Frequency During Weeks 1-2
Time frame: Baseline and Weeks 1-2
Change From Baseline in Weekly Zolpidem Frequency During Weeks 3-4
Time frame: Weeks 3-4
Change From Baseline in Weekly Zolpidem Frequency During Weeks 5-6
Time frame: Weeks 5-6
Change From Baseline in Weekly Zolpidem Frequency During Weeks 7-8
Time frame: Baseline and Weeks 7-8
Change From Baseline in Weekly Zolpidem Frequency During Weeks 9-10
Time frame: Baseline and Weeks 9-10
Participants Who Completely Discontinued Zolpidem at the End of Double-Blind Treatment Period, by Method of Discontinuation
Time frame: Weeks 1-10
Participants Who Achieved a 50% Reduction in Zolpidem Dosage at the End of the Double-Blind Treatment Period
Time frame: Baseline and Week 10
Participants Who Achieved a 50% Reduction in Zolpidem Dosage at Any Time During the Double-Blind Treatment Period
Time frame: Baseline and Weeks 1-10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Rozerem Package InsertLink provided by the sponsor.
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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.
Medical Director Clinical Science study director
Takeda Global Research & Development Center
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ramelteon and zolpidem in people with Chronic Insomnia, run by Takeda at 41 sites 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 8 inclusion and 33 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 20 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 17 Jul 2009). 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?
Percentage of Participants Who Discontinued Zolpidem Therapy (time frame: Week 10). 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 20 Jul 2010.