Osteoarthritis, KneePhase 2NCT02192190
A Study of LY2951742 in Participants With Mild to Moderate Osteoarthritis Knee Pain
A Phase 2 study testing LY2951742 and Celecoxib in people with Osteoarthritis, Knee, run by Eli Lilly and Company at 38 sites in United States.
Trial summary
The main purpose of this study is to test if LY2951742 relieves mild to moderate knee pain. The study drugs will be given as an injection under the skin and as an oral capsule. The study will last about 28 weeks for each participant. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- LY2951742 and Celecoxib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 38 sitesUnited States
- Study dates
- Jul 2014to Jun 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology (ACR) criteria and confirmed with X-rays and ACR functional class of I to III
- Have been on stable dose of prescription Nonsteroidal Anti-Inflammatory Drugs (NSAIDS), celecoxib, tramadol, or acetaminophen of at least 2000 mg per day for at least 20 days in the past month
- Willing to stop all analgesics for OA pain during the study
- Experienced pain while walking in the target knee of 50-90 mm inclusive on 0-100 Visual Analog Scale (VAS) with an increase in pain while walking of at least 10 mm following washout of current Osteoarthritis pain medications at screening
Who cannot join
- Allergic to LY2951742, celecoxib, other NSAIDS, including aspirin, and similar drugs
- Arthritis of the knee from other causes
- Uncontrolled hypertension
- Have OA pain that requires treatment with potent opioids, systemic corticosteroids, intra-articular injections, duloxetine, or venlafaxine
- Moderate to severe renal impairment
- Pregnant or lactating
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, 87106
Dream Team Clinical Research
Anaheim, California, 92801
The Center for Clinical Trials, Inc.
Biloxi, Mississippi, 39531
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216
Beacon Clinical Research, LLC
Brockton, Massachusetts, 02301
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
Medex Healthcare Research, Inc.
Chicago, Illinois, 60602
Avail Clinical Research LLC
DeLand, Florida, 32720
Horizons Clinical Research Center
Denver, Colorado, 80220
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
United Osteoporosis Center
Gainesville, Georgia, 30501
PharmQuest
Greensboro, North Carolina, 27408
PCPMG Clinical Research Unit
Greenville, South Carolina, 29601
Drug Trials of America
Hartsdale, New York, 10530
AGA Clinical Trials
Hialeah, Florida, 33012
Palm Springs Research Institute
Hialeah, Florida, 33012
Drug Studies America
Marietta, Georgia, 30060
ActivMed Practices & Research, Inc
Methuen, Massachusetts, 01844
Community Research Foundation Inc
Miami, Florida, 33155
Research Institute of South Florida, Inc.
Miami, Florida, 33173
M&M Medical Center
Miami, Florida, 33185
Accurate Clinical Research
Nassau Bay, Texas, 77058
Medex Healthcare Research, Inc.
New York, New York, 10016
Health Research of Hampton Roads Inc
Newport News, Virginia, 23606
National Clinical Research - Norfolk Inc
Norfolk, Virginia, 23502
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507
Renstar Medical Research
Ocala, Florida, 34471
Compass Research
Orlando, Florida, 32806
Quality Research, Inc.
San Antonio, Texas, 78209
Artemis Institute for Clinical Research
San Diego, California, 92103
Empire Clinical Research
Upland, California, 91786
Buynak Clinical Research, P.C.
Valparaiso, Indiana, 46383
Arthritis, Rheumatic & Back Disease Associates
Voorhees Township, New Jersey, 08043
Diablo Clinical Research
Walnut Creek, California, 94598
Greater Providence Clinical Research, LLC
Warwick, Rhode Island, 02888
iM Research
West Covina, California, 91760
Upstate Clinical Research Associates
Williamsville, New York, 14221
Family Practice Center of Wooster
Wooster, Ohio, 44691
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo and Active-Controlled Trial of LY2951742 in Patients With Mild to Moderate Osteoarthritis Pain of the Knee
The main purpose of this study is to test if LY2951742 relieves mild to moderate knee pain. The study drugs will be given as an injection under the skin and as an oral capsule. The study will last about 28 weeks for each participant.
- Conditions
- Osteoarthritis, Knee
- Being tested
- LY2951742, Placebo- oral, Placebo - SC, Celecoxib
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2951742Drug
Administered subcutaneously (SC)
Placebo- oralOther
Administered orally
Placebo - SCOther
Administered SC
CelecoxibDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsule orally, once daily for approximately 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks (Treatment period = 16 weeks). Receives: Other: Placebo- oral; Other: Placebo - SC |
| Celecoxib + Placebo | Active comparator | Celecoxib 200 milligram (mg) capsule orally once daily for approximately 16 weeks. Placebo SC once every 4 weeks for 16 weeks (Treatment period = 16 weeks). Receives: Other: Placebo - SC; Drug: Celecoxib |
| LY2951742 5 mg + Placebo | Experimental | Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 5 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). Receives: Drug: LY2951742; Other: Placebo- oral; Other: Placebo - SC |
| LY2951742 50 mg + Placebo | Experimental | Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 50 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). Receives: Drug: LY2951742; Other: Placebo- oral; Other: Placebo - SC |
| LY2951742 120 mg + Placebo | Experimental | Placebo capsule orally, once daily for approximately 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). Receives: Drug: LY2951742; Other: Placebo- oral; Other: Placebo - SC |
| LY2951742 300 mg + Placebo | Experimental | Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). Receives: Drug: LY2951742; Other: Placebo- oral; Other: Placebo - SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 8 Weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis (OA) symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC pain subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 millimeter [mm] VAS; 0=very good and 100=very poor) of all 5 questions related to pain. Bayesian posterior adjusted mean was calculated using a Bayesian Normal Dynamic Linear Model (NDLM) dose response model with baseline and pooled investigator site included as baseline covariates.
Measured: Baseline, 8 Weeks
Secondary outcomes (5)
Change From Baseline to 8 Weeks in the WOMAC Physical Function Subscale
The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC physical function subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of all 17 questions related to physical function. Least Square Mean (LSM) was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
Measured: Baseline, 8 Weeks
Change in Baseline to 8 Weeks in Patient's Global Assessment of Osteoarthritis
The PGA is a patient-rated instrument that measures their assessment of overall OA symptoms. It is based on the participant's response to the question "Considering all the ways your osteoarthritis affects you, how are you doing today?" using a 100 mm VAS (0=very good and 100=very poor). LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
Measured: Baseline, 8 Weeks
Number of Participants With a Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI)
The responders according to OMERACT-OARSI criteria: participants with at least 50 % improvement in pain or in function scores, along with absolute improvement of 20 mm, were considered responders. Alternatively, participants were considered responders if they showed at least 20% improvement and absolute improvement of 10 mm in at least two of the following scores: pain, function and Patients Global Assessment (PGA) scores.
Measured: 8 Weeks
Change From Baseline to 8 Weeks in the WOMAC Stiffness Subscale
The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC stiffness subscale will be calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 2 questions related to stiffness. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
Measured: Baseline, 8 Weeks
Change From Baseline to 8 Weeks in the WOMAC Total Score
The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales.The WOMAC total score was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 24 questions. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
Measured: Baseline, 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2015
- Study completionJun 2015
Why it stopped: Interim assessment: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192190
- Sponsor's protocol ID
- 15515
- Other IDs
- I5Q-MC-CGAF
- Status last verified
- Aug 2019
- First submitted
- 14 Jul 2014
- Last updated
- 10 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Jin Y, Smith C, Monteith D, Brown R, Camporeale A, McNearney TA, Deeg MA, Raddad E, Xiao N, de la Pena A, Kivitz AJ, Schnitzer TJ. CGRP blockade by galcanezumab was not associated with reductions in signs and symptoms of knee osteoarthritis in a randomized clinical trial. Osteoarthritis Cartilage. 2018 Dec;26(12):1609-1618. doi: 10.1016/j.joca.2018.08.019. Epub 2018 Sep 18.
PubMed 30240937
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo and Active-Controlled Trial of LY2951742 in Patients With Mild to Moderate Osteoarthritis Pain of the Knee
- ClinicalTrials.gov ID
- NCT02192190
- Acronym / sponsor ID
- 15515
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim assessment: Lack of efficacy
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Posted 8 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to test if LY2951742 relieves mild to moderate knee pain. The study drugs will be given as an injection under the skin and as an oral capsule. The study will last about 28 weeks for each participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo- oral, Other: Placebo - SCPlacebo capsule orally, once daily for approximately 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks (Treatment period = 16 weeks). |
| Celecoxib + Placebo | Active comparator | Other: Placebo - SC, Drug: CelecoxibCelecoxib 200 milligram (mg) capsule orally once daily for approximately 16 weeks. Placebo SC once every 4 weeks for 16 weeks (Treatment period = 16 weeks). |
| LY2951742 5 mg + Placebo | Experimental | Drug: LY2951742, Other: Placebo- oral, Other: Placebo - SCPlacebo capsule orally, once daily for approximately 16 weeks. SC injections of 5 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). |
| LY2951742 50 mg + Placebo | Experimental | Drug: LY2951742, Other: Placebo- oral, Other: Placebo - SCPlacebo capsule orally, once daily for approximately 16 weeks. SC injections of 50 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). |
| LY2951742 120 mg + Placebo | Experimental | Drug: LY2951742, Other: Placebo- oral, Other: Placebo - SCPlacebo capsule orally, once daily for approximately 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). |
| LY2951742 300 mg + Placebo | Experimental | Drug: LY2951742, Other: Placebo- oral, Other: Placebo - SCPlacebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 8 weeks followed by placebo SC once every 4 weeks for 8 weeks (Treatment period = 16 weeks). |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology (ACR) criteria and confirmed with X-rays and ACR functional class of I to III
- Have been on stable dose of prescription Nonsteroidal Anti-Inflammatory Drugs (NSAIDS), celecoxib, tramadol, or acetaminophen of at least 2000 mg per day for at least 20 days in the past month
- Willing to stop all analgesics for OA pain during the study
- Experienced pain while walking in the target knee of 50-90 mm inclusive on 0-100 Visual Analog Scale (VAS) with an increase in pain while walking of at least 10 mm following washout of current Osteoarthritis pain medications at screening
Key exclusion criteria (6 listed)
- Allergic to LY2951742, celecoxib, other NSAIDS, including aspirin, and similar drugs
- Arthritis of the knee from other causes
- Uncontrolled hypertension
- Have OA pain that requires treatment with potent opioids, systemic corticosteroids, intra-articular injections, duloxetine, or venlafaxine
- Moderate to severe renal impairment
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 |
|---|---|---|
| LY2951742Administered subcutaneously (SC) | Drug | LY2951742 120 mg + Placebo, LY2951742 300 mg + Placebo, LY2951742 5 mg + Placebo, LY2951742 50 mg + Placebo |
| Placebo- oralAdministered orally | Other | LY2951742 120 mg + Placebo, LY2951742 300 mg + Placebo, LY2951742 5 mg + Placebo, LY2951742 50 mg + Placebo, Placebo |
| Placebo - SCAdministered SC | Other | Celecoxib + Placebo, LY2951742 120 mg + Placebo, LY2951742 300 mg + Placebo, LY2951742 5 mg + Placebo, LY2951742 50 mg + Placebo, Placebo |
| CelecoxibAdministered orally | Drug | Celecoxib + Placebo |
Primary outcome
Change From Baseline to 8 Weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
Time frame: Baseline, 8 Weeks
The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis (OA) symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC pain subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 millimeter [mm] VAS; 0=very good and 100=very poor) of all 5 questions related to pain. Bayesian posterior adjusted mean was calculated using a Bayesian Normal Dynamic Linear Model (NDLM) dose response model with baseline and pooled investigator site included as baseline covariates.
5 secondary outcomes
Change From Baseline to 8 Weeks in the WOMAC Physical Function Subscale
Time frame: Baseline, 8 Weeks
Change in Baseline to 8 Weeks in Patient's Global Assessment of Osteoarthritis
Time frame: Baseline, 8 Weeks
Number of Participants With a Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI)
Time frame: 8 Weeks
Change From Baseline to 8 Weeks in the WOMAC Stiffness Subscale
Time frame: Baseline, 8 Weeks
Change From Baseline to 8 Weeks in the WOMAC Total Score
Time frame: Baseline, 8 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30240937Jin Y, Smith C, Monteith D, Brown R, Camporeale A, McNearney TA, Deeg MA, Raddad E, Xiao N, de la Pena A, Kivitz AJ, Schnitzer TJ. CGRP blockade by galcanezumab was not associated with reductions in signs and symptoms of knee osteoarthritis in a randomized clinical trial. Osteoarthritis Cartilage. 2018 Dec;26(12):1609-1618. doi: 10.1016/j.joca.2018.08.019. Epub 2018 Sep 18.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY2951742 and Celecoxib in people with Osteoarthritis, Knee, run by Eli Lilly and Company at 38 sites 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline to 8 Weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (time frame: Baseline, 8 Weeks). 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 NCT02192190, which also lists 1 linked publication.
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 10 Sep 2019.