ComplianceNCT02397369
Evaluation of Efficacy of Different Methods of Tobacco Cessation Interventions Among BEST Employees in Mumbai
A study testing Tobacco users: Self Help, Tobacco users:Telephonic counseling and Tobacco users:Behavioural therapy Only in people with Compliance and Tobacco Use Cessation, run by Tata Memorial Hospital at 1 site in India.
Trial summary
Tobacco use is the single most preventable cause of premature adult death globally. It is one of the major causes of death and disease in India, accounting for nearly 0.9 million deaths every year. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Compliance, Tobacco Use Cessation
- What is being tested?
- Tobacco users: Self Help, Tobacco users:Telephonic counseling and Tobacco users:Behavioural therapy Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2015to Mar 2020
- Phase
- Interventional
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- BEST employees in Mumbai
Who cannot join
- BEST employees not willing to give consent
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital, Parel
Mumbai, Maharashtra, 400012
Gauravi A Mishra, M.D. PSM, +9102224177000 ext. 4634, gauravi2005@yahoo.co.in
Gauravi A Mishra, M.D.PSM
About this study
Official title: Comparative Evaluation of Efficacy of Different Methods of Tobacco Cessation Interventions Among BEST Employees in Mumbai : A Randomized Controlled Trial
Tobacco use is the single most preventable cause of premature adult death globally. It is one of the major causes of death and disease in India, accounting for nearly 0.9 million deaths every year.
Bombay Electric Supply and Transport (BEST), one of the biggest public transport undertaking in Mumbai City, has imposed a ban on tobacco use in public transport buses and under Motor Vehicle Act has empowered the drivers and bus conductors to take suitable action against commuters found to be using tobacco. However in addition to commuters using tobacco in the BEST premises, large number of bus drivers and conductors are known to use tobacco on the job. There are various approaches to a tobacco cessation programme, like behavioural therapy, pharmacotherapy, providing self help material, telephone counseling, quit lines etc.
Hence in terms of the workplace environment, understanding the factors leading to tobacco use maintenance and the effective approaches for cessation is of critical importance for formulating workplace tobacco prevention and cessation interventions that are applicable to transport work employee settings. The success of these methods needs to be comparatively evaluated among the different forms of tobacco users. Hence, the present study will be undertaken with the following objectives:
Read the detailed description
RESEARCH OBJECTIVES:
- To study the Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees in Mumbai
- To study the occupational correlates of tobacco consumption across various grades of BEST employees
- To educate them regarding hazards of tobacco.
- To offer BEST employees Preventive Oncology screening facilities and evaluate the compliance for screening and determine the rate of oral pre-cancers.
- To study the post-intervention KAP regarding tobacco
- To randomly assign the BEST employees using tobacco to one of the four tobacco cessation interventions and study the compliance to the same.
- To determine the rate of tobacco cessation after twelve months of follow-up.
- To comparatively evaluate the success of the four approaches of tobacco cessation, viz. providing self help material, telephone counseling, behavioural therapy and behavioural + pharmacotherapy, among users of different forms of tobacco.
Methodology:
Study Design: Four arm interventional study
Step 1: Around 4000 BEST employees in Mumbai will be enrolled after explaining the programme and obtaining informed consent. They will be interviewed with the help of a well structured questionnaire to collect information about their Knowledge, Attitudes and Practices (KAP) regarding tobacco, their attitudes and experiences regarding smoke free public places with specific reference to smoke free BEST buses.
Step 2: The BEST employees will be given detailed health education regarding hazards of tobacco and the need for smoke free BEST buses. The BEST employees will be invited to participate in Preventive Oncology (PO) screening (mainly oral cancer screening).
Step 3: The BEST employees will be again interviewed with the help of a well structured questionnaire to collect information of their post-intervention KAP regarding tobacco and smoke free public places.
Step 4: The BEST employees using tobacco will be registered at the Tobacco cessation clinic and will be invited to participate in the first session of tobacco cessation counseling.
The BEST employees using smoking forms of tobacco will be offered interventions and will be followed up as per the TCC protocol.
The smokeless tobacco users will be randomly assigned into one of the four groups to receive intervention. Each group of employee will receive one of the four interventions as follows: self help material, telephone counseling, behavioural therapy and behavioural + pharmacotherapy.
The pharmacotherapy intervention in the form of Nicotine Replacement Therapy comprising of Nicotine chewing gums or patches (Transdermal patches) will be based on individual need assessment to relieve withdrawal symptoms in tobacco users when trying to quit.
Nicotine Chewing Gums:
Dose: 2 mg/4 mg, 10-15 pieces per day with maximum dose of 24 pieces/day depending on cravings Total Duration: 12 weeks Duration of treatment: Higher dose for 4-6 weeks, with weaning till 2-3 months Side effects: Bad taste, Throat irritation, burning in mouth, nausea, vomiting, hiccups, increased heart beat etc
Nicotine Transdermal patches:
Dose: 7 mg/10 mg/14 mg/21 mg -for 24-hours use. Total Duration: 12 weeks Duration of treatment: Higher strength patch for 2 weeks and depending on cravings will be gradually decreased till 4 weeks Side effects: Skin irritation, dizziness, sleep problems, increased heart beat etc
Step 5: The BEST employees with lesions will be followed up at the Preventive Oncology screening clinic as per PO protocols. The tobacco users enrolled in the TCC will be followed up over a period of twelve months with three interventions in between and a post-intervention follow-up.
Variables to be estimated:
- Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees.
- The compliance for availing the services at Preventive Oncology screening facilities and Tobacco cessation clinic at the Tata Memorial Hospital
- The rate of oral pre-cancers among BEST employees.
- The post-intervention KAP regarding tobacco.
- The rate of tobacco cessation after one year follow-up.
- Compare the success of various approaches for tobacco cessation and assess the compliance for the same.
Data Analysis:
Data entry will be done in the Department of Preventive Oncology, Tata Memorial Hospital using Statistical Package for Social Sciences (SPSS) version 18. Checks for consistency, data safety and analysis will be carried out at regular intervals. Both descriptive and inferential statistics will be generated for describing variables under the study objectives.
- Conditions
- Compliance, Tobacco Use Cessation
- Being tested
- Tobacco users: Self Help, Tobacco users:Telephonic counseling, Tobacco users:Behavioural therapy Only, Tobacco users:Pharmacologic
- Keywords
- Education and evaluate post intervention KAP
- Medical subject headings
- Patient Compliance, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco users: Self HelpOther
Also called Self help
This group will be given pictorial material and minimal written materials/ pamphlets describing health hazards of smokeless forms of tobacco and tips on tobacco cessation in general. The material will be interactively tailored to individual tobacco consumption characteristics and they will be followed up after 12 months.
Tobacco users:Telephonic counselingBehavioural
Also called Telephonic
This group will be given proactive as well as reactive counseling. Medical social workers will proactively call all participants regularly and offer tobacco cessation counseling. In addition, they will call those participants who have planned their quit dates. Dedicated independent mobile numbers with 12 hours help lines will be made available to the participants to maximise the level of support. It will be scheduled in response to the needs to answer any type of help pertaining to quitting tobacco.
Tobacco users:Behavioural therapy OnlyBehavioural
- Focus Group discussion: This tobacco cessation intervention session will involve thirty minutes of focus group discussion with group behavioral therapy in groups of 5-10 individuals for reinforcement of tobacco use prevention and cessation advice. Group discussion is intended to improve understanding by exploring, sharing and reflecting psychosocial, familial, environmental issues which attribute to the problem.
- Individual tobacco cessation counseling sessions:
Individual counseling is commonly used to help people who are trying to quit tobacco. The counseling adopting an interactive problem-solving approach will be done by trained Medical Social Workers providing face-to-face sessions for 10-15 minutes per participant.
Tobacco users:PharmacologicOther
Also called Drug
Pharmaco Therapy will consist of:
Nicotine Chewing Gums:
Dose: 2 mg/4 mg, 10-15 pieces per day with maximum dose of 24 pieces/day depending on cravings Total Duration: 12 weeks Duration of treatment: Higher dose for 4-6 weeks, with weaning till 2-3 months Side effects: Bad taste, Throat irritation, burning in mouth, nausea, vomiting, hiccups, increased heart beat etc
Nicotine Transdermal patches:
Dose: 7 mg/10 mg/14 mg/21 mg -for 24-hours use. Total Duration: 12 weeks Duration of treatment: Higher strength patch for 2 weeks and depending on cravings will be gradually decreased till 4 weeks Side effects: Skin irritation, dizziness, sleep problems, increased heart beat etc
| Study group | Role | What they receive |
|---|---|---|
| Tobacco users: Self Help | Experimental | Self-help intervention is defined as any manual or programme to be used by individuals to assist a quit attempt not aided by counsellors or group support.They include written materials on the health effects of tobacco, audio-or video tape or computer programmes. Receives: Other: Tobacco users: Self Help |
| Tobacco users:Telephonic counseling | Experimental | Telephone counseling is a way of providing individual counseling via telephone conversation or telephone hotlines. It can be proactive or reactive. Receives: Behavioral: Tobacco users:Telephonic counseling |
| Tobacco users:Behavioural therapy Only | Experimental | Behavioural therapy includes multiple sessions of Focus Group Discussion (FGD) and individual tobacco cessation counseling sessions. The participants in this group will be given advice to quit tobacco via multisession formal cognitive-behavioural therapy as per the Tobacco Cessation Clinic (TCC) guidelines. Receives: Behavioral: Tobacco users:Behavioural therapy Only |
| Tobacco users:Pharmacologic | Experimental | Pharmacotherapy in the form of Nicotine Replacement Therapy based on individual need assessment to relieve withdrawal symptoms in tobacco users when trying to quit. Receives: Behavioral: Tobacco users:Behavioural therapy Only; Other: Tobacco users:Pharmacologic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees.
To study the Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees in Mumbai
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplianceStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gauravi Ashish Mishra, Tata Memorial Hospital
- Investigators
- Gauravi A Mishra, Assoc Prof, Principal investigator, Tata Memorial Hospital, MumbaiSharmila A Pimple, Professor, Principal investigator, Tata Memorial Hospital, Mumbai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397369
- Sponsor's protocol ID
- TMHPOBEST2015
- Status last verified
- Dec 2017
- First submitted
- 2 Mar 2015
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Efficacy of Different Methods of Tobacco Cessation Interventions Among BEST Employees in Mumbai : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02397369
- Acronym / sponsor ID
- TMHPOBEST2015
- Conditions
- Compliance, Tobacco Use Cessation
- Keywords
- Education and evaluate post intervention KAP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Mar 2015
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 24 Mar 2015 (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.
Tobacco use is the single most preventable cause of premature adult death globally. It is one of the major causes of death and disease in India, accounting for nearly 0.9 million deaths every year.
Bombay Electric Supply and Transport (BEST), one of the biggest public transport undertaking in Mumbai City, has imposed a ban on tobacco use in public transport buses and under Motor Vehicle Act has empowered the drivers and bus conductors to take suitable action against commuters found to be using tobacco. However in addition to commuters using tobacco in the BEST premises, large number of bus drivers and conductors are known to use tobacco on the job. There are various approaches to a tobacco cessation programme, like behavioural therapy, pharmacotherapy, providing self help material, telephone counseling, quit lines etc.
Hence in terms of the workplace environment, understanding the factors leading to tobacco use maintenance and the effective approaches for cessation is of critical importance for formulating workplace tobacco prevention and cessation interventions that are applicable to transport work employee settings. The success of these methods needs to be comparatively evaluated among the different forms of tobacco users. Hence, the present study will be undertaken with the following objectives:
Detailed description
RESEARCH OBJECTIVES:
- To study the Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees in Mumbai
- To study the occupational correlates of tobacco consumption across various grades of BEST employees
- To educate them regarding hazards of tobacco.
- To offer BEST employees Preventive Oncology screening facilities and evaluate the compliance for screening and determine the rate of oral pre-cancers.
- To study the post-intervention KAP regarding tobacco
- To randomly assign the BEST employees using tobacco to one of the four tobacco cessation interventions and study the compliance to the same.
- To determine the rate of tobacco cessation after twelve months of follow-up.
- To comparatively evaluate the success of the four approaches of tobacco cessation, viz. providing self help material, telephone counseling, behavioural therapy and behavioural + pharmacotherapy, among users of different forms of tobacco.
Methodology:
Study Design: Four arm interventional study
Step 1: Around 4000 BEST employees in Mumbai will be enrolled after explaining the programme and obtaining informed consent. They will be interviewed with the help of a well structured questionnaire to collect information about their Knowledge, Attitudes and Practices (KAP) regarding tobacco, their attitudes and experiences regarding smoke free public places with specific reference to smoke free BEST buses.
Step 2: The BEST employees will be given detailed health education regarding hazards of tobacco and the need for smoke free BEST buses. The BEST employees will be invited to participate in Preventive Oncology (PO) screening (mainly oral cancer screening).
Step 3: The BEST employees will be again interviewed with the help of a well structured questionnaire to collect information of their post-intervention KAP regarding tobacco and smoke free public places.
Step 4: The BEST employees using tobacco will be registered at the Tobacco cessation clinic and will be invited to participate in the first session of tobacco cessation counseling.
The BEST employees using smoking forms of tobacco will be offered interventions and will be followed up as per the TCC protocol.
The smokeless tobacco users will be randomly assigned into one of the four groups to receive intervention. Each group of employee will receive one of the four interventions as follows: self help material, telephone counseling, behavioural therapy and behavioural + pharmacotherapy.
The pharmacotherapy intervention in the form of Nicotine Replacement Therapy comprising of Nicotine chewing gums or patches (Transdermal patches) will be based on individual need assessment to relieve withdrawal symptoms in tobacco users when trying to quit.
Nicotine Chewing Gums:
Dose: 2 mg/4 mg, 10-15 pieces per day with maximum dose of 24 pieces/day depending on cravings Total Duration: 12 weeks Duration of treatment: Higher dose for 4-6 weeks, with weaning till 2-3 months Side effects: Bad taste, Throat irritation, burning in mouth, nausea, vomiting, hiccups, increased heart beat etc
Nicotine Transdermal patches:
Dose: 7 mg/10 mg/14 mg/21 mg -for 24-hours use. Total Duration: 12 weeks Duration of treatment: Higher strength patch for 2 weeks and depending on cravings will be gradually decreased till 4 weeks Side effects: Skin irritation, dizziness, sleep problems, increased heart beat etc
Step 5: The BEST employees with lesions will be followed up at the Preventive Oncology screening clinic as per PO protocols. The tobacco users enrolled in the TCC will be followed up over a period of twelve months with three interventions in between and a post-intervention follow-up.
Variables to be estimated:
- Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees.
- The compliance for availing the services at Preventive Oncology screening facilities and Tobacco cessation clinic at the Tata Memorial Hospital
- The rate of oral pre-cancers among BEST employees.
- The post-intervention KAP regarding tobacco.
- The rate of tobacco cessation after one year follow-up.
- Compare the success of various approaches for tobacco cessation and assess the compliance for the same.
Data Analysis:
Data entry will be done in the Department of Preventive Oncology, Tata Memorial Hospital using Statistical Package for Social Sciences (SPSS) version 18. Checks for consistency, data safety and analysis will be carried out at regular intervals. Both descriptive and inferential statistics will be generated for describing variables under the study objectives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tobacco users: Self Help | Experimental | Other: Tobacco users: Self HelpSelf-help intervention is defined as any manual or programme to be used by individuals to assist a quit attempt not aided by counsellors or group support.They include written materials on the health effects of tobacco, audio-or video tape or computer programmes. |
| Tobacco users:Telephonic counseling | Experimental | Behavioral: Tobacco users:Telephonic counselingTelephone counseling is a way of providing individual counseling via telephone conversation or telephone hotlines. It can be proactive or reactive. |
| Tobacco users:Behavioural therapy Only | Experimental | Behavioral: Tobacco users:Behavioural therapy OnlyBehavioural therapy includes multiple sessions of Focus Group Discussion (FGD) and individual tobacco cessation counseling sessions. The participants in this group will be given advice to quit tobacco via multisession formal cognitive-behavioural therapy as per the Tobacco Cessation Clinic (TCC) guidelines. |
| Tobacco users:Pharmacologic | Experimental | Behavioral: Tobacco users:Behavioural therapy Only, Other: Tobacco users:PharmacologicPharmacotherapy in the form of Nicotine Replacement Therapy based on individual need assessment to relieve withdrawal symptoms in tobacco users when trying to quit. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- BEST employees in Mumbai
Key exclusion criteria (1 listed)
- BEST employees not willing to give consent
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 |
|---|---|---|
| Tobacco users: Self HelpAlso: Self helpThis group will be given pictorial material and minimal written materials/ pamphlets describing health hazards of smokeless forms of tobacco and tips on tobacco cessation in general. The material will be interactively tailored to individual tobacco consumption characteristics and they will be followed up after 12 months. | Other | Tobacco users: Self Help |
| Tobacco users:Telephonic counselingAlso: TelephonicThis group will be given proactive as well as reactive counseling. Medical social workers will proactively call all participants regularly and offer tobacco cessation counseling. In addition, they will call those participants who have planned their quit dates. Dedicated independent mobile numbers with 12 hours help lines will be made available to the participants to maximise the level of support. It will be scheduled in response to the needs to answer any type of help pertaining to quitting tobacco. | Behavioural | Tobacco users:Telephonic counseling |
| Tobacco users:Behavioural therapy Only1. Focus Group discussion: This tobacco cessation intervention session will involve thirty minutes of focus group discussion with group behavioral therapy in groups of 5-10 individuals for reinforcement of tobacco use prevention and cessation advice. Group discussion is intended to improve understanding by exploring, sharing and reflecting psychosocial, familial, environmental issues which attribute to the problem. 2. Individual tobacco cessation counseling sessions: Individual counseling is commonly used to help people who are trying to quit tobacco. The counseling adopting an interactive problem-solving approach will be done by trained Medical Social Workers providing face-to-face sessions for 10-15 minutes per participant. | Behavioural | Tobacco users:Behavioural therapy Only, Tobacco users:Pharmacologic |
| Tobacco users:PharmacologicAlso: DrugPharmaco Therapy will consist of: Nicotine Chewing Gums: Dose: 2 mg/4 mg, 10-15 pieces per day with maximum dose of 24 pieces/day depending on cravings Total Duration: 12 weeks Duration of treatment: Higher dose for 4-6 weeks, with weaning till 2-3 months Side effects: Bad taste, Throat irritation, burning in mouth, nausea, vomiting, hiccups, increased heart beat etc Nicotine Transdermal patches: Dose: 7 mg/10 mg/14 mg/21 mg -for 24-hours use. Total Duration: 12 weeks Duration of treatment: Higher strength patch for 2 weeks and depending on cravings will be gradually decreased till 4 weeks Side effects: Skin irritation, dizziness, sleep problems, increased heart beat etc | Other | Tobacco users:Pharmacologic |
Primary outcome
Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees.
Time frame: 60 months
To study the Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees in Mumbai
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
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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.
Gauravi A Mishra, Assoc Prof principal investigator
Tata Memorial Hospital, Mumbai
Sharmila A Pimple, Professor principal investigator
Tata Memorial Hospital, Mumbai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco users: Self Help, Tobacco users:Telephonic counseling and Tobacco users:Behavioural therapy Only in people with Compliance and Tobacco Use Cessation, run by Tata Memorial Hospital at 1 site in India.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Dec 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 India. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gauravi A Mishra, Assoc Prof (+912224177000 ext. 4634, gauravi2005@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees. (time frame: 60 months). 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 22 Dec 2017.