Perioperative/Postoperative ComplicationsPhase 4NCT01690338
A Study of Residual Curarization Incidence in China
A Phase 4 study testing Vecuronium Bromide, Rocuronium and Cisatracurium in people with Perioperative/Postoperative Complications and PORC (Postoperative Residual Curarization), run by Peking University First Hospital at 22 sites in China.
Trial summary
The purpose of this study is to determine the incidence of residual curarization in PACU and relevant risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative/Postoperative Complications, PORC (Postoperative Residual Curarization)
- What is being tested?
- Vecuronium Bromide, Rocuronium and Cisatracurium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,090 participants
- Where
- 22 sitesChina
- Study dates
- Oct 2012to Dec 2014
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or older
- Nondepolarized NMBA will be given during surgery and tracheal extubation will be performed after surgery
- Willing to comply with all study procedures and provide signed and dated informed consent
Who cannot join
- Allergic reaction to gel electrode
- Neuromuscular disorders and hepatic or renal dysfunction
- Scheduled to receive mechanical ventilation therapy
- Involved in other clinical trials
- Body position and surgical procedure affecting TOF-Watch SX normal function
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites, 21 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100000
Weidong Mi, Doctor, +86 13381082966, wwdd1962@yahoo.com.cn
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Jing Zhao, Doctor, +86 13901048114, Zhaojing1009@yahoo.com.cn
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yuan Zeng, Doctor, +86 13520703600, yuan_zeng@sina.com
Yuan Zeng, Doctor
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Junmei Xu, Doctor, +86 13975148864, 13975148864@139.com
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Qulian Guo, Doctor, +86 13707315866, qulianguo@hotmail.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610000
Bin Liu, Doctor, +86 13808186401, benbinliu@yahoo.com.cn
- Recruiting
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Wenqi Huang, Doctor, +86 13802963182, huangwenqi86@yahoo.com.cn
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Qinglong Dong, Doctor, 13602837397, qldong@163.net
- Recruiting
Zhujiang Hospital Southern Medical University
Guangzhou, Guangdong, 510000
Shiyuan Xu, Doctor, +86 13609727860, xushiyuan355@yahoo.com.cn
- Recruiting
The First Affiliated Hospital Of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Shenmei Zhu, Doctor, 13857169801, smzhu20088@yahoo.com.cn
- Recruiting
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 200000
Weifeng Yu, Doctor, +86 13901961704, Ywf808@yeah.net
- Recruiting
RenJi Hospital
Shanghai, Shanghai Municipality, 200000
Xiangrui Wang, Doctor, 13701901953, xiangrui68@163.com
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200000
Qingsheng Xue, Doctor, +86 13611909814, xueqingsheng@yahoo.com.cn
- Recruiting
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200000
Yingtian Wang, Doctor, +86 13386259639, wang_didi26@yahoo.com.cn
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200000
Zhanggang Xue, Doctor, 13601914601, xuezgang@yahoo.com.cn
- Recruiting
China Medical University Hospital
Shenyang, Liaoning, 110000
Hong Ma, Doctor, +86 13840366406, mahong5466@yahoo.com
- Recruiting
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050000
Zixian Song, Doctor, +86 13400312688, zixiansong@126.com
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300000
Guolin Wang, Doctor, +86 15822855556, wang_guolin@hotmail.com
- Withdrawn
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
- Recruiting
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, 430000
Ailin Luo, Doctor, +86 13507122565, ailinluo@yahoo.cn
- Recruiting
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Qingping Wu, Doctor, +86 13971605283, Wqp1968@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Wei Zhang, Doctor, +86 13673996966, Zhangw571012@126.com
About this study
Official title: A Perspective, Multicentre, Randomized，Blind Study of Residual Curarization Incidence in China
The purpose of this study is to determine the incidence of residual curarization in PACU and relevant risk factors.
Read the detailed description
In the last twenty years, residual curarization in PACU (Post Anesthesia Care Unit) has become a common problem in clinical practice and poses high risk to patients. The residual curarization incidence of Neuromuscular blocking agents (NMBA) varies very much between different studies. These differences indicates the necessity of further study. In China, there is no common view of the harmfulness of residual curarization and its complications. The consensus on the necessity of neuromuscular transmission monitoring and neuromuscular blockade antagonist has not been reached yet. There is also no similar large-scale survey in China. In this case, the investigators conduct this large scale multicentre study, which is designed to learn the incidence of residual curarization and its complications. Further analysis of risk factors will also been made. All these efforts are hoped to fill the data gap and provide reliable evidences for rational use of NMBA.
- Being tested
- Vecuronium Bromide, Rocuronium, Cisatracurium
- Keywords
- TOFr (train of four ratio), airway extubation, PACU (postanesthesia care unit), PORC (postoperative residual curarization)
- Medical subject headings
- Postoperative Complications, Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vecuronium BromideDrug
Also called Norcuron
Administrative protocol of Vecuronium Bromide is determined by each caregiver's clinical experience.
RocuroniumDrug
Also called Esmeron
Administrative protocol of rocuronium is determined by each caregiver's clinical experience.
CisatracuriumDrug
Also called Nimbex
Administrative protocol of cisatracurium is determined by each caregiver's clinical experience
| Study group | Role | What they receive |
|---|---|---|
| Vecuronium Bromide | Active comparator | Patients who will be performed general anesthesia and tracheal intubation. Vecuronium will be used during surgery and tracheal extubation is scheduled when surgery is over. Receives: Drug: Vecuronium Bromide |
| cisatracurium | Active comparator | Patients who will be performed general anesthesia and tracheal intubation. Cisatracurium will be used during surgery and tracheal extubation is scheduled when surgery is over. Receives: Drug: Cisatracurium |
| rocuronium | Active comparator | Patients who will be performed general anesthesia and tracheal intubation. Rocuronium will be used during surgery and tracheal extubation is scheduled when surgery is over. Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of TOFr<0.9
Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately.
Measured: From tracheal extubation to 1 minute after extubation
Secondary outcomes (3)
Incidence of TOFr<0.9
When patients arrive at PACU(an expected average of 15 minutes after surgery is over), monitor the neuromuscular transmission function (TOF ratio) immediately
Measured: One minute after arriving at PACU
Incidence of TOFr<0.7
Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately.
Measured: From tracheal extubation to 1 minute after extubation
Incidence of TOFr<0.7
When patients arrive at PACU(an expected average of 15 minutes after surgery is over), monitor the neuromuscular transmission function (TOF ratio) immediately
Measured: One minute after arriving at PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Perioperative/Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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, Care provider
- Enrolment
- 6,090 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, RenJi Hospital, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Guangzhou Medical University, West China Hospital, Eastern Hepatobiliary Surgery Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhujiang Hospital, Chinese PLA General Hospital, First Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, Tianjin Medical University General Hospital, Xiangya Hospital of Central South University, Central South University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, First Affiliated Hospital of Xinjiang Medical University, Peking Union Medical College Hospital, First Affiliated Hospital of Zhejiang University, China Medical University Hospital, Hebei Medical University Fourth Hospital, Tongji Hospital
- Responsible party
- Principal investigator, Xinmin Wu, Peking University First Hospital
- Investigators
- Xinmin Wu, Doctor, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690338
- Sponsor's protocol ID
- CSA-NMB-001
- Status last verified
- May 2013
- First submitted
- 4 Sep 2012
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cammu G, De Witte J, De Veylder J, Byttebier G, Vandeput D, Foubert L, Vandenbroucke G, Deloof T. Postoperative residual paralysis in outpatients versus inpatients. Anesth Analg. 2006 Feb;102(2):426-9. doi: 10.1213/01.ane.0000195543.61123.1f.
PubMed 16428537Naguib M, Kopman AF, Lien CA, Hunter JM, Lopez A, Brull SJ. A survey of current management of neuromuscular block in the United States and Europe. Anesth Analg. 2010 Jul;111(1):110-9. doi: 10.1213/ANE.0b013e3181c07428. Epub 2009 Nov 12.
PubMed 19910616Naguib M, Kopman AF, Ensor JE. Neuromuscular monitoring and postoperative residual curarisation: a meta-analysis. Br J Anaesth. 2007 Mar;98(3):302-16. doi: 10.1093/bja/ael386.
PubMed 17307778Hayes AH, Mirakhur RK, Breslin DS, Reid JE, McCourt KC. Postoperative residual block after intermediate-acting neuromuscular blocking drugs. Anaesthesia. 2001 Apr;56(4):312-8. doi: 10.1046/j.1365-2044.2001.01921.x.
PubMed 11284816Baillard C, Clec'h C, Catineau J, Salhi F, Gehan G, Cupa M, Samama CM. Postoperative residual neuromuscular block: a survey of management. Br J Anaesth. 2005 Nov;95(5):622-6. doi: 10.1093/bja/aei240. Epub 2005 Sep 23.
PubMed 16183681Cammu G, de Baerdemaeker L, den Blauwen N, de Mey JC, Struys M, Mortier E. Postoperative residual curarization with cisatracurium and rocuronium infusions. Eur J Anaesthesiol. 2002 Feb;19(2):129-34. doi: 10.1017/s0265021502000236.
PubMed 11999596Baillard C, Gehan G, Reboul-Marty J, Larmignat P, Samama CM, Cupa M. Residual curarization in the recovery room after vecuronium. Br J Anaesth. 2000 Mar;84(3):394-5. doi: 10.1093/oxfordjournals.bja.a013445.
PubMed 10793602Murphy GS, Szokol JW, Marymont JH, Franklin M, Avram MJ, Vender JS. Residual paralysis at the time of tracheal extubation. Anesth Analg. 2005 Jun;100(6):1840-1845. doi: 10.1213/01.ANE.0000151159.55655.CB.
PubMed 15920224Debaene B, Plaud B, Dilly MP, Donati F. Residual paralysis in the PACU after a single intubating dose of nondepolarizing muscle relaxant with an intermediate duration of action. Anesthesiology. 2003 May;98(5):1042-8. doi: 10.1097/00000542-200305000-00004.
PubMed 12717123Srivastava A, Hunter JM. Reversal of neuromuscular block. Br J Anaesth. 2009 Jul;103(1):115-29. doi: 10.1093/bja/aep093. Epub 2009 May 24.
PubMed 19468024
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Perspective, Multicentre, Randomized，Blind Study of Residual Curarization Incidence in China
- ClinicalTrials.gov ID
- NCT01690338
- Acronym / sponsor ID
- CSA-NMB-001
- Keywords
- TOFr (train of four ratio), airway extubation, PACU (postanesthesia care unit), PORC (postoperative residual curarization)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,090 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, RenJi Hospital, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Guangzhou Medical University, West China Hospital, Eastern Hepatobiliary Surgery Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhujiang Hospital, Chinese PLA General Hospital, First Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, Tianjin Medical University General Hospital, Xiangya Hospital of Central South University, Central South University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, First Affiliated Hospital of Xinjiang Medical University, Peking Union Medical College Hospital, First Affiliated Hospital of Zhejiang University, China Medical University Hospital, Hebei Medical University Fourth Hospital, Tongji Hospital
- Study start
- Oct 2012
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 21 Sep 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.
The purpose of this study is to determine the incidence of residual curarization in PACU and relevant risk factors.
Detailed description
In the last twenty years, residual curarization in PACU (Post Anesthesia Care Unit) has become a common problem in clinical practice and poses high risk to patients. The residual curarization incidence of Neuromuscular blocking agents (NMBA) varies very much between different studies. These differences indicates the necessity of further study. In China, there is no common view of the harmfulness of residual curarization and its complications. The consensus on the necessity of neuromuscular transmission monitoring and neuromuscular blockade antagonist has not been reached yet. There is also no similar large-scale survey in China. In this case, the investigators conduct this large scale multicentre study, which is designed to learn the incidence of residual curarization and its complications. Further analysis of risk factors will also been made. All these efforts are hoped to fill the data gap and provide reliable evidences for rational use of NMBA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vecuronium Bromide | Active comparator | Drug: Vecuronium BromidePatients who will be performed general anesthesia and tracheal intubation. Vecuronium will be used during surgery and tracheal extubation is scheduled when surgery is over. |
| cisatracurium | Active comparator | Drug: CisatracuriumPatients who will be performed general anesthesia and tracheal intubation. Cisatracurium will be used during surgery and tracheal extubation is scheduled when surgery is over. |
| rocuronium | Active comparator | Drug: RocuroniumPatients who will be performed general anesthesia and tracheal intubation. Rocuronium will be used during surgery and tracheal extubation is scheduled when surgery is over. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 or older
- Nondepolarized NMBA will be given during surgery and tracheal extubation will be performed after surgery
- Willing to comply with all study procedures and provide signed and dated informed consent
Key exclusion criteria (5 listed)
- Allergic reaction to gel electrode
- Neuromuscular disorders and hepatic or renal dysfunction
- Scheduled to receive mechanical ventilation therapy
- Involved in other clinical trials
- Body position and surgical procedure affecting TOF-Watch SX normal function
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 |
|---|---|---|
| Vecuronium BromideAlso: NorcuronAdministrative protocol of Vecuronium Bromide is determined by each caregiver's clinical experience. | Drug | Vecuronium Bromide |
| RocuroniumAlso: EsmeronAdministrative protocol of rocuronium is determined by each caregiver's clinical experience. | Drug | rocuronium |
| CisatracuriumAlso: NimbexAdministrative protocol of cisatracurium is determined by each caregiver's clinical experience | Drug | cisatracurium |
Primary outcome
incidence of TOFr<0.9
Time frame: From tracheal extubation to 1 minute after extubation
Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately.
3 secondary outcomes
Incidence of TOFr<0.9
Time frame: One minute after arriving at PACU
Incidence of TOFr<0.7
Time frame: From tracheal extubation to 1 minute after extubation
Incidence of TOFr<0.7
Time frame: One minute after arriving at PACU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
- Background: PubMed 16428537Cammu G, De Witte J, De Veylder J, Byttebier G, Vandeput D, Foubert L, Vandenbroucke G, Deloof T. Postoperative residual paralysis in outpatients versus inpatients. Anesth Analg. 2006 Feb;102(2):426-9. doi: 10.1213/01.ane.0000195543.61123.1f.
- Background: PubMed 19910616Naguib M, Kopman AF, Lien CA, Hunter JM, Lopez A, Brull SJ. A survey of current management of neuromuscular block in the United States and Europe. Anesth Analg. 2010 Jul;111(1):110-9. doi: 10.1213/ANE.0b013e3181c07428. Epub 2009 Nov 12.
- Background: PubMed 17307778Naguib M, Kopman AF, Ensor JE. Neuromuscular monitoring and postoperative residual curarisation: a meta-analysis. Br J Anaesth. 2007 Mar;98(3):302-16. doi: 10.1093/bja/ael386.
- Background: PubMed 11284816Hayes AH, Mirakhur RK, Breslin DS, Reid JE, McCourt KC. Postoperative residual block after intermediate-acting neuromuscular blocking drugs. Anaesthesia. 2001 Apr;56(4):312-8. doi: 10.1046/j.1365-2044.2001.01921.x.
- Background: PubMed 16183681Baillard C, Clec'h C, Catineau J, Salhi F, Gehan G, Cupa M, Samama CM. Postoperative residual neuromuscular block: a survey of management. Br J Anaesth. 2005 Nov;95(5):622-6. doi: 10.1093/bja/aei240. Epub 2005 Sep 23.
- Background: PubMed 11999596Cammu G, de Baerdemaeker L, den Blauwen N, de Mey JC, Struys M, Mortier E. Postoperative residual curarization with cisatracurium and rocuronium infusions. Eur J Anaesthesiol. 2002 Feb;19(2):129-34. doi: 10.1017/s0265021502000236.
- Background: PubMed 10793602Baillard C, Gehan G, Reboul-Marty J, Larmignat P, Samama CM, Cupa M. Residual curarization in the recovery room after vecuronium. Br J Anaesth. 2000 Mar;84(3):394-5. doi: 10.1093/oxfordjournals.bja.a013445.
- Background: PubMed 15920224Murphy GS, Szokol JW, Marymont JH, Franklin M, Avram MJ, Vender JS. Residual paralysis at the time of tracheal extubation. Anesth Analg. 2005 Jun;100(6):1840-1845. doi: 10.1213/01.ANE.0000151159.55655.CB.
- Background: PubMed 12717123Debaene B, Plaud B, Dilly MP, Donati F. Residual paralysis in the PACU after a single intubating dose of nondepolarizing muscle relaxant with an intermediate duration of action. Anesthesiology. 2003 May;98(5):1042-8. doi: 10.1097/00000542-200305000-00004.
- Background: PubMed 19468024Srivastava A, Hunter JM. Reversal of neuromuscular block. Br J Anaesth. 2009 Jul;103(1):115-29. doi: 10.1093/bja/aep093. Epub 2009 May 24.
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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.
Xinmin Wu, Doctor principal investigator
Peking University First Hospital
22 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 Vecuronium Bromide, Rocuronium and Cisatracurium in people with Perioperative/Postoperative Complications and PORC (Postoperative Residual Curarization), run by Peking University First Hospital at 22 sites in China.
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 3 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 24 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinmin Wu, Doctor (+86 13910616740, xmwu2784@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of TOFr<0.9 (time frame: From tracheal extubation to 1 minute after extubation). 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 NCT01690338, which also lists 10 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 24 May 2013.