ObesityPhase 1NCT01597609
A Study to Characterise the Physiology of Weight Loss and Regain Under Dietary, Behavioural and Pharmacological Interventions in Healthy Obese Subjects
A Phase 1 study testing sibutramine in people with Obesity, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
Approximately 60 obese, but otherwise healthy, subjects will be assessed in this benchmark study to investigate the physiological changes associated with weight loss and regain. The aim is to estimate the changes in body composition during and after three interventions (i) calorie restricted diet + a marketed… Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- sibutramine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2008to 4 Mar 2010
- Phase
- Phase 1
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a healthy male or female adult subject aged 20 to 55 years, inclusive.
- Subjects will be allowed in the study if they have medical conditions, such as asthma, which will not compromise the validity of the study in the opinion of the Principal Investigator and Medical Advisor.
- BMI within the range 30.0 to 40.0 kg/m2 inclusive.
- Has been obese from approximately the age of 18 or above.
- Has demonstrated previous weight loss sustained for a minimum of one month.
- Pre-menopausal female subjects of child bearing potential who are not pregnant or breast feeding will be eligible to participate if they comply with the following: Abstinence.
Show all 9Show fewer
- The lifestyle of female subjects should be such that there is complete abstinence from intercourse from at least 30 days prior to receiving study medication and to continue until 30 days beyond the last study event, or 5 half lives of the study medication, whichever is the longest. If a subject claims abstinence as their method of contraception, they must agree to use a double barrier method (condoms, cervical/vault cap or diaphragm plus spermicide) should they become sexually active during the time frame described above. One of the following methods is acceptable as the sole method of contraception if there is indisputable data that it is >99% effective, otherwise it should be used with a barrier method (condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository): Documented tubal ligation, IUD or IUS, Oral contraception, Male partner sterilization (vasectomy) at least 6 months prior to the female subject's entry into the study and is the sole partner for that female subject. Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository (Appendix 3).
- Subject has provided signed and dated, written informed consent prior to enrolment in the study.
- The subject is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions.
Who cannot join
- Has either a previous disease or current medical condition, which as judged by the Investigator, may affect the interpretation of data. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease or endocrine disease.
- Currently has closed angle glaucoma.
- Has prostatic hypertrophy or hyperplasia.
- Females who are post-menopausal (post-menopausal females defined as being amenorrhoeic for more than 2 years with an appropriate clinical profile, e.g. history of vasomotor symptoms and confirmed by an FSH ≥ 40 mIU/mL).
- Known history of panic attacks and/or claustrophobia or other conditions precluding safe DEXA and Echo MRI-AH scans according to local guidelines, (e.g., pacemaker, hearing aid, metallic body piercing and/or other metal implants) or in the opinion of the Investigator the subject exceeds size limitations for the instruments.
- Has a history of clinically significant eating disorders (diagnosed and/or treated) such as previous anorexia nervosa, binge-eating disorder or bulimia nervosa.
Show all 38Show fewer
- Has a recent history of weight loss (or gain) defined as a change of ≥ 5 % in the 3 months prior to screening.
- Has a history of being obese in childhood.
- Has had bariatric surgical intervention for obesity.
- Has a confirmed diagnosis of polycystic ovary syndrome.
- Has a history of alcohol or substance abuse or dependence in the 6 months prior to screening as determined by the Investigator. Abuse of alcohol, defined for males, as an average weekly intake of greater than 21 units (or an average daily intake of greater than 3 units), or defined for females, as an average weekly intake of greater than 14 units (or an average daily intake of greater than 2 units). One unit is equivalent to a half-pint (220mL) of beer or 1 (25mL) measure of spirits or 1 glass (125mL) of wine.
- Subjects will not be eligible if they plan to alter their current smoking (or other tobacco use) status during the course of the study, or if they have quit smoking less than 3 months prior to screening. Because of the effects of tobacco smoke on biomarkers, subjects may be classified as 'never smokers' or 'current smokers (abstaining at study visit) + former smokers'.
- Subjects who could not refrain from smoking during the time of the visit in the unit.
- Has a positive urine drug test at screening or pre-intervention. At a minimum, subjects will be screened for amphetamines, barbiturates, cocaine, opiates, cannabinoids, and benzodiazepines, and may be screened randomly throughout the study.
- Positive results for hepatitis C antibodies, hepatitis B surface antigen, or HIV at screening. If negative results have been obtained in the last 6 months, it is not necessary to repeat the tests unless indicated by clinical judgment.
- Has a documented history of hepatobiliary disease or hepatic enzyme elevation including any one of the following: ALT or AST > 2.5 times the upper limit of normal at screening or pre-intervention Total bilirubin > 1.5 times the upper limit of normal at screening or pre-intervention.
- Subjects above this limit may only be included if direct bilirubin is within normal limits, which would be consistent with Gilbert's disease.
- Fasting triglycerides > 600mg/dL at screening or pre-intervention. If receiving lipidlowering therapy, then the subject must have been on stable doses for at least 3 months prior to screening.
- Has known type 1 or type 2 diabetes mellitus; or has fasting plasma glucose ≥ 126mg/dL (7.0 mmol/L) at screening. Subjects who fall outside this range but below 140 mg/dL fasting will be evaluated for inclusion by the PI or designee.
- Has a thyroid disorder that is not under adequate control with a stable dose of hormone replacement for at least 3 months prior to screening. Inadequate control is defined as a TSH level below the lower limit of the reference range (LLRR) or > 1.5
- × ULRR at screening.
- Has a systolic BP above 150 mmHg and/or diastolic BP above 90 mmHg at screening. If receiving anti-hypertensive therapy, then the subject must have been on stable doses for at least 3 months prior to screening.
- Is incapable or unwilling to participate in a moderate walking exercise program.
- Is pregnant or planning a pregnancy in the following 27 weeks from screening.
- Has any clinically significant abnormality identified on the medical or laboratory evaluation, including 12-lead ECG. A subject with a clinically significant abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures. Any questions regarding the significance of abnormal clinical findings in screening results should be discussed with the GSK Medical Monitor.
- Exclusions relating to concomitant preparations and medications: use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (which ever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Sponsor the medication will not interfere with the study procedures or compromise subject safety.
- Planning to commence or stop HRT or oral contraceptives during the course of the study. Female subjects who are taking an oral contraceptive preparation at the time of screening may be eligible for enrollment in the study.
- Use of weight loss drugs within 3 months of date of randomization.
- Use of any oral anti-diabetic medication. (including metformin, sulphonylureas, thiazolidinediones, GLP-1 agonist, DDPIV inhibitors).
- Use of anti-depressants (SSRI, tricyclic, bupropion etc) within 3 months of screening.
- Use of diuretics (other than stable dosing of HCTZ), systemic corticosteroids (inhaled and intranasal corticosteroids are permitted), or any other medication within 3 weeks prior to any scheduled dose of study medication that may result in electrolyte depletion.
- Use of warfarin, digoxin, oral anti-coagulants (other than aspirin and non-steroidal anti-inflammatory drugs), or antiretroviral medications.
- Use of macrolide antibiotics during the interventional part of the study.
- Use of any investigational drug or device during the study or in the 30 days prior to first dosing with study medication.
- History or presence of allergy or hypersensitivity to sibutramine or any of its components, or drugs of this class, or a history of drug or other allergy that, in the opinion of the primary investigator, contraindicates study participation.
- Has donated 500 or more milliliters of blood within 56 days prior to dosing or has the intention of donating blood the month after completing the study.
- Is unwilling to adhere to protocol-stated restrictions while participating in the study.
- The Investigator considers the subject unfit for the study as a result of the medical interview, physical examination, or screening investigations.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 2GG
About this study
Official title: A Single-blind, Randomised, Placebo-controlled, Parallel Group, Incomplete Block Design, Benchmark Study to Characterise the Physiology of Weight Loss and Regain Under Dietary, Behavioural and Pharmacological Interventions in Healthy Obese Subjects
Approximately 60 obese, but otherwise healthy, subjects will be assessed in this benchmark study to investigate the physiological changes associated with weight loss and regain. The aim is to estimate the changes in body composition during and after three interventions (i) calorie restricted diet + a marketed anti-obesity drug (sibutramine )(ii) calorie restricted diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise. The interventions will last 12 weeks, after which there is a further 12 week observation period during which subjects will return to their normal lifestyle and are expected to regain weight. Additionally, a range of biomarkers may be evaluated to determine whether there are correlations at early and late time points with weight and fat loss and weight and fat regain. The changes in body composition and other biomarkers will be used to determine whether mathematical models can be built that predict the weight loss and regain of individual subjects. In addition, the usefulness of tools that may aid the physiological characterisation of weight loss/regain will be assessed, in particular methods for measuring energy expenditure and energy intake such as ambulatory activity meter, Sussex Ingestion Pattern Monitor ™ (SIPM), hunger-satiety VAS, indirect calorimetry and, if available, the Theranos in-home graphical user interface (GUI) portal. Knowledge of the body composition changes resulting from these typical weight loss interventions and predictive markers of response would facilitate the design of future studies for novel anti-obesity agents and allow earlier, more informed triaging of NCEs.
- Conditions
- Obesity
- Being tested
- sibutramine, sibutramine placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sibutramineDrug
10 mg, taken orally once per day for 12 weeks
sibutramine placeboOther
taken orally once per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | - 600 Kcal deficit, Sibutramine placebo Receives: Other: sibutramine placebo |
| Cohort B | Experimental | - 600 Kcal deficit, Sibutramine 10 mg once daily Receives: Drug: sibutramine |
| Cohort C | Experimental | - 600 Kcal deficit, Moderate exercise (The energy expenditure will be equivalent to 30 minutes of brisk walking/5 times week i.e. ~1,000 Kcal/week) /sibutramine placebo Receives: Other: sibutramine placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of body composition (fat mass, lean mass and total body water) using Echo MRI-AH and DEXA during the intervention and follow-up phases
estimate the changes during and after three interventions: (i) calorie restricted diet + a marketed anti-obesity drug (sibutramine), (ii) calorie restricted diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise + sibutramine placebo
Measured: 24 Weeks
Measures of body weight and body mass index (BMI) during the intervention and follow-up phases.
estimate the changes during and after three interventions: (i) calorie restricted diet + a marketed anti-obesity drug (sibutramine), (ii) calorie restricted diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise + sibutramine placebo
Measured: 24 weeks
Measures of waist and hip circumference during the intervention and follow-up phases.
estimate the changes during and after three interventions: (i) calorie restricted diet + a marketed anti-obesity drug (sibutramine), (ii) calorie restricted diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise + sibutramine placebo
Measured: 24 weeks
Secondary outcomes (4)
Mathematical models that use biomarkers of (i) body composition and metabolic status, (ii) macronutrient intake, and (iii) energy expenditure to predict later changes in weight and body composition during the intervention and follow-up phases.
This will involve looking at the levels of a range of biomarkers including leptin and adiponectin.
Measured: 24 Weeks
Measures of energy expenditure
using (i) an ambulatory activity meter, the ambulatory activity meter Armband, (ii) by indirect calorimetry using a ventilated hood, (iii) by self-reported diary entry and (iv) the Theranos GUI, if available, during the intervention and follow-up phases.
Measured: 24 Weeks
Measures of food intake, satiety and satiation
using (i) food diaries, (ii) the Sussex Ingestion Pattern Monitor ™ (SIPM)), (iii) the Hunger, Craving, and Fullness Questionnaire (HCFQ/VAS), (iv) the Hunger/Satiety visual analogue scale and (iv) the Theranos GUI, if available, during the intervention and follow-up phases.
Measured: 24 Weeks
Measures of insulin sensitivity
calculated from fasting insulin, glucose, free fatty acids and glycerol levels during the intervention and follow-up phases.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study start22 May 2008
- Primary completion4 Mar 2010
- Study completion4 Mar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597609
- Sponsor's protocol ID
- 110739
- Status last verified
- Jun 2017
- First submitted
- 12 Apr 2012
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomised, Placebo-controlled, Parallel Group, Incomplete Block Design, Benchmark Study to Characterise the Physiology of Weight Loss and Regain Under Dietary, Behavioural and Pharmacological Interventions in Healthy Obese Subjects
- ClinicalTrials.gov ID
- NCT01597609
- Acronym / sponsor ID
- 110739
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 May 2008 (actual)
- Primary completion
- 4 Mar 2010 (actual)
- Study completion
- 4 Mar 2010 (actual)
- First posted
- 14 May 2012 (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.
Approximately 60 obese, but otherwise healthy, subjects will be assessed in this benchmark study to investigate the physiological changes associated with weight loss and regain. The aim is to estimate the changes in body composition during and after three interventions (i) calorie restricted diet + a marketed anti-obesity drug (sibutramine )(ii) calorie restricted diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise. The interventions will last 12 weeks, after which there is a further 12 week observation period during which subjects will return to their normal lifestyle and are expected to regain weight. Additionally, a range of biomarkers may be evaluated to determine whether there are correlations at early and late time points with weight and fat loss and weight and fat regain. The changes in body composition and other biomarkers will be used to determine whether mathematical models can be built that predict the weight loss and regain of individual subjects. In addition, the usefulness of tools that may aid the physiological characterisation of weight loss/regain will be assessed, in particular methods for measuring energy expenditure and energy intake such as ambulatory activity meter, Sussex Ingestion Pattern Monitor ™ (SIPM), hunger-satiety VAS, indirect calorimetry and, if available, the Theranos in-home graphical user interface (GUI) portal. Knowledge of the body composition changes resulting from these typical weight loss interventions and predictive markers of response would facilitate the design of future studies for novel anti-obesity agents and allow earlier, more informed triaging of NCEs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Other: sibutramine placebo- 600 Kcal deficit, Sibutramine placebo |
| Cohort B | Experimental | Drug: sibutramine- 600 Kcal deficit, Sibutramine 10 mg once daily |
| Cohort C | Experimental | Other: sibutramine placebo- 600 Kcal deficit, Moderate exercise (The energy expenditure will be equivalent to 30 minutes of brisk walking/5 times week i.e. ~1,000 Kcal/week) /sibutramine placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subject is a healthy male or female adult subject aged 20 to 55 years, inclusive.
- Subjects will be allowed in the study if they have medical conditions, such as asthma, which will not compromise the validity of the study in the opinion of the Principal Investigator and Medical Advisor.
- BMI within the range 30.0 to 40.0 kg/m2 inclusive.
- Has been obese from approximately the age of 18 or above.
- Has demonstrated previous weight loss sustained for a minimum of one month.
Key exclusion criteria (38 listed)
- Has either a previous disease or current medical condition, which as judged by the Investigator, may affect the interpretation of data. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease or endocrine disease.
- Currently has closed angle glaucoma.
- Has prostatic hypertrophy or hyperplasia.
- Females who are post-menopausal (post-menopausal females defined as being amenorrhoeic for more than 2 years with an appropriate clinical profile, e.g. history of vasomotor symptoms and confirmed by an FSH ≥ 40 mIU/mL).
- Known history of panic attacks and/or claustrophobia or other conditions precluding safe DEXA and Echo MRI-AH scans according to local guidelines, (e.g., pacemaker, hearing aid, metallic body piercing and/or other metal implants) or in the opinion of the Investigator the subject exceeds size limitations for the instruments.
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 |
|---|---|---|
| sibutramine10 mg, taken orally once per day for 12 weeks | Drug | Cohort B |
| sibutramine placebotaken orally once per day for 12 weeks | Other | Cohort A, Cohort C |
Primary outcome
Measures of body composition (fat mass, lean mass and total body water) using Echo MRI-AH and DEXA during the intervention and follow-up phases
Time frame: 24 Weeks
estimate the changes during and after three interventions: (i) calorie restricted diet + a marketed anti-obesity drug (sibutramine), (ii) calorie restricted diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise + sibutramine placebo
Measures of body weight and body mass index (BMI) during the intervention and follow-up phases.
Time frame: 24 weeks
estimate the changes during and after three interventions: (i) calorie restricted diet + a marketed anti-obesity drug (sibutramine), (ii) calorie restricted diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise + sibutramine placebo
Measures of waist and hip circumference during the intervention and follow-up phases.
Time frame: 24 weeks
estimate the changes during and after three interventions: (i) calorie restricted diet + a marketed anti-obesity drug (sibutramine), (ii) calorie restricted diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise + sibutramine placebo
4 secondary outcomes
Mathematical models that use biomarkers of (i) body composition and metabolic status, (ii) macronutrient intake, and (iii) energy expenditure to predict later changes in weight and body composition during the intervention and follow-up phases.
Time frame: 24 Weeks
Measures of energy expenditure
Time frame: 24 Weeks
Measures of food intake, satiety and satiation
Time frame: 24 Weeks
Measures of insulin sensitivity
Time frame: 24 Weeks
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 20 Jun 2017.
- Results for study 110739 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sibutramine in people with Obesity, run by GlaxoSmithKline at 1 site in United Kingdom.
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 9 inclusion and 38 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 Jun 2017. 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 Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Measures of body composition (fat mass, lean mass and total body water) using Echo MRI-AH and DEXA during the intervention and follow-up phases (time frame: 24 Weeks). The study lists 3 primary outcomes in all. 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 Jun 2017.