Post-thoracotomy Pain SyndromePhase 4NCT02619513
Effects of Dexmedetomidine Used in Continuous Thoracic Paravertebral Blocks
A Phase 4 study testing Dexmedetomidine, Ropivacaine and Mindray M7 series in people with Post-thoracotomy Pain Syndrome, run by Weifeng Tu at 1 site in China.
Trial summary
The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive analgesic, used in ultrasound-guided continuous thoracic paravertebral blocks for Post-thoracotomy Pain Syndrome(PTPS). Read more about this study
- Who is it for?
- Ages 19 to 76 years
- Conditions the study is for
- Post-thoracotomy Pain Syndrome
- What is being tested?
- Dexmedetomidine, Ropivacaine and Mindray M7 series
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Sep 2015
- 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 19 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Ⅰ～Ⅲ patient undergoing thoracotomy;
- Written informed consent from the patient or the relatives of the participating patient.
- BMI:18～25kg/m2
Who cannot join
- Mental illness;
- Epidural anesthesia or thoracic paravertebral blocks contraindicated;
- People who have Slow-type arrhythmias or hypotension;
- People who have lung infection or sleep apnea syndrome;
- People who have chronic renal failure;
- Alcohol or drug abuse;
- Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug;
- Local anesthetics allergy;
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology，Guangzhou Military Region General Hospital
Guangzhou, Guangdong, 510010
About this study
Official title: Effects of Dexmedetomidine as an Adjunctive Analgesic Used in Continuous Thoracic Paravertebral Blocks for Post-thoracotomy Pain Syndrome
The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive analgesic, used in ultrasound-guided continuous thoracic paravertebral blocks for Post-thoracotomy Pain Syndrome(PTPS).
Read the detailed description
Thoracic surgical procedures are among the most painful operations, and their outcomes are affected adversely by postoperative discomfort. Post-thoracotomy pain syndrome (PTPS) is a well-recognized complication of thoracotomy. Post-thoracotomy pain control improves patient satisfaction and decreases postoperative complication morbidity. Epidural analgesia used to be considered as the best method of pain relief after major surgery despite its side-effects, which includes hypotension, respiratory depression, incomplete or failed block, etc. Recently, paravertebral block is an alternative technique that may offer a comparable analgesic effect and a better side-effect profile for post-thoracotomy pain. Dexmedetomidine(DEX) is a Food and Drug Administration-approved, parenteral, selective α2-agonist that induces anxiolytic and analgesia without respiratory depression. It could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects . Current studies with regard to the effectiveness of DEX as an adjunctive medicine, used in ultrasound-guided continuous thoracic paravertebral blocks for PTPS. The mechanical withdrawal threshold and VAS scores are recorded. The consumption of opioid and general anesthetics during perioperative period are also recorded. To compare the incidence rates of side effects, such as nausea, vomiting, dizziness, hypotension and bradyarrhythmia in the first 3 days after operation among the groups.Also,to measure and compare the level of inflammatory factor in different group.A questionnaire is adopted to investigate whether there are chronic pain symptoms happen at 6 months after the operation which aim to PTPS.
- Conditions
- Post-thoracotomy Pain Syndrome
- Being tested
- Dexmedetomidine, Ropivacaine, Mindray M7 series
- Keywords
- Paravertebral Blocks, Dexmedetomidine, Analgesia, Inflammatory response, Thoracotomy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Group GTD received thoracic continuous paravertebral nerve block with dexmedetomidine (0.5μg/kg) added to ropivacaine before anesthesia induction, and used continuous thoracic paravertebral nerve block patient-controlled analgesia(with dexmedetomidine 100μg）.
RopivacaineDrug
Group GE\GT\GTD respectively received continuous nerve blocks and postoperative analgesia combined with ropivacaine.
Mindray M7 seriesDevice
Ultrasound real-time guidance have been used in continuous thoracic paravertebral blocks in group GT and group GTD.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia group(Group GA) | No intervention | Group GA received general anesthesia only and intravenous analgesia pump. |
| TEB group(Group GE) | Experimental | Group GE received continuous thoracic epidural block(TEB) combined with general anesthesia and postoperative continuous thoracic epidural analgesia, and only added ropivacaine in PVB as an postoperative adjuvant. Receives: Drug: Ropivacaine |
| PVB without DEX group (Group GT) | Experimental | Group GT received ultrasound-guided(Mindray M7 series) continuous thoracic paravertebral nerve block(PVB) combined with general anesthesia and continuous thoracic paravertebral nerve block patient-controlled analgesia, and only added ropivacaine in PVB as an postoperative adjuvant. Receives: Drug: Ropivacaine; Device: Mindray M7 series |
| PVB with DEX group(Group GTD) | Experimental | Group GTD received ultrasound-guided(Mindray M7 series) continuous thoracic paravertebral nerve block combined with general anesthesia and continuous thoracic paravertebral nerve block patient-controlled analgesia,but with dexmedetomidine 0.5μg/kg added to ropivacaine in PVB as an adjuvant. Receives: Drug: Dexmedetomidine; Drug: Ropivacaine; Device: Mindray M7 series |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline mechanical withdrawal threshold(unit: g) of patients without treatment-related events.
Baseline quantization degree of algesia without treatment-related events before receiving thoracotomy measured by Electric Von Frey 2391, and the testing position is located in the intercostal skin at the level of operation incisions, which about 2cm away from the incision.
Measured: the day before the operation
The change of mechanical withdrawal threshold(unit: g) of patients with different treatment-related events in the following one week after thoracotomy.
To show the changing trend of quantization degree of hyperalgesia and allodynia with different treatment-related events after receiving thoracotomy measured by Electric Von Frey 2391, and the testing position is located in the intercostal skin at the level of operation incisions, which about 2cm away from the incision.
Measured: 12, 24, 48, 72h and 1w after the operation
The change of Interleukin-6(IL-6) of patients with different treatment-related events during the perioperative period.
The changing trend of plasma IL- 6 in venous blood of patients with different treatment-related events during the perioperative period. And the blood time is in the morning before patients feed at each expected testing time point.
Measured: pre-operation and 6, 24, 72h after the operation
The change of Interleukin-10(IL-10) of patients with different treatment-related events during the perioperative period.
The changing trend of plasma IL-10 in venous blood of patients with different treatment-related events during the perioperative period. And the blood time is in the morning before patients feed at each expected testing time point.
Measured: pre-operation and 6, 24, 72h after the operation
The change of tumor necrosis factor-α(TNF-α) of patients with different treatment-related events during the perioperative period.
The changing trend of TNF-α in venous blood of patients with different treatment-related events during the perioperative period. And the blood time is in the morning before patients feed at each expected testing time point.
Measured: pre-operation and 6, 24, 72h after the operation
Secondary outcomes (7)
The change of visual analogue scale(VAS) of patients with different treatment-related events in the following one week after thoracotomy.
To show the changing trend of visual analogue scale(VAS) in order to subjectively speculate the degree of hyperalgesia and allodynia with different treatment-related events after receiving thoracotomy, and the testing position is located in the intercostal skin at the level of operation incisions, which about 2cm away from the incision.
Measured: 12, 24, 48, 72h and 1w after the operation
The intraoperative consumption of opioids.
The consumption of opioid(remifentanil and sufentanil) during the operation are recorded(the consumption of sufentanil was converted to the consumption of remifentanil producing the equivalent effect by 1:10,unit:mg).
Measured: From the beginning to the end of the anesthesia procedure.
The postoperative consumption of opioids.
If insufficient analgesia happens(resting VAS scores>4), than use dezocine intravenously as additional analgesia(a single dose 5-20mg, no more than 120mg per day). The consumption of opioid(dezocine) in the following 3 days after the operation are recorded(unit:mg).
Measured: in the first 3 days after operation
The change of mean arterial pressure (MAP) of the patients when receiving the thoracotomy.
To show the changing trend of hemodynamics with different treatment-related events when receiving thoracotomy.
Measured: the key time have been distributed into five parts: when the patient was brought to the operation room (T0), 15 mins after paravertebral administration (T1), after intubation (T2), after skin incision (T3), before extubation (T4)
The change of heart rate(HR) of the patients when receiving the thoracotomy.
To show the changing trend of hemodynamics with different treatment-related events when receiving thoracotomy.
Measured: the key time have been distributed into five parts: when the patient was brought to the operation room (T0), 15 mins after paravertebral administration (T1), after intubation (T2), after skin incision (T3), before extubation (T4)
The incidence rates of side effects.
To compare the incidence rates of side effects, such as nausea, vomiting, dizziness, hypotension and bradyarrhythmia in the first 3 days after operation.
Measured: in the first 3 days after operation
A questionnaire related to postoperation chronic for the patients who have receiving thoracotomy.
A questionnaire is adopted to investigate whether there are chronic pain symptoms happen at 6 months after the operation which aim to PTPS.
Measured: at 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startDec 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-thoracotomy Pain SyndromeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weifeng Tu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weifeng Tu, Guangzhou General Hospital of Guangzhou Military Command
- Investigators
- Jie Peng, PhD, Principal investigator, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619513
- Sponsor's protocol ID
- Dexmedetomidine TPVB
- Status last verified
- Nov 2015
- First submitted
- 22 Sep 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ding X, Jin S, Niu X, Ren H, Fu S, Li Q. A comparison of the analgesia efficacy and side effects of paravertebral compared with epidural blockade for thoracotomy: an updated meta-analysis. PLoS One. 2014 May 5;9(5):e96233. doi: 10.1371/journal.pone.0096233. eCollection 2014.
PubMed 24797238Komatsu T, Sowa T, Takahashi K, Fujinaga T. Paravertebral block as a promising analgesic modality for managing post-thoracotomy pain. Ann Thorac Cardiovasc Surg. 2014;20(2):113-6. doi: 10.5761/atcs.oa.12.01999. Epub 2013 Feb 28.
PubMed 23445804Kimura M, Saito S, Obata H. Dexmedetomidine decreases hyperalgesia in neuropathic pain by increasing acetylcholine in the spinal cord. Neurosci Lett. 2012 Oct 31;529(1):70-4. doi: 10.1016/j.neulet.2012.08.008. Epub 2012 Aug 16.
PubMed 22917606El-Morsy GZ, El-Deeb A, El-Desouky T, Elsharkawy AA, Elgamal MA. Can thoracic paravertebral block replace thoracic epidural block in pediatric cardiac surgery? A randomized blinded study. Ann Card Anaesth. 2012 Oct-Dec;15(4):259-63. doi: 10.4103/0971-9784.101848.
PubMed 23041682
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine as an Adjunctive Analgesic Used in Continuous Thoracic Paravertebral Blocks for Post-thoracotomy Pain Syndrome
- ClinicalTrials.gov ID
- NCT02619513
- Acronym / sponsor ID
- Dexmedetomidine TPVB
- Conditions
- Post-thoracotomy Pain Syndrome
- Keywords
- Paravertebral Blocks, Dexmedetomidine, Analgesia, Inflammatory response, Thoracotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Weifeng TuUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 2 Dec 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.
The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive analgesic, used in ultrasound-guided continuous thoracic paravertebral blocks for Post-thoracotomy Pain Syndrome(PTPS).
Detailed description
Thoracic surgical procedures are among the most painful operations, and their outcomes are affected adversely by postoperative discomfort. Post-thoracotomy pain syndrome (PTPS) is a well-recognized complication of thoracotomy. Post-thoracotomy pain control improves patient satisfaction and decreases postoperative complication morbidity. Epidural analgesia used to be considered as the best method of pain relief after major surgery despite its side-effects, which includes hypotension, respiratory depression, incomplete or failed block, etc. Recently, paravertebral block is an alternative technique that may offer a comparable analgesic effect and a better side-effect profile for post-thoracotomy pain. Dexmedetomidine(DEX) is a Food and Drug Administration-approved, parenteral, selective α2-agonist that induces anxiolytic and analgesia without respiratory depression. It could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects . Current studies with regard to the effectiveness of DEX as an adjunctive medicine, used in ultrasound-guided continuous thoracic paravertebral blocks for PTPS. The mechanical withdrawal threshold and VAS scores are recorded. The consumption of opioid and general anesthetics during perioperative period are also recorded. To compare the incidence rates of side effects, such as nausea, vomiting, dizziness, hypotension and bradyarrhythmia in the first 3 days after operation among the groups.Also,to measure and compare the level of inflammatory factor in different group.A questionnaire is adopted to investigate whether there are chronic pain symptoms happen at 6 months after the operation which aim to PTPS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| General anesthesia group(Group GA) | No intervention | –Group GA received general anesthesia only and intravenous analgesia pump. |
| TEB group(Group GE) | Experimental | Drug: RopivacaineGroup GE received continuous thoracic epidural block(TEB) combined with general anesthesia and postoperative continuous thoracic epidural analgesia, and only added ropivacaine in PVB as an postoperative adjuvant. |
| PVB without DEX group (Group GT) | Experimental | Drug: Ropivacaine, Device: Mindray M7 seriesGroup GT received ultrasound-guided(Mindray M7 series) continuous thoracic paravertebral nerve block(PVB) combined with general anesthesia and continuous thoracic paravertebral nerve block patient-controlled analgesia, and only added ropivacaine in PVB as an postoperative adjuvant. |
| PVB with DEX group(Group GTD) | Experimental | Drug: Dexmedetomidine, Drug: Ropivacaine, Device: Mindray M7 seriesGroup GTD received ultrasound-guided(Mindray M7 series) continuous thoracic paravertebral nerve block combined with general anesthesia and continuous thoracic paravertebral nerve block patient-controlled analgesia,but with dexmedetomidine 0.5μg/kg added to ropivacaine in PVB as an adjuvant. |
Who may qualify
- Ages
- 19 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA Ⅰ～Ⅲ patient undergoing thoracotomy;
- Written informed consent from the patient or the relatives of the participating patient.
- BMI:18～25kg/m2
Key exclusion criteria (8 listed)
- Mental illness;
- Epidural anesthesia or thoracic paravertebral blocks contraindicated;
- People who have Slow-type arrhythmias or hypotension;
- People who have lung infection or sleep apnea syndrome;
- People who have chronic renal failure;
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 |
|---|---|---|
| DexmedetomidineGroup GTD received thoracic continuous paravertebral nerve block with dexmedetomidine (0.5μg/kg) added to ropivacaine before anesthesia induction, and used continuous thoracic paravertebral nerve block patient-controlled analgesia(with dexmedetomidine 100μg）. | Drug | PVB with DEX group(Group GTD) |
| RopivacaineGroup GE\GT\GTD respectively received continuous nerve blocks and postoperative analgesia combined with ropivacaine. | Drug | PVB with DEX group(Group GTD), PVB without DEX group (Group GT), TEB group(Group GE) |
| Mindray M7 seriesUltrasound real-time guidance have been used in continuous thoracic paravertebral blocks in group GT and group GTD. | Device | PVB with DEX group(Group GTD), PVB without DEX group (Group GT) |
Primary outcome
Baseline mechanical withdrawal threshold(unit: g) of patients without treatment-related events.
Time frame: the day before the operation
Baseline quantization degree of algesia without treatment-related events before receiving thoracotomy measured by Electric Von Frey 2391, and the testing position is located in the intercostal skin at the level of operation incisions, which about 2cm away from the incision.
The change of mechanical withdrawal threshold(unit: g) of patients with different treatment-related events in the following one week after thoracotomy.
Time frame: 12, 24, 48, 72h and 1w after the operation
To show the changing trend of quantization degree of hyperalgesia and allodynia with different treatment-related events after receiving thoracotomy measured by Electric Von Frey 2391, and the testing position is located in the intercostal skin at the level of operation incisions, which about 2cm away from the incision.
The change of Interleukin-6(IL-6) of patients with different treatment-related events during the perioperative period.
Time frame: pre-operation and 6, 24, 72h after the operation
The changing trend of plasma IL- 6 in venous blood of patients with different treatment-related events during the perioperative period. And the blood time is in the morning before patients feed at each expected testing time point.
The change of Interleukin-10(IL-10) of patients with different treatment-related events during the perioperative period.
Time frame: pre-operation and 6, 24, 72h after the operation
The changing trend of plasma IL-10 in venous blood of patients with different treatment-related events during the perioperative period. And the blood time is in the morning before patients feed at each expected testing time point.
The change of tumor necrosis factor-α(TNF-α) of patients with different treatment-related events during the perioperative period.
Time frame: pre-operation and 6, 24, 72h after the operation
The changing trend of TNF-α in venous blood of patients with different treatment-related events during the perioperative period. And the blood time is in the morning before patients feed at each expected testing time point.
7 secondary outcomes
The change of visual analogue scale(VAS) of patients with different treatment-related events in the following one week after thoracotomy.
Time frame: 12, 24, 48, 72h and 1w after the operation
The intraoperative consumption of opioids.
Time frame: From the beginning to the end of the anesthesia procedure.
The postoperative consumption of opioids.
Time frame: in the first 3 days after operation
The change of mean arterial pressure (MAP) of the patients when receiving the thoracotomy.
Time frame: the key time have been distributed into five parts: when the patient was brought to the operation room (T0), 15 mins after paravertebral administration (T1), after intubation (T2), after skin incision (T3), before extubation (T4)
The change of heart rate(HR) of the patients when receiving the thoracotomy.
Time frame: the key time have been distributed into five parts: when the patient was brought to the operation room (T0), 15 mins after paravertebral administration (T1), after intubation (T2), after skin incision (T3), before extubation (T4)
The incidence rates of side effects.
Time frame: in the first 3 days after operation
A questionnaire related to postoperation chronic for the patients who have receiving thoracotomy.
Time frame: at 6 months after operation
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 2 Dec 2015.
- Background: PubMed 24797238Ding X, Jin S, Niu X, Ren H, Fu S, Li Q. A comparison of the analgesia efficacy and side effects of paravertebral compared with epidural blockade for thoracotomy: an updated meta-analysis. PLoS One. 2014 May 5;9(5):e96233. doi: 10.1371/journal.pone.0096233. eCollection 2014.
- Background: PubMed 23445804Komatsu T, Sowa T, Takahashi K, Fujinaga T. Paravertebral block as a promising analgesic modality for managing post-thoracotomy pain. Ann Thorac Cardiovasc Surg. 2014;20(2):113-6. doi: 10.5761/atcs.oa.12.01999. Epub 2013 Feb 28.
- Background: PubMed 22917606Kimura M, Saito S, Obata H. Dexmedetomidine decreases hyperalgesia in neuropathic pain by increasing acetylcholine in the spinal cord. Neurosci Lett. 2012 Oct 31;529(1):70-4. doi: 10.1016/j.neulet.2012.08.008. Epub 2012 Aug 16.
- Background: PubMed 23041682El-Morsy GZ, El-Deeb A, El-Desouky T, Elsharkawy AA, Elgamal MA. Can thoracic paravertebral block replace thoracic epidural block in pediatric cardiac surgery? A randomized blinded study. Ann Card Anaesth. 2012 Oct-Dec;15(4):259-63. doi: 10.4103/0971-9784.101848.
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.
Jie Peng, PhD principal investigator
Guangzhou General Hospital of Guangzhou Military Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Ropivacaine and Mindray M7 series in people with Post-thoracotomy Pain Syndrome, run by Weifeng Tu at 1 site 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 8 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 2 Dec 2015. 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 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?
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?
Baseline mechanical withdrawal threshold(unit: g) of patients without treatment-related events. (time frame: the day before the operation). The study lists 5 primary outcomes in all. 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 NCT02619513, which also lists 4 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 2 Dec 2015.