Urinary RetentionPhase 2/3NCT02717975
The Effect of Catheter Valve Vs. Standard Catheter Removal in Outpatients
A Phase 2/3 study testing Use of catheter valve before 'trial removal of catheter' and Trial removal of catheter in patients with urinary retention in people with Urinary Retention, run by Medway NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
It is estimated that over 10% of men above the age of 60 will experience an episode of urinary retention over a period of 5 years and will need urethral catheter. Some of these patients are discharged from the hospital with urethral catheter, for them to attend a Trial Without Catheter (TWOC) clinic at a later date… Read more about this study
- Who is it for?
- Ages 60 to 85 years, men only
- Conditions the study is for
- Urinary Retention
- What is being tested?
- Use of catheter valve before 'trial removal of catheter' and Trial removal of catheter in patients with urinary retention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to May 2017
- Phase
- Phase 2/3
- 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 60 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged 60-85 catheterised for urinary retention and booked for outpatient removal of catheter
- Mobile patients
Who cannot join
- Who cannot consent
- Residual urine of more then 1 litre
- Abnormal renal functions
- Poor manual dexterity
- Learning difficulties/dementia.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Medway NHS Foundation Trust
Gillingham, Kent, ME7 5NY
Shikohe Masood, MD, 00441634830000 ext. 3871, shikohemasood@nhs.net
Robert Hughes, MA, 00441634830000 ext. 3129, robert.hughes@medway.nhs.uk
About this study
Official title: A Prospective, Multicenter, Randomized Trial: The Effect of Catheter Valve Vs. Standard Catheter Removal in Outpatient Settings on the Patient Discharge Timings
It is estimated that over 10% of men above the age of 60 will experience an episode of urinary retention over a period of 5 years and will need urethral catheter. Some of these patients are discharged from the hospital with urethral catheter, for them to attend a Trial Without Catheter (TWOC) clinic at a later date for catheter removal. Traditionally after catheter is removed in the clinic the nurse has to wait for up to 5 hours before the patient get the urge to pass urine and empty the bladder.
The main objective of this study is to see the effect of catheter valve on the length of clinic stay (timing of discharge)for the patients (men age 60-85) after catheter is removed.
Read more
In this study after randomization, patients in Group A (catheter valve group) will be given a catheter valve before they are sent home with the catheter.They will be asked to close the valve 3-4 hours (time required for adequate filling of bladder, which means minimum of 250 mls in bladder with natural filling) before their appointment. It is very likely that by the time these patients are seen in the TWOC clinic their bladder is already full and they will void soon after removal of catheter.The patients in Group B (control) will go home with free drainage catheter and urine bag (standard catheter removal). These patients on arrival, in the TWOC clinic will have an empty bladder when their catheter is removed, they will then drink plenty of fluids in the clinic and wait for their bladder to be full before they void spontaneously.
This study will last for one year after approval by ethical committee.
The time saved in this process would lessen patient anxiety, lead to more patients being reviewed in clinic and therefore reduced waiting times in TWOC clinics and will save money.
Read the detailed description
Men who are discharged from the hospital with urinary catheter in situ are given an appointment to come to trial TWOC (trail without catheter) clinic for removal of their catheters.
Purpose and design:
In the TWOC clinic their catheters are removed and they usually wait for up to 5 hours hours before they get an urge to pass urine and empty the bladder and then sent home by the nurse. Waiting for up to 5 hours in the clinic reduces patient satisfaction and increases their anxiety. It also keeps the urology nurse busy in the clinic. This is shown by a clinical audit, which has been carried out in our department.
The aim of this study is to find out the ways to reduce this waiting time for the patients. In this study catheter valve is used to see if it significantly reduces time spent by the patient in the TWOC clinic after catheter removal. The patients in the catheter valve group are compared to the patients who did not use the valve (this is the standard method which is currently used by most of the TWOC clinics).
Catheter valve is a device, which is attached to the end of urinary catheter and can be used easily by any one who has normal manual dexterity and no cognitive impairment.
The study proposal was developed by lead urology nurse practitioner and endorsed by the consultant urological surgeons from three different hospitals in Kent UK (Medway Maritime Hospital, Darent Valley Hospital and Maidstone Hospital).
Recruitment:
Patients will be identified and recruited in the hospital ward. The patients who are planned to go home with the catheter will be provided with the patient information leaflet about his study. They will be given 6 hours to decide if they want to participate in this study. Those patients who agree to participate will be asked to sign a written informed consent. A computer-generated randomisation will be carried out. They will be given a contact number of the urology nurse in case they have any problems or if they want to ask any questions before attending TWOC clinic.
A day after discharge urology nurse practitioner will ring the patient at home to check if the patient still wants to participate in this study. A day before their appointment for TWOC clinic urology nurse will ring the patient (in Group A, valve group) to remind him about the appointment and also remind him to close the valve 3-4 hours before appointment time and patients in both groups (Group A and Group B) to drink three glasses of water before coming to the hospital for catheter removal. Patients will be informed that they can withdraw from the study at any point.
Inclusion and exclusion:
A strict inclusion and exclusion criteria will be observed. Vulnerable men with learning difficulties/dementia/Alzheimer's disease or those with poor manual dexterity will not be included.
Consent:
Written informed consent will be used after patients has read the patient information leaflet and the study has been verbally explained to the patient by the researchers.
Risks, burdens and benefits
There is no potential risk to the patients associated with the planned intervention.The vulnerable adults with learning difficulties/Dementia and poor manual dexterity will be excluded. In the intervention arm (GROUP A: patient with valve) the patient may get a pain with strong desire to pass urine or start bypassing catheter much before 3 hours after closing the valve. In this case patients will be instructed to open the valve and drain the urine. (These patients will be excluded).
If there is significant reduction (one hour or more) in the time spent in the clinic for the valve group noted in this study that will help in decreasing patient's anxiety, improved efficacy of the TWOC clinic and reduce the cost of running the TWOC clinic.
Confidentiality:
The data will be recorded electronically and will be saved in a password protected computer. The researchers and statistician can only access it.
Conflict of interest:
There is no conflict of interest. All the researchers will sign the form.
- Conditions
- Urinary Retention
- Being tested
- Use of catheter valve before 'trial removal of catheter', Trial removal of catheter in patients with urinary retention
- Keywords
- Urinary retention, trial removal of catheter, valve
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of catheter valve before 'trial removal of catheter'Procedure or surgery
The investigators are comparing two groups of patients (Group A) Trial removal of urinary catheter in patients with urinary retention after applying catheter valve and closing it 3-4 hours before catheter removal.
Trial removal of catheter in patients with urinary retentionProcedure or surgery
The investigators are comparing two groups of patients (Group B) Trial removal of urinary catheter in patients with urinary retention without using catheter valve - 'Traditional method'
| Study group | Role | What they receive |
|---|---|---|
| Without valve | Active comparator | Trial removal of catheter without catheter valve in patients with urinary retention. These are those patients who have catheter on free drainage, attend the clinic for catheter removal and bladder to be filled naturally ( which may take upto 4-5 hours). After removal of catheter they will be asked to drink plenty of fluids while waiting for the bladder to fill up.
This is the traditional method of catheter removal. Receives: Procedure: Trial removal of catheter in patients with urinary retention |
| With valve | Experimental | Trial removal of catheter in patients with urinary retention with closed catheter valve. These patients will be asked to close the valve 3-4 hours before attending the clinic prior to catheter removal. Here the intervention is catheter valve that allows bladder to be comfortably full by the time patient arrives in the clinic. By this intervention the investigators hypothesise that the investigators can save the clinic time as the patient will not need to wait for natural bladder filling which generally takes 4-5 hours.
Intervention: Urinary catheter valve Receives: Procedure: Use of catheter valve before 'trial removal of catheter' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to spontaneous void after catheter removal
The primary outcome measure of this study is to see if usage of catheter valve results in early spontaneous voiding after catheter removal and thus significantly reduces the time spent by these patients in the clinic.
Measured: On the day of catheter removal
Secondary outcomes (3)
Complications associated with valve
To see if the patients with the catheter valve have more complications (catheter bypass, urinary tract infection and pain).
Measured: On the day of catheter removal
Reduction in clinic waiting time (hours)
To see if usage of catheter valve results in early discharge after catheter removal resulting in reduction of time spent in the clinic (in hours)
Measured: On the day of catheter removal
Reduction in the cost of running the clinic
To see if reduction in the time spent by the catheter valve patients results in reducing the cost of running of the TWOC (Trial without catheter) clinic (in British Pound Sterling).
Measured: On the day of catheter removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medway NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shikohe Masood, Medway NHS Foundation Trust
- Investigators
- Shikohe Masood, MD, Principal investigator, Medway NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717975
- Sponsor's protocol ID
- 191435
- Status last verified
- Mar 2016
- First submitted
- 20 Jan 2016
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA, Lieber MM. Natural history of prostatism: risk factors for acute urinary retention. J Urol. 1997 Aug;158(2):481-7. doi: 10.1016/s0022-5347(01)64508-7.
PubMed 9224329Lyth DR, Braslis K, Iacovou JW. The infusion trial of micturition. Br J Urol. 1997 Jan;79(1):94-5. doi: 10.1046/j.1464-410x.1997.30520.x.
PubMed 9043505Boccola MA, Sharma A, Taylor C, Wong LM, Travis D, Chan S. The infusion method trial of void vs standard catheter removal in the outpatient setting: a prospective randomized trial. BJU Int. 2011 Apr;107 Suppl 3:43-6. doi: 10.1111/j.1464-410X.2011.10044.x.
PubMed 21492377Du J, Marshall D, Leyland J, Shaw L, Broome KE, Mason DF. Prospective, multicentre, randomized controlled trial of bladder filling prior to trial of void on the timing of discharge. ANZ J Surg. 2013 Apr;83(4):239-42. doi: 10.1111/j.1445-2197.2012.06253.x. Epub 2012 Sep 18.
PubMed 22984818Wilson C, Sandhu SS, Kaisary AV. A prospective randomized study comparing a catheter-valve with a standard drainage system. Br J Urol. 1997 Dec;80(6):915-7. doi: 10.1046/j.1464-410x.1997.00473.x.
PubMed 9439409German K, Rowley P, Stone D, Kumar U, Blackford HN. A randomized cross-over study comparing the use of a catheter valve and a leg-bag in urethrally catheterized male patients. Br J Urol. 1997 Jan;79(1):96-8. doi: 10.1046/j.1464-410x.1997.30321.x.
PubMed 9043506
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Trial: The Effect of Catheter Valve Vs. Standard Catheter Removal in Outpatient Settings on the Patient Discharge Timings
- ClinicalTrials.gov ID
- NCT02717975
- Acronym / sponsor ID
- 191435
- Conditions
- Urinary Retention
- Keywords
- Urinary retention, trial removal of catheter, valve
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medway NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 24 Mar 2016 (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.
It is estimated that over 10% of men above the age of 60 will experience an episode of urinary retention over a period of 5 years and will need urethral catheter. Some of these patients are discharged from the hospital with urethral catheter, for them to attend a Trial Without Catheter (TWOC) clinic at a later date for catheter removal. Traditionally after catheter is removed in the clinic the nurse has to wait for up to 5 hours before the patient get the urge to pass urine and empty the bladder.
The main objective of this study is to see the effect of catheter valve on the length of clinic stay (timing of discharge)for the patients (men age 60-85) after catheter is removed.
In this study after randomization, patients in Group A (catheter valve group) will be given a catheter valve before they are sent home with the catheter.They will be asked to close the valve 3-4 hours (time required for adequate filling of bladder, which means minimum of 250 mls in bladder with natural filling) before their appointment. It is very likely that by the time these patients are seen in the TWOC clinic their bladder is already full and they will void soon after removal of catheter.The patients in Group B (control) will go home with free drainage catheter and urine bag (standard catheter removal). These patients on arrival, in the TWOC clinic will have an empty bladder when their catheter is removed, they will then drink plenty of fluids in the clinic and wait for their bladder to be full before they void spontaneously.
This study will last for one year after approval by ethical committee.
The time saved in this process would lessen patient anxiety, lead to more patients being reviewed in clinic and therefore reduced waiting times in TWOC clinics and will save money.
Detailed description
Men who are discharged from the hospital with urinary catheter in situ are given an appointment to come to trial TWOC (trail without catheter) clinic for removal of their catheters.
Purpose and design:
In the TWOC clinic their catheters are removed and they usually wait for up to 5 hours hours before they get an urge to pass urine and empty the bladder and then sent home by the nurse. Waiting for up to 5 hours in the clinic reduces patient satisfaction and increases their anxiety. It also keeps the urology nurse busy in the clinic. This is shown by a clinical audit, which has been carried out in our department.
The aim of this study is to find out the ways to reduce this waiting time for the patients. In this study catheter valve is used to see if it significantly reduces time spent by the patient in the TWOC clinic after catheter removal. The patients in the catheter valve group are compared to the patients who did not use the valve (this is the standard method which is currently used by most of the TWOC clinics).
Catheter valve is a device, which is attached to the end of urinary catheter and can be used easily by any one who has normal manual dexterity and no cognitive impairment.
The study proposal was developed by lead urology nurse practitioner and endorsed by the consultant urological surgeons from three different hospitals in Kent UK (Medway Maritime Hospital, Darent Valley Hospital and Maidstone Hospital).
Recruitment:
Patients will be identified and recruited in the hospital ward. The patients who are planned to go home with the catheter will be provided with the patient information leaflet about his study. They will be given 6 hours to decide if they want to participate in this study. Those patients who agree to participate will be asked to sign a written informed consent. A computer-generated randomisation will be carried out. They will be given a contact number of the urology nurse in case they have any problems or if they want to ask any questions before attending TWOC clinic.
A day after discharge urology nurse practitioner will ring the patient at home to check if the patient still wants to participate in this study. A day before their appointment for TWOC clinic urology nurse will ring the patient (in Group A, valve group) to remind him about the appointment and also remind him to close the valve 3-4 hours before appointment time and patients in both groups (Group A and Group B) to drink three glasses of water before coming to the hospital for catheter removal. Patients will be informed that they can withdraw from the study at any point.
Inclusion and exclusion:
A strict inclusion and exclusion criteria will be observed. Vulnerable men with learning difficulties/dementia/Alzheimer's disease or those with poor manual dexterity will not be included.
Consent:
Written informed consent will be used after patients has read the patient information leaflet and the study has been verbally explained to the patient by the researchers.
Risks, burdens and benefits
There is no potential risk to the patients associated with the planned intervention.The vulnerable adults with learning difficulties/Dementia and poor manual dexterity will be excluded. In the intervention arm (GROUP A: patient with valve) the patient may get a pain with strong desire to pass urine or start bypassing catheter much before 3 hours after closing the valve. In this case patients will be instructed to open the valve and drain the urine. (These patients will be excluded).
If there is significant reduction (one hour or more) in the time spent in the clinic for the valve group noted in this study that will help in decreasing patient's anxiety, improved efficacy of the TWOC clinic and reduce the cost of running the TWOC clinic.
Confidentiality:
The data will be recorded electronically and will be saved in a password protected computer. The researchers and statistician can only access it.
Conflict of interest:
There is no conflict of interest. All the researchers will sign the form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without valve | Active comparator | Procedure: Trial removal of catheter in patients with urinary retentionTrial removal of catheter without catheter valve in patients with urinary retention. These are those patients who have catheter on free drainage, attend the clinic for catheter removal and bladder to be filled naturally ( which may take upto 4-5 hours). After removal of catheter they will be asked to drink plenty of fluids while waiting for the bladder to fill up. This is the traditional method of catheter removal. |
| With valve | Experimental | Procedure: Use of catheter valve before 'trial removal of catheter'Trial removal of catheter in patients with urinary retention with closed catheter valve. These patients will be asked to close the valve 3-4 hours before attending the clinic prior to catheter removal. Here the intervention is catheter valve that allows bladder to be comfortably full by the time patient arrives in the clinic. By this intervention the investigators hypothesise that the investigators can save the clinic time as the patient will not need to wait for natural bladder filling which generally takes 4-5 hours. Intervention: Urinary catheter valve |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men aged 60-85 catheterised for urinary retention and booked for outpatient removal of catheter
- Mobile patients
Key exclusion criteria (5 listed)
- Who cannot consent
- Residual urine of more then 1 litre
- Abnormal renal functions
- Poor manual dexterity
- Learning difficulties/dementia.
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 |
|---|---|---|
| Use of catheter valve before 'trial removal of catheter'The investigators are comparing two groups of patients (Group A) Trial removal of urinary catheter in patients with urinary retention after applying catheter valve and closing it 3-4 hours before catheter removal. | Procedure or surgery | With valve |
| Trial removal of catheter in patients with urinary retentionThe investigators are comparing two groups of patients (Group B) Trial removal of urinary catheter in patients with urinary retention without using catheter valve - 'Traditional method' | Procedure or surgery | Without valve |
Primary outcome
Time to spontaneous void after catheter removal
Time frame: On the day of catheter removal
The primary outcome measure of this study is to see if usage of catheter valve results in early spontaneous voiding after catheter removal and thus significantly reduces the time spent by these patients in the clinic.
3 secondary outcomes
Complications associated with valve
Time frame: On the day of catheter removal
Reduction in clinic waiting time (hours)
Time frame: On the day of catheter removal
Reduction in the cost of running the clinic
Time frame: On the day of catheter removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
- Background: PubMed 9224329Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA, Lieber MM. Natural history of prostatism: risk factors for acute urinary retention. J Urol. 1997 Aug;158(2):481-7. doi: 10.1016/s0022-5347(01)64508-7.
- Background: PubMed 9043505Lyth DR, Braslis K, Iacovou JW. The infusion trial of micturition. Br J Urol. 1997 Jan;79(1):94-5. doi: 10.1046/j.1464-410x.1997.30520.x.
- Background: PubMed 21492377Boccola MA, Sharma A, Taylor C, Wong LM, Travis D, Chan S. The infusion method trial of void vs standard catheter removal in the outpatient setting: a prospective randomized trial. BJU Int. 2011 Apr;107 Suppl 3:43-6. doi: 10.1111/j.1464-410X.2011.10044.x.
- Background: PubMed 22984818Du J, Marshall D, Leyland J, Shaw L, Broome KE, Mason DF. Prospective, multicentre, randomized controlled trial of bladder filling prior to trial of void on the timing of discharge. ANZ J Surg. 2013 Apr;83(4):239-42. doi: 10.1111/j.1445-2197.2012.06253.x. Epub 2012 Sep 18.
- Background: PubMed 9439409Wilson C, Sandhu SS, Kaisary AV. A prospective randomized study comparing a catheter-valve with a standard drainage system. Br J Urol. 1997 Dec;80(6):915-7. doi: 10.1046/j.1464-410x.1997.00473.x.
- Background: PubMed 9043506German K, Rowley P, Stone D, Kumar U, Blackford HN. A randomized cross-over study comparing the use of a catheter valve and a leg-bag in urethrally catheterized male patients. Br J Urol. 1997 Jan;79(1):96-8. doi: 10.1046/j.1464-410x.1997.30321.x.
- Individual participant dataSharing planned: Undecided
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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.
Shikohe Masood, MD principal investigator
Medway NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Use of catheter valve before 'trial removal of catheter' and Trial removal of catheter in patients with urinary retention in people with Urinary Retention, run by Medway NHS Foundation Trust 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 2 inclusion and 5 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 28 Mar 2016. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shikohe Masood, MD (00441634830000 ext. 3781, shikohemasood@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to spontaneous void after catheter removal (time frame: On the day of catheter removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02717975, which also lists 6 linked publications.
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 28 Mar 2016.