PainNCT01839461
Pharmacogenetic Morphine Spine Study
An observational study of Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to identify factors and genes (the DNA material that determines the makeup of the human body) that may be associated with how children cope with pain and respond to pain medication. Morphine is a pain medication commonly prescribed after this surgery during the hospital stay. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Pain
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to 2 Apr 2019
- Phase
- Observational
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children ages 10 to 18, inclusive, years scheduled for spinal surgical procedures.
Who may be able to join
- Children aged 10 to 18, inclusive, years of age
- Diagnosis of Idiopathic scoliosis, kyphosis and/or kyphoscoliosis
- Scheduled for spine fusion
Who cannot join
- Known hypersensitivity to morphine
- Patients on chronic pain medication.
- Pregnant or breastfeeding females.
- Children with a history of or active renal or liver disease.
- Concomitant use of medication known to induce or inhibit CYP2D6 activity including paroxetine, fluoxetine, cimetidine, duloxetine or methadone.
- Non-English speaking patients.
- Developmental delay.
- Children who have problems with pupil or pupillary reaction due to disease (such as amyloidosis, bilateral Horner's syndrome, familial dysautonomia, other major neurological disorders) or preoperative medications influencing pupillary size (anti-cholinergic, narcotic medications such as codeine in cough syrup) will be recruited but pupillometry will be deferred.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Personalizing Perioperative Morphine Analgesia for Adolescents Undergoing Major Spine Surgeries
The purpose of this research study is to identify factors and genes (the DNA material that determines the makeup of the human body) that may be associated with how children cope with pain and respond to pain medication. Morphine is a pain medication commonly prescribed after this surgery during the hospital stay. The investigators want to study factors that may be associated with morphine requirement after surgery and side-effects from morphine. They will use pharmacometric models to identify dosing guidelines and factors associated with individual variability in metabolism and efficacy/safety of morphine. They will also study psychological, genetic and epigenetic factors associated with acute and chronic post-surgical pain after spine surgery. The investigators expect that the information obtained in this research study will help to develop effective, safer, and tailored treatment options in the future.
Read the detailed description
Safe and effective analgesia is an important unmet medical need in children. Despite efforts to promote non-pharmacologic interventions, drug treatment remains the standard of care for children experiencing severe pain following surgery. Inadequate pain relief after invasive surgery, and side effects from analgesics such as morphine occur frequently in up to 50% of children. A study of patient-controlled analgesia morphine use after spine surgery in adolescents observed a 45% incidence of postoperative nausea and vomiting 15% incidence of pruritis and 7% incidence of respiratory depression. Among the drugs available, the opioids, specifically morphine is the most commonly employed. Morphine has a narrow therapeutic index, with the most fatal toxicity being respiratory depression. For morphine, like most opioids, there is a fine balance in dosing regimen between optimal pain control and safety in terms of decreasing morphine's respiratory depressant/ sedative side effects. Inadequate pain relief and analgesic side effects have major clinical, behavioral and economic consequences. Neither evidence-based dosing guidelines nor rigorous documentation of therapeutic benefit for morphine has been ascertained in the pediatric patient population. Despite aggressive pain management after spine surgery, findings showed that neither children's pain nor their analgesic use diminished significantly over time. As such, there is a critical knowledge gap in the medical literature that significantly impacts the pediatric pain management. In recognition of this therapeutic challenge the investigators plan to evaluate the determinants of inter-individual differences in opioid analgesic responsiveness and adverse effects in children. Adolescents following spine surgery have a great variability in morphine requirements with greater use as they became older. Analgesic dosing is dependent on appreciation of the interplay between pharmacokinetics, pharmacodynamics and therapeutics. These factors are often poorly understood, where the effective control of procedural pain for example, remains problematic. Suitable pharmacological alternatives to opioid treatment for moderate to severe pain in children after surgery are limited and consequently there is a need for a critical evaluation of the existing opioids and research reports.
Recently a number of small studies have shown the association of single nucleotide polymorphism in genes in the pain pathway, with altered pain response to a stimulus or altered response to opioids following a painful procedure. Age, gender, cultural influences, anxiety, type of surgical procedure and genetic factors can all influence the response. By extending follow up of patients to years after surgery, the aims were amended to include evaluation of chronic post-surgical outcomes.
We will be collecting data on pain scores, opioid effects, psychological questionnaires, blood samples and pupillometry data.
- Conditions
- Pain
- Keywords
- Pharmacogenetics, postoperative, pediatric, opioid, perioperative, respiratory depression, chronic pain
- Medical subject headings
- Pain, Respiratory Insufficiency, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate postoperative pain scores in the recovery room
Pain score will be measured using standard and validated scales, Numeric rating scale (NRS 0 - 10). This scale has been widely validated and discriminates mild, moderate and severe pain
Measured: 1 day ( Recovery room)
Secondary outcomes (4)
postoperative intravenous morphine requirement
Pain score will be measured using standard and validated scales, Numeric rating scale (NRS 0 - 10). This scale has been widely validated and discriminates mild, moderate and severe pain.
Measured: First 48 hours after surgery
Chronic pain pre-operatively
Participants will complete questionnaires regarding pain since surgery was completed
Measured: Pre-operative
Chronic pain post-operatively
Participants will complete questionnaires regarding pain since surgery was completed
Measured: 2 - 6 months post-operative
Chronic pain post-operatively
Participants will complete questionnaires regarding pain since surgery was completed
Measured: 10 - 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startJul 2009
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (73)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vidya Chidambaran, MD, Principal investigator, Cincinnati Childrens Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839461
- Sponsor's protocol ID
- 2009-0973
- Status last verified
- Apr 2019
- First submitted
- 22 Apr 2013
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Beaulieu P, Cyrenne L, Mathews S, Villeneuve E, Vischoff D. Patient-controlled analgesia after spinal fusion for idiopathic scoliosis. Int Orthop. 1996;20(5):295-9. doi: 10.1007/s002640050081.
PubMed 8930721Rahim-Williams FB, Riley JL 3rd, Herrera D, Campbell CM, Hastie BA, Fillingim RB. Ethnic identity predicts experimental pain sensitivity in African Americans and Hispanics. Pain. 2007 May;129(1-2):177-84. doi: 10.1016/j.pain.2006.12.016. Epub 2007 Feb 12.
PubMed 17296267Rakvag TT, Klepstad P, Baar C, Kvam TM, Dale O, Kaasa S, Krokan HE, Skorpen F. The Val158Met polymorphism of the human catechol-O-methyltransferase (COMT) gene may influence morphine requirements in cancer pain patients. Pain. 2005 Jul;116(1-2):73-8. doi: 10.1016/j.pain.2005.03.032.
PubMed 15927391Nackley AG, Tan KS, Fecho K, Flood P, Diatchenko L, Maixner W. Catechol-O-methyltransferase inhibition increases pain sensitivity through activation of both beta2- and beta3-adrenergic receptors. Pain. 2007 Apr;128(3):199-208. doi: 10.1016/j.pain.2006.09.022. Epub 2006 Nov 7.
PubMed 17084978Diatchenko L, Nackley AG, Slade GD, Bhalang K, Belfer I, Max MB, Goldman D, Maixner W. Catechol-O-methyltransferase gene polymorphisms are associated with multiple pain-evoking stimuli. Pain. 2006 Dec 5;125(3):216-224. doi: 10.1016/j.pain.2006.05.024. Epub 2006 Jul 11.
PubMed 16837133Diatchenko L, Slade GD, Nackley AG, Bhalang K, Sigurdsson A, Belfer I, Goldman D, Xu K, Shabalina SA, Shagin D, Max MB, Makarov SS, Maixner W. Genetic basis for individual variations in pain perception and the development of a chronic pain condition. Hum Mol Genet. 2005 Jan 1;14(1):135-43. doi: 10.1093/hmg/ddi013. Epub 2004 Nov 10.
PubMed 15537663Zubieta JK, Heitzeg MM, Smith YR, Bueller JA, Xu K, Xu Y, Koeppe RA, Stohler CS, Goldman D. COMT val158met genotype affects mu-opioid neurotransmitter responses to a pain stressor. Science. 2003 Feb 21;299(5610):1240-3. doi: 10.1126/science.1078546.
PubMed 12595695Oertel BG, Schmidt R, Schneider A, Geisslinger G, Lotsch J. The mu-opioid receptor gene polymorphism 118A>G depletes alfentanil-induced analgesia and protects against respiratory depression in homozygous carriers. Pharmacogenet Genomics. 2006 Sep;16(9):625-36. doi: 10.1097/01.fpc.0000220566.90466.a2.
PubMed 16906017Chou WY, Wang CH, Liu PH, Liu CC, Tseng CC, Jawan B. Human opioid receptor A118G polymorphism affects intravenous patient-controlled analgesia morphine consumption after total abdominal hysterectomy. Anesthesiology. 2006 Aug;105(2):334-7. doi: 10.1097/00000542-200608000-00016.
PubMed 16871067Chou WY, Yang LC, Lu HF, Ko JY, Wang CH, Lin SH, Lee TH, Concejero A, Hsu CJ. Association of mu-opioid receptor gene polymorphism (A118G) with variations in morphine consumption for analgesia after total knee arthroplasty. Acta Anaesthesiol Scand. 2006 Aug;50(7):787-92. doi: 10.1111/j.1399-6576.2006.01058.x.
PubMed 16879459Klepstad P, Rakvag TT, Kaasa S, Holthe M, Dale O, Borchgrevink PC, Baar C, Vikan T, Krokan HE, Skorpen F. The 118 A > G polymorphism in the human mu-opioid receptor gene may increase morphine requirements in patients with pain caused by malignant disease. Acta Anaesthesiol Scand. 2004 Nov;48(10):1232-9. doi: 10.1111/j.1399-6576.2004.00517.x.
PubMed 15504181Reyes-Gibby CC, Shete S, Rakvag T, Bhat SV, Skorpen F, Bruera E, Kaasa S, Klepstad P. Exploring joint effects of genes and the clinical efficacy of morphine for cancer pain: OPRM1 and COMT gene. Pain. 2007 Jul;130(1-2):25-30. doi: 10.1016/j.pain.2006.10.023. Epub 2006 Dec 6.
PubMed 17156920Pasternak GW. The pharmacology of mu analgesics: from patients to genes. Neuroscientist. 2001 Jun;7(3):220-31. doi: 10.1177/107385840100700307.
PubMed 11499401Coulbault L, Beaussier M, Verstuyft C, Weickmans H, Dubert L, Tregouet D, Descot C, Parc Y, Lienhart A, Jaillon P, Becquemont L. Environmental and genetic factors associated with morphine response in the postoperative period. Clin Pharmacol Ther. 2006 Apr;79(4):316-24. doi: 10.1016/j.clpt.2006.01.007.
PubMed 16580900Coller JK, Barratt DT, Dahlen K, Loennechen MH, Somogyi AA. ABCB1 genetic variability and methadone dosage requirements in opioid-dependent individuals. Clin Pharmacol Ther. 2006 Dec;80(6):682-90. doi: 10.1016/j.clpt.2006.09.011.
PubMed 17178268
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalizing Perioperative Morphine Analgesia for Adolescents Undergoing Major Spine Surgeries
- ClinicalTrials.gov ID
- NCT01839461
- Acronym / sponsor ID
- 2009-0973
- Conditions
- Pain
- Keywords
- Pharmacogenetics, postoperative, pediatric, opioid, perioperative, respiratory depression, chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 24 Apr 2013 (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 research study is to identify factors and genes (the DNA material that determines the makeup of the human body) that may be associated with how children cope with pain and respond to pain medication. Morphine is a pain medication commonly prescribed after this surgery during the hospital stay. The investigators want to study factors that may be associated with morphine requirement after surgery and side-effects from morphine. They will use pharmacometric models to identify dosing guidelines and factors associated with individual variability in metabolism and efficacy/safety of morphine. They will also study psychological, genetic and epigenetic factors associated with acute and chronic post-surgical pain after spine surgery. The investigators expect that the information obtained in this research study will help to develop effective, safer, and tailored treatment options in the future.
Detailed description
Safe and effective analgesia is an important unmet medical need in children. Despite efforts to promote non-pharmacologic interventions, drug treatment remains the standard of care for children experiencing severe pain following surgery. Inadequate pain relief after invasive surgery, and side effects from analgesics such as morphine occur frequently in up to 50% of children. A study of patient-controlled analgesia morphine use after spine surgery in adolescents observed a 45% incidence of postoperative nausea and vomiting 15% incidence of pruritis and 7% incidence of respiratory depression. Among the drugs available, the opioids, specifically morphine is the most commonly employed. Morphine has a narrow therapeutic index, with the most fatal toxicity being respiratory depression. For morphine, like most opioids, there is a fine balance in dosing regimen between optimal pain control and safety in terms of decreasing morphine's respiratory depressant/ sedative side effects. Inadequate pain relief and analgesic side effects have major clinical, behavioral and economic consequences. Neither evidence-based dosing guidelines nor rigorous documentation of therapeutic benefit for morphine has been ascertained in the pediatric patient population. Despite aggressive pain management after spine surgery, findings showed that neither children's pain nor their analgesic use diminished significantly over time. As such, there is a critical knowledge gap in the medical literature that significantly impacts the pediatric pain management. In recognition of this therapeutic challenge the investigators plan to evaluate the determinants of inter-individual differences in opioid analgesic responsiveness and adverse effects in children. Adolescents following spine surgery have a great variability in morphine requirements with greater use as they became older. Analgesic dosing is dependent on appreciation of the interplay between pharmacokinetics, pharmacodynamics and therapeutics. These factors are often poorly understood, where the effective control of procedural pain for example, remains problematic. Suitable pharmacological alternatives to opioid treatment for moderate to severe pain in children after surgery are limited and consequently there is a need for a critical evaluation of the existing opioids and research reports.
Recently a number of small studies have shown the association of single nucleotide polymorphism in genes in the pain pathway, with altered pain response to a stimulus or altered response to opioids following a painful procedure. Age, gender, cultural influences, anxiety, type of surgical procedure and genetic factors can all influence the response. By extending follow up of patients to years after surgery, the aims were amended to include evaluation of chronic post-surgical outcomes.
We will be collecting data on pain scores, opioid effects, psychological questionnaires, blood samples and pupillometry data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children ages 10 to 18, inclusive, years scheduled for spinal surgical procedures.
Key inclusion criteria (3 listed)
- Children aged 10 to 18, inclusive, years of age
- Diagnosis of Idiopathic scoliosis, kyphosis and/or kyphoscoliosis
- Scheduled for spine fusion
Key exclusion criteria (8 listed)
- Known hypersensitivity to morphine
- Patients on chronic pain medication.
- Pregnant or breastfeeding females.
- Children with a history of or active renal or liver disease.
- Concomitant use of medication known to induce or inhibit CYP2D6 activity including paroxetine, fluoxetine, cimetidine, duloxetine or methadone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immediate postoperative pain scores in the recovery room
Time frame: 1 day ( Recovery room)
Pain score will be measured using standard and validated scales, Numeric rating scale (NRS 0 - 10). This scale has been widely validated and discriminates mild, moderate and severe pain
4 secondary outcomes
postoperative intravenous morphine requirement
Time frame: First 48 hours after surgery
Chronic pain pre-operatively
Time frame: Pre-operative
Chronic pain post-operatively
Time frame: 2 - 6 months post-operative
Chronic pain post-operatively
Time frame: 10 - 12 months post-operative
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 7 Oct 2019.
- Background: PubMed 8930721Beaulieu P, Cyrenne L, Mathews S, Villeneuve E, Vischoff D. Patient-controlled analgesia after spinal fusion for idiopathic scoliosis. Int Orthop. 1996;20(5):295-9. doi: 10.1007/s002640050081.
- Background: PubMed 17296267Rahim-Williams FB, Riley JL 3rd, Herrera D, Campbell CM, Hastie BA, Fillingim RB. Ethnic identity predicts experimental pain sensitivity in African Americans and Hispanics. Pain. 2007 May;129(1-2):177-84. doi: 10.1016/j.pain.2006.12.016. Epub 2007 Feb 12.
- Background: PubMed 15927391Rakvag TT, Klepstad P, Baar C, Kvam TM, Dale O, Kaasa S, Krokan HE, Skorpen F. The Val158Met polymorphism of the human catechol-O-methyltransferase (COMT) gene may influence morphine requirements in cancer pain patients. Pain. 2005 Jul;116(1-2):73-8. doi: 10.1016/j.pain.2005.03.032.
- Background: PubMed 17084978Nackley AG, Tan KS, Fecho K, Flood P, Diatchenko L, Maixner W. Catechol-O-methyltransferase inhibition increases pain sensitivity through activation of both beta2- and beta3-adrenergic receptors. Pain. 2007 Apr;128(3):199-208. doi: 10.1016/j.pain.2006.09.022. Epub 2006 Nov 7.
- Background: PubMed 16837133Diatchenko L, Nackley AG, Slade GD, Bhalang K, Belfer I, Max MB, Goldman D, Maixner W. Catechol-O-methyltransferase gene polymorphisms are associated with multiple pain-evoking stimuli. Pain. 2006 Dec 5;125(3):216-224. doi: 10.1016/j.pain.2006.05.024. Epub 2006 Jul 11.
- Background: PubMed 15537663Diatchenko L, Slade GD, Nackley AG, Bhalang K, Sigurdsson A, Belfer I, Goldman D, Xu K, Shabalina SA, Shagin D, Max MB, Makarov SS, Maixner W. Genetic basis for individual variations in pain perception and the development of a chronic pain condition. Hum Mol Genet. 2005 Jan 1;14(1):135-43. doi: 10.1093/hmg/ddi013. Epub 2004 Nov 10.
- Background: PubMed 12595695Zubieta JK, Heitzeg MM, Smith YR, Bueller JA, Xu K, Xu Y, Koeppe RA, Stohler CS, Goldman D. COMT val158met genotype affects mu-opioid neurotransmitter responses to a pain stressor. Science. 2003 Feb 21;299(5610):1240-3. doi: 10.1126/science.1078546.
- Background: PubMed 16906017Oertel BG, Schmidt R, Schneider A, Geisslinger G, Lotsch J. The mu-opioid receptor gene polymorphism 118A>G depletes alfentanil-induced analgesia and protects against respiratory depression in homozygous carriers. Pharmacogenet Genomics. 2006 Sep;16(9):625-36. doi: 10.1097/01.fpc.0000220566.90466.a2.
- Background: PubMed 16871067Chou WY, Wang CH, Liu PH, Liu CC, Tseng CC, Jawan B. Human opioid receptor A118G polymorphism affects intravenous patient-controlled analgesia morphine consumption after total abdominal hysterectomy. Anesthesiology. 2006 Aug;105(2):334-7. doi: 10.1097/00000542-200608000-00016.
- Background: PubMed 16879459Chou WY, Yang LC, Lu HF, Ko JY, Wang CH, Lin SH, Lee TH, Concejero A, Hsu CJ. Association of mu-opioid receptor gene polymorphism (A118G) with variations in morphine consumption for analgesia after total knee arthroplasty. Acta Anaesthesiol Scand. 2006 Aug;50(7):787-92. doi: 10.1111/j.1399-6576.2006.01058.x.
- Background: PubMed 15504181Klepstad P, Rakvag TT, Kaasa S, Holthe M, Dale O, Borchgrevink PC, Baar C, Vikan T, Krokan HE, Skorpen F. The 118 A > G polymorphism in the human mu-opioid receptor gene may increase morphine requirements in patients with pain caused by malignant disease. Acta Anaesthesiol Scand. 2004 Nov;48(10):1232-9. doi: 10.1111/j.1399-6576.2004.00517.x.
- Background: PubMed 17156920Reyes-Gibby CC, Shete S, Rakvag T, Bhat SV, Skorpen F, Bruera E, Kaasa S, Klepstad P. Exploring joint effects of genes and the clinical efficacy of morphine for cancer pain: OPRM1 and COMT gene. Pain. 2007 Jul;130(1-2):25-30. doi: 10.1016/j.pain.2006.10.023. Epub 2006 Dec 6.
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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.
Vidya Chidambaran, MD principal investigator
Cincinnati Childrens Hospital Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 7 Oct 2019. 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 States. 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?
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?
Immediate postoperative pain scores in the recovery room (time frame: 1 day ( Recovery room)). 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 NCT01839461, which also lists 73 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 7 Oct 2019.