Postoperative Gastrointestinal DysfunctionPhase 2NCT03827655
A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery
A Phase 2 study testing TAK-954 in people with Postoperative Gastrointestinal Dysfunction, run by Takeda at 25 sites in 2 countries.
Trial summary
The main aim of this study is to check for side effects from TAK-954 and whether it speeds up the recovery of gastrointestinal function after small-bowel or large-bowel resection surgery. Participants will be treated with TAK-954 before surgery and up to 10 days after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Gastrointestinal Dysfunction
- What is being tested?
- TAK-954
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 7 Mar 2019to 27 May 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is scheduled to undergo a laparoscopic-assisted or open partial small- or large-bowel resection.
- Participant's American Society of Anesthesiologists (ASA) physical status classification is ASA 1 to 3.
Who cannot join
- Has significant mechanical bowel obstruction that is not expected to resolve after the surgery, short bowel syndrome, pre-existing clinically significant GI motility disorder (example, gastroparesis, scleroderma, chronic intestinal pseudo-obstruction), uncontrolled diabetes (glycosylated hemoglobin [HbA1c] greater than [>] 10 percent [%]), has an active gastric pacemaker, or requires parenteral nutrition.
- Had previous major abdominal surgery (example, gastrectomy, gastric bypass, gastric sleeve, lap banding, Whipple, pancreatic resection, total/subtotal colectomy, hemicolectomy, extensive bowel resection).
- Had a history of radiation therapy to the abdomen or pelvis.
- Scheduled to undergo any of the following surgeries: low anterior resection, total or subtotal colectomy, colostomy, ileostomy or reversal of stoma, or has a diagnosis that requires rectal resection (eg, tumors in the anorectum) and will likely require lower anterior resection surgery. Participants with planned surgery for which there is no anticipated significant rectal resection and is, therefore, likely to preserve anorectal function and continence postsurgery, will likely be eligible for inclusion in the study if they meet all the study inclusion/exclusion criteria (eg, participants with lesions not involving the rectum [sigmoid colon and above]).
- Has pre-existing hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points).
- Has received alvimopan, erythromycin, prucalopride, metoclopramide, domperidone, cisapride, mosapride, renzapride, or azithromycin in the 24 hours prior to starting study drug.
- Participant has known COVID-19 infection, or suspected COVID-19 infection.
- Scheduled for abdominal surgery that is classified as emergency.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States19 sites
University of Colorado
Aurora, Colorado, 80045
Fairview Hospital
Cleveland, Ohio, 44111
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
HD Research Corp.
Houston, Texas, 77024
North Star Medical
Houston, Texas, 77089
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
University of Kentucky
Lexington, Kentucky, 40536
Keck School of Medicine
Los Angeles, California, 90007
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Miami Leonard M. Miller School of Medicine
Miami, Florida, 33136
University of South Alabama Medical Center
Mobile, Alabama, 30617
Ochsner Medical Center
New Orleans, Louisiana, 70121
University of California Irvine Medical Center
Orange, California, 92868
Center for Colon & Rectal Surgery - Altamonte Springs
Orlando, Florida, 32804
Parkview Community Hospital Medical Center
Riverside, California, 92504
Stony Brook University Hospital
Stony Brook, New York, 11794
Cleveland Clinic Florida
Weston, Florida, 33331
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605
Germany6 sites
Sankt Josef-Hospital
Bochum, North Rhine-Westphalia, 44791
Universitatsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Universitatsklinikum Mannheim
Mannheim, Baden-Wurttemberg, 68167
Klinikum Rechts der Isar der Technischen Universitat Munchen
München, Bavaria, 81675
Universitaetsklinikum Regensburg
Regensburg, Bavaria, 93053
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of 2 Dose Regimens of Intravenous TAK-954 for the Prophylaxis and Treatment of Postoperative Gastrointestinal Dysfunction in Patients Undergoing Large- and Small-Bowel Resection
The main aim of this study is to check for side effects from TAK-954 and whether it speeds up the recovery of gastrointestinal function after small-bowel or large-bowel resection surgery.
Participants will be treated with TAK-954 before surgery and up to 10 days after surgery.
Read the detailed description
The drug being tested in this study is called TAK-954. In this study TAK-954 is being administered presurgery to evaluate if it can enhance the recovery of GI function postsurgery in participants undergoing open or laparoscopic-assisted partial small- or large-bowel resection. In addition, some participants will also receive TAK-954 postoperatively to evaluate if there is an additional benefit when this drug is administered both pre and post-surgery.
The study will enroll approximately 180 participants. Participants will be equally randomized into one of the three remaining parallel treatment arms- which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
All participants will be given intravenous infusion preoperation and daily postoperation until return of upper and lower GI function or for up to 10 days.
This multi-center trial will be conducted in the United States and Germany. The overall time to participate in this study is up to 100 days. Participants will be treated with the study drug for up to 10 days after surgery or until return of GI function post-surgery (whichever occurs first).
- Being tested
- TAK-954 Placebo, TAK-954
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-954 PlaceboDrug
TAK-954 placebo-matching intravenous infusion.
TAK-954Drug
TAK-954 intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days. Receives: Drug: TAK-954 Placebo |
| TAK-954 0.1 mg/100 mL | Experimental | TAK-954 0.1 milligrams per 100 milliliters (mg/100 mL), 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days. Receives: Drug: TAK-954 |
| TAK-954 0.5 mg/100 mL | Experimental | TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days. Receives: Drug: TAK-954 |
| TAK-954 0.1 mg/100 mL + Placebo | Experimental | TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function. Receives: Drug: TAK-954 Placebo; Drug: TAK-954 |
| TAK-954 0.5 mg/100 mL + Placebo | Experimental | TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function. Receives: Drug: TAK-954 Placebo; Drug: TAK-954 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator
The time from end of surgery to tolerance of solid food, without first occurrence of vomiting or clinically significant nausea for 1 calendar day after a solid meal (upper GI function) and first spontaneous bowel movement (lower GI function), whichever occurred later up to 10 days postsurgery was observed. Kaplan-Meier survival analysis method was used.
Measured: Day 1 (surgery) up to Day 10 postsurgery
Secondary outcomes (9)
Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator
The time from the end of surgery (time the incision is closed) until ready for discharge was defined as time from end of surgery until the participant presented effective intestinal transit (spontaneous bowel movement), tolerated solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal, had satisfactory pain control with oral analgesics, and was medically stable/free of complications. Kaplan-Meier survival analysis method was used.
Measured: Day 1 (surgery) up to Day 24
Time From the End of Surgery Until the Discharge Order is Written
Kaplan-Meier survival analysis method was used.
Measured: Day 1 (surgery) up to Day 24
Time From the End of Surgery to Discharge From Hospital
Kaplan-Meier survival analysis method was used.
Measured: Day 1 (surgery) up to Day 24
Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator
The time from end of surgery to tolerance of solid food was defined as intake of solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal. Kaplan-Meier survival analysis method was used.
Measured: Day 1 (surgery) up to Day 10 postsurgery
Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator
The time from end of surgery to first spontaneous bowel movement was defined as a stool not induced by the use of enemas or laxatives. Kaplan-Meier survival analysis method was used.
Measured: Day 1 (surgery) up to Day 10 postsurgery
Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) >= 5 Days as Assessed by the Investigator
Participants unable to tolerate solid foods, take anything by mouth, or requiring insertion or reinsertion of nasogastric (NG) tube at or after 5 days post-surgery. Percentages are rounded off to whole number at the nearest single decimal. Stratified Miettinen and Nurminen approach was used for analysis.
Measured: Day 1 (surgery) up to Day 10
Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery
Participants who required insertion of NG tube postsurgery for drainage and symptom relief in case of persistent nausea and vomiting postsurgery were observed. Percentages are rounded off to whole number at the nearest single decimal. Stratified Miettinen and Nurminen approach was used for analysis.
Measured: Day 1 (surgery) up to Day 24 postsurgery (10 days of treatment period postsurgery plus 14-day observation period post last dose for recurrence of symptoms)
Time From End of Surgery to First Flatus
Kaplan-Meier survival analysis method was used.
Measured: Day 1 (surgery) up to first flatus (up to Day 10 postsurgery)
Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1
Measured: Day 1 (surgery): postinfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start7 Mar 2019
- Primary completion27 May 2022
- Study completion27 May 2022
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.
- Other trials for Postoperative Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827655
- Sponsor's protocol ID
- TAK-954-2004
- Other IDs
- 2018-003318-42, U1111-1222-4784, 2018
- Status last verified
- May 2023
- First submitted
- 30 Jan 2019
- Last updated
- 23 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of 2 Dose Regimens of Intravenous TAK-954 for the Prophylaxis and Treatment of Postoperative Gastrointestinal Dysfunction in Patients Undergoing Large- and Small-Bowel Resection
- ClinicalTrials.gov ID
- NCT03827655
- Acronym / sponsor ID
- TAK-954-2004
- Keywords
- Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Posted 23 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to check for side effects from TAK-954 and whether it speeds up the recovery of gastrointestinal function after small-bowel or large-bowel resection surgery.
Participants will be treated with TAK-954 before surgery and up to 10 days after surgery.
Detailed description
The drug being tested in this study is called TAK-954. In this study TAK-954 is being administered presurgery to evaluate if it can enhance the recovery of GI function postsurgery in participants undergoing open or laparoscopic-assisted partial small- or large-bowel resection. In addition, some participants will also receive TAK-954 postoperatively to evaluate if there is an additional benefit when this drug is administered both pre and post-surgery.
The study will enroll approximately 180 participants. Participants will be equally randomized into one of the three remaining parallel treatment arms- which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
All participants will be given intravenous infusion preoperation and daily postoperation until return of upper and lower GI function or for up to 10 days.
This multi-center trial will be conducted in the United States and Germany. The overall time to participate in this study is up to 100 days. Participants will be treated with the study drug for up to 10 days after surgery or until return of GI function post-surgery (whichever occurs first).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: TAK-954 PlaceboTAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days. |
| TAK-954 0.1 mg/100 mL | Experimental | Drug: TAK-954TAK-954 0.1 milligrams per 100 milliliters (mg/100 mL), 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days. |
| TAK-954 0.5 mg/100 mL | Experimental | Drug: TAK-954TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days. |
| TAK-954 0.1 mg/100 mL + Placebo | Experimental | Drug: TAK-954 Placebo, Drug: TAK-954TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function. |
| TAK-954 0.5 mg/100 mL + Placebo | Experimental | Drug: TAK-954 Placebo, Drug: TAK-954TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant is scheduled to undergo a laparoscopic-assisted or open partial small- or large-bowel resection.
- Participant's American Society of Anesthesiologists (ASA) physical status classification is ASA 1 to 3.
Key exclusion criteria (8 listed)
- Has significant mechanical bowel obstruction that is not expected to resolve after the surgery, short bowel syndrome, pre-existing clinically significant GI motility disorder (example, gastroparesis, scleroderma, chronic intestinal pseudo-obstruction), uncontrolled diabetes (glycosylated hemoglobin [HbA1c] greater than [>] 10 percent [%]), has an active gastric pacemaker, or requires parenteral nutrition.
- Had previous major abdominal surgery (example, gastrectomy, gastric bypass, gastric sleeve, lap banding, Whipple, pancreatic resection, total/subtotal colectomy, hemicolectomy, extensive bowel resection).
- Had a history of radiation therapy to the abdomen or pelvis.
- Scheduled to undergo any of the following surgeries: low anterior resection, total or subtotal colectomy, colostomy, ileostomy or reversal of stoma, or has a diagnosis that requires rectal resection (eg, tumors in the anorectum) and will likely require lower anterior resection surgery. Participants with planned surgery for which there is no anticipated significant rectal resection and is, therefore, likely to preserve anorectal function and continence postsurgery, will likely be eligible for inclusion in the study if they meet all the study inclusion/exclusion criteria (eg, participants with lesions not involving the rectum [sigmoid colon and above]).
- Has pre-existing hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points).
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 |
|---|---|---|
| TAK-954 PlaceboTAK-954 placebo-matching intravenous infusion. | Drug | Placebo, TAK-954 0.1 mg/100 mL + Placebo, TAK-954 0.5 mg/100 mL + Placebo |
| TAK-954TAK-954 intravenous infusion. | Drug | TAK-954 0.1 mg/100 mL, TAK-954 0.1 mg/100 mL + Placebo, TAK-954 0.5 mg/100 mL, TAK-954 0.5 mg/100 mL + Placebo |
Primary outcome
Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator
Time frame: Day 1 (surgery) up to Day 10 postsurgery
The time from end of surgery to tolerance of solid food, without first occurrence of vomiting or clinically significant nausea for 1 calendar day after a solid meal (upper GI function) and first spontaneous bowel movement (lower GI function), whichever occurred later up to 10 days postsurgery was observed. Kaplan-Meier survival analysis method was used.
9 secondary outcomes
Time From the End of the Surgery (Time the Incision is Closed) Until Ready for Discharge as Assessed by the Investigator
Time frame: Day 1 (surgery) up to Day 24
Time From the End of Surgery Until the Discharge Order is Written
Time frame: Day 1 (surgery) up to Day 24
Time From the End of Surgery to Discharge From Hospital
Time frame: Day 1 (surgery) up to Day 24
Time From End of Surgery to Tolerance of Solid Food as Assessed by the Investigator
Time frame: Day 1 (surgery) up to Day 10 postsurgery
Time From End of Surgery to First Spontaneous Bowel Movement as Assessed by the Investigator
Time frame: Day 1 (surgery) up to Day 10 postsurgery
Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) >= 5 Days as Assessed by the Investigator
Time frame: Day 1 (surgery) up to Day 10
Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery
Time frame: Day 1 (surgery) up to Day 24 postsurgery (10 days of treatment period postsurgery plus 14-day observation period post last dose for recurrence of symptoms)
Time From End of Surgery to First Flatus
Time frame: Day 1 (surgery) up to first flatus (up to Day 10 postsurgery)
Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1
Time frame: Day 1 (surgery): postinfusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information on the study, click here/on this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a 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.
Medical Director study director
Takeda
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-954 in people with Postoperative Gastrointestinal Dysfunction, run by Takeda at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 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 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Germany. 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 23 Jun 2023). 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?
Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator (time frame: Day 1 (surgery) up to Day 10 postsurgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2023.