Colorectal SurgeryPhase 3NCT02742181
Alvimopan as Rescue in Post op Ileus
A Phase 3 study testing Alvimopan in people with Colorectal Surgery and Ileus, run by Sharon Stein at 1 site in United States.
Trial summary
This will be a prospective randomized control trial with a total of 142 patients. Patients who undergo laparoscopic or open colorectal resection, small bowel resection, or ileostomy reversal with small bowel resection that subsequently develop postoperative ileus will be eligible for enrollment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery, Ileus
- What is being tested?
- Alvimopan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2015to 1 Jul 2018
- Phase
- Phase 3
- 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
- Subjects who have benign or malignant colonic or rectal disease that have undergone laparoscopic or open colorectal resection, small bowel resection or ileostomy reversal with small bowel resection and subsequently developed postoperative ileus, defined as:
- Return to NPO status after initial diet attempts, or
- Placement of nasogastric tube
- Subjects who are 18 years of age and older
- Subjects of either gender
- Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent.
Who cannot join
- Subjects who received Entereg preoperatively.
- Subjects that have taken therapeutic doses of opioids for more than 7 days immediately prior to surgery.
- Subjects with severe hepatic impairment.
- Subjects with end-stage renal disease.
- Subjects who are pregnant.
- Subjects who were diagnosed with a complete small bowel obstruction preoperatively.
- Subjects with a medical condition that may interfere with the use of the study medication Entereg.
- Subjects who have a condition or general disability or infirmity that in the opinion of the investigator precludes further participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: A Prospective Randomized Control Trial of The Effectiveness of Entereg as a Rescue Treatment of Postoperative Ileus Following Colorectal Surgery
This will be a prospective randomized control trial with a total of 142 patients. Patients who undergo laparoscopic or open colorectal resection, small bowel resection, or ileostomy reversal with small bowel resection that subsequently develop postoperative ileus will be eligible for enrollment. If they meet inclusion/exclusion criteria, they will be randomized at the time of diagnosis of postoperative ileus to receive Entereg as rescue therapy or to receive conservative standard care.
Patients randomized to the Entereg group will be given 12mg of Entereg two times daily from the time of randomization until the return of bowel function or 5 days. Both groups will be treated with conservative standard care, including bowel rest, reduction in oral diet, and placement of nasogastric tube as clinically indicated.
Read more
All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
Primary outcome will be hospital length of stay. Secondary outcomes will include time to return of bowel function, 30-day morbidity/mortality, complications, reoperation and readmission.
Total number of patients: 142 Patients in each study group: 71
Read the detailed description
At the time of diagnosis of postoperative ileus and after enrollment and randomization, all patients will be returned to NPO status. Nasogastric tubes (NGT) may be placed for gastric decompression at the discretion of the surgical team if clinically indicated. In the event that an NGT is placed, medications will be given orally or via the NGT, which will be clamped for 30 minutes after administration. Patients will continue on standard ERAS pathways with the exception of reduction of diet. Antiemetics will be given as clinically indicated; however, no prokinetic or promotility agents will be given as scheduled dosages.
Patients randomized to the study group will be given 12mg of Entereg orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Patients randomized to the control group receive standard postoperative care.
The patient and surgical team will be able to know which arm of the study the patient is in based on documentation in the medical record of the administration of Entereg.
Patients in both groups will remain NPO until the return of bowel function, defined as passage of stool, decrease in nasogastric tube output. At this point, the nasogastric tube will be removed and a trial of oral diet will be attempted per surgeon's discretion.
Standard discharge criteria will be applied to all patients, including:
- Passage of stool
- Ability to tolerate solid food and to drink comfortably
- Adequate oral analgesia
- Patient's willingness to be discharged.
Data to be collected The medical/surgical information below will be collected as part of this research study and is all information already available as part of the patients medical chart.
- Patient name, medical record number
- Past Medical History
- Past Surgical history
- Preoperative Medications (including steroids, anticoagulation, opioid use)
- Pre-operative Diagnosis
- Patient Demographics (age, gender, BMI, ASA score)
- Procedure performed
- Time of surgery
- Wound classification
- Estimated blood loss
- Intraoperative transfusion
- Intraoperative IV fluids given
- Conversion from laparoscopic to open procedure
- Stoma creation
- Time/day surgery to ileus
- Time from surgery to medication given
- Time from ileus diagnosis to medication given
- Was there return of bowel function (flatus or stool, solid or liquid, stoma output) prior to ileus
- Intra-abdominal infection/anastomotic leak
- Time/day of return of bowel function post ileus (flatus and stool- solid or liquid, and stoma function)
- Time/day of ability to tolerate oral diet (liquid and solid food)
- Nasogastric tube placement and daily output
- Duration of nasogastric tube
- Use and type of anti-emetics given
- Total number of Entereg doses given
- Post operative complications including reoperation
- Length of stay in hospital, defined as time from surgery to discharge
- 30-day readmissions
Study Completion Completion of participation in the study will be 30 days after the date of surgery. Any readmission up to 30 days post-operatively to the hospital as a direct result of their surgery will be followed. The patients will follow-up with the surgeon in the office in approximately 3-6 weeks, which is considered standard of care for all patients undergoing colorectal surgery and is not considered part of the research study. Any patient for whom follow-up documentation is missing or incomplete shall be contacted via telephone. The purpose of the call will be to simply determine return to function and outcome. Only a co-investigator shall contact the subject and will identify themselves at the beginning of the call. Any subject can reserve the right not to participate in the phone call interview; they would remain in the study.
- Conditions
- Colorectal Surgery, Ileus
- Being tested
- Alvimopan, Control Group
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlvimopanDrug
Also called Entereg
Subjects diagnosed with a post operative ileus after surgery will be given alvimopan
Control GroupOther
Standard postoperative care
| Study group | Role | What they receive |
|---|---|---|
| Alvimopan group | Experimental | In addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days. Receives: Drug: Alvimopan |
| Control Group | Other | Patients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
Date of surgery until discharge
Measured: up to 30 days
Secondary outcomes (4)
Time to Return of Bowel Function
Date ileus identified to time of passing flatus, stool and tolerating diet
Measured: 30 days
Complications
All adverse events
Measured: 30 days
Number of Reoperations
Any reoperations within 30 days of surgery
Measured: 30 days
Number of Readmissions
Any readmissions within 30 days of surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study start2 Dec 2015
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Why it stopped: terminated due to lack of enrollment
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 (12)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharon Stein
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Sharon Stein, University Hospitals Cleveland Medical Center
- Investigators
- Sharon Stein, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742181
- Sponsor's protocol ID
- 10-15-28
- Status last verified
- Oct 2022
- First submitted
- 4 Apr 2016
- Last updated
- 18 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Story SK, Chamberlain RS. A comprehensive review of evidence-based strategies to prevent and treat postoperative ileus. Dig Surg. 2009;26(4):265-75. doi: 10.1159/000227765. Epub 2009 Jul 3.
PubMed 19590205Bauer AJ, Boeckxstaens GE. Mechanisms of postoperative ileus. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:54-60. doi: 10.1111/j.1743-3150.2004.00558.x.
PubMed 15357852Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.
PubMed 11091234Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. doi: 10.1053/cgh.2003.50012.
PubMed 15017498Luckey A, Livingston E, Tache Y. Mechanisms and treatment of postoperative ileus. Arch Surg. 2003 Feb;138(2):206-14. doi: 10.1001/archsurg.138.2.206.
PubMed 12578422Delaney CP, Brady K, Woconish D, Parmar SP, Champagne BJ. Towards optimizing perioperative colorectal care: outcomes for 1,000 consecutive laparoscopic colon procedures using enhanced recovery pathways. Am J Surg. 2012 Mar;203(3):353-5; discussion 355-6. doi: 10.1016/j.amjsurg.2011.09.017. Epub 2012 Jan 20.
PubMed 22264739Zhuang CL, Ye XZ, Zhang XD, Chen BC, Yu Z. Enhanced recovery after surgery programs versus traditional care for colorectal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2013 May;56(5):667-78. doi: 10.1097/DCR.0b013e3182812842.
PubMed 23575408Delaney CP, Wolff BG, Viscusi ER, Senagore AJ, Fort JG, Du W, Techner L, Wallin B. Alvimopan, for postoperative ileus following bowel resection: a pooled analysis of phase III studies. Ann Surg. 2007 Mar;245(3):355-63. doi: 10.1097/01.sla.0000232538.72458.93.
PubMed 17435541Delaney CP, Craver C, Gibbons MM, Rachfal AW, VandePol CJ, Cook SF, Poston SA, Calloway M, Techner L. Evaluation of clinical outcomes with alvimopan in clinical practice: a national matched-cohort study in patients undergoing bowel resection. Ann Surg. 2012 Apr;255(4):731-8. doi: 10.1097/SLA.0b013e31824a36cc.
PubMed 22388106Senagore AJ, Bauer JJ, Du W, Techner L. Alvimopan accelerates gastrointestinal recovery after bowel resection regardless of age, gender, race, or concomitant medication use. Surgery. 2007 Oct;142(4):478-86. doi: 10.1016/j.surg.2007.07.004.
PubMed 17950339Traut U, Brugger L, Kunz R, Pauli-Magnus C, Haug K, Bucher HC, Koller MT. Systemic prokinetic pharmacologic treatment for postoperative adynamic ileus following abdominal surgery in adults. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD004930. doi: 10.1002/14651858.CD004930.pub3.
PubMed 18254064Zingg U, Miskovic D, Pasternak I, Meyer P, Hamel CT, Metzger U. Effect of bisacodyl on postoperative bowel motility in elective colorectal surgery: a prospective, randomized trial. Int J Colorectal Dis. 2008 Dec;23(12):1175-83. doi: 10.1007/s00384-008-0536-7. Epub 2008 Jul 30.
PubMed 18665373
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Control Trial of The Effectiveness of Entereg as a Rescue Treatment of Postoperative Ileus Following Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02742181
- Acronym / sponsor ID
- 10-15-28
- Conditions
- Colorectal Surgery, Ileus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated due to lack of enrollment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sharon SteinUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Posted 18 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a prospective randomized control trial with a total of 142 patients. Patients who undergo laparoscopic or open colorectal resection, small bowel resection, or ileostomy reversal with small bowel resection that subsequently develop postoperative ileus will be eligible for enrollment. If they meet inclusion/exclusion criteria, they will be randomized at the time of diagnosis of postoperative ileus to receive Entereg as rescue therapy or to receive conservative standard care.
Patients randomized to the Entereg group will be given 12mg of Entereg two times daily from the time of randomization until the return of bowel function or 5 days. Both groups will be treated with conservative standard care, including bowel rest, reduction in oral diet, and placement of nasogastric tube as clinically indicated.
All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
Primary outcome will be hospital length of stay. Secondary outcomes will include time to return of bowel function, 30-day morbidity/mortality, complications, reoperation and readmission.
Total number of patients: 142 Patients in each study group: 71
Detailed description
At the time of diagnosis of postoperative ileus and after enrollment and randomization, all patients will be returned to NPO status. Nasogastric tubes (NGT) may be placed for gastric decompression at the discretion of the surgical team if clinically indicated. In the event that an NGT is placed, medications will be given orally or via the NGT, which will be clamped for 30 minutes after administration. Patients will continue on standard ERAS pathways with the exception of reduction of diet. Antiemetics will be given as clinically indicated; however, no prokinetic or promotility agents will be given as scheduled dosages.
Patients randomized to the study group will be given 12mg of Entereg orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Patients randomized to the control group receive standard postoperative care.
The patient and surgical team will be able to know which arm of the study the patient is in based on documentation in the medical record of the administration of Entereg.
Patients in both groups will remain NPO until the return of bowel function, defined as passage of stool, decrease in nasogastric tube output. At this point, the nasogastric tube will be removed and a trial of oral diet will be attempted per surgeon's discretion.
Standard discharge criteria will be applied to all patients, including:
- Passage of stool
- Ability to tolerate solid food and to drink comfortably
- Adequate oral analgesia
- Patient's willingness to be discharged.
Data to be collected The medical/surgical information below will be collected as part of this research study and is all information already available as part of the patients medical chart.
- Patient name, medical record number
- Past Medical History
- Past Surgical history
- Preoperative Medications (including steroids, anticoagulation, opioid use)
- Pre-operative Diagnosis
- Patient Demographics (age, gender, BMI, ASA score)
- Procedure performed
- Time of surgery
- Wound classification
- Estimated blood loss
- Intraoperative transfusion
- Intraoperative IV fluids given
- Conversion from laparoscopic to open procedure
- Stoma creation
- Time/day surgery to ileus
- Time from surgery to medication given
- Time from ileus diagnosis to medication given
- Was there return of bowel function (flatus or stool, solid or liquid, stoma output) prior to ileus
- Intra-abdominal infection/anastomotic leak
- Time/day of return of bowel function post ileus (flatus and stool- solid or liquid, and stoma function)
- Time/day of ability to tolerate oral diet (liquid and solid food)
- Nasogastric tube placement and daily output
- Duration of nasogastric tube
- Use and type of anti-emetics given
- Total number of Entereg doses given
- Post operative complications including reoperation
- Length of stay in hospital, defined as time from surgery to discharge
- 30-day readmissions
Study Completion Completion of participation in the study will be 30 days after the date of surgery. Any readmission up to 30 days post-operatively to the hospital as a direct result of their surgery will be followed. The patients will follow-up with the surgeon in the office in approximately 3-6 weeks, which is considered standard of care for all patients undergoing colorectal surgery and is not considered part of the research study. Any patient for whom follow-up documentation is missing or incomplete shall be contacted via telephone. The purpose of the call will be to simply determine return to function and outcome. Only a co-investigator shall contact the subject and will identify themselves at the beginning of the call. Any subject can reserve the right not to participate in the phone call interview; they would remain in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alvimopan group | Experimental | Drug: AlvimopanIn addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days. |
| Control Group | Other | Other: Control GroupPatients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who have benign or malignant colonic or rectal disease that have undergone laparoscopic or open colorectal resection, small bowel resection or ileostomy reversal with small bowel resection and subsequently developed postoperative ileus, defined as:
- Subjects who are 18 years of age and older
- Subjects of either gender
- Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent.
Key exclusion criteria (8 listed)
- Subjects who received Entereg preoperatively.
- Subjects that have taken therapeutic doses of opioids for more than 7 days immediately prior to surgery.
- Subjects with severe hepatic impairment.
- Subjects with end-stage renal disease.
- Subjects who are pregnant.
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 |
|---|---|---|
| AlvimopanAlso: EnteregSubjects diagnosed with a post operative ileus after surgery will be given alvimopan | Drug | Alvimopan group |
| Control GroupStandard postoperative care | Other | Control Group |
Primary outcome
Hospital Length of Stay
Time frame: up to 30 days
Date of surgery until discharge
4 secondary outcomes
Time to Return of Bowel Function
Time frame: 30 days
Complications
Time frame: 30 days
Number of Reoperations
Time frame: 30 days
Number of Readmissions
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19590205Story SK, Chamberlain RS. A comprehensive review of evidence-based strategies to prevent and treat postoperative ileus. Dig Surg. 2009;26(4):265-75. doi: 10.1159/000227765. Epub 2009 Jul 3.
- Background: PubMed 15357852Bauer AJ, Boeckxstaens GE. Mechanisms of postoperative ileus. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:54-60. doi: 10.1111/j.1743-3150.2004.00558.x.
- Background: PubMed 11091234Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.
- Background: PubMed 15017498Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. doi: 10.1053/cgh.2003.50012.
- Background: PubMed 12578422Luckey A, Livingston E, Tache Y. Mechanisms and treatment of postoperative ileus. Arch Surg. 2003 Feb;138(2):206-14. doi: 10.1001/archsurg.138.2.206.
- Background: PubMed 22264739Delaney CP, Brady K, Woconish D, Parmar SP, Champagne BJ. Towards optimizing perioperative colorectal care: outcomes for 1,000 consecutive laparoscopic colon procedures using enhanced recovery pathways. Am J Surg. 2012 Mar;203(3):353-5; discussion 355-6. doi: 10.1016/j.amjsurg.2011.09.017. Epub 2012 Jan 20.
- Background: PubMed 23575408Zhuang CL, Ye XZ, Zhang XD, Chen BC, Yu Z. Enhanced recovery after surgery programs versus traditional care for colorectal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2013 May;56(5):667-78. doi: 10.1097/DCR.0b013e3182812842.
- Background: PubMed 17435541Delaney CP, Wolff BG, Viscusi ER, Senagore AJ, Fort JG, Du W, Techner L, Wallin B. Alvimopan, for postoperative ileus following bowel resection: a pooled analysis of phase III studies. Ann Surg. 2007 Mar;245(3):355-63. doi: 10.1097/01.sla.0000232538.72458.93.
- Background: PubMed 22388106Delaney CP, Craver C, Gibbons MM, Rachfal AW, VandePol CJ, Cook SF, Poston SA, Calloway M, Techner L. Evaluation of clinical outcomes with alvimopan in clinical practice: a national matched-cohort study in patients undergoing bowel resection. Ann Surg. 2012 Apr;255(4):731-8. doi: 10.1097/SLA.0b013e31824a36cc.
- Background: PubMed 17950339Senagore AJ, Bauer JJ, Du W, Techner L. Alvimopan accelerates gastrointestinal recovery after bowel resection regardless of age, gender, race, or concomitant medication use. Surgery. 2007 Oct;142(4):478-86. doi: 10.1016/j.surg.2007.07.004.
- Background: PubMed 18254064Traut U, Brugger L, Kunz R, Pauli-Magnus C, Haug K, Bucher HC, Koller MT. Systemic prokinetic pharmacologic treatment for postoperative adynamic ileus following abdominal surgery in adults. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD004930. doi: 10.1002/14651858.CD004930.pub3.
- Background: PubMed 18665373Zingg U, Miskovic D, Pasternak I, Meyer P, Hamel CT, Metzger U. Effect of bisacodyl on postoperative bowel motility in elective colorectal surgery: a prospective, randomized trial. Int J Colorectal Dis. 2008 Dec;23(12):1175-83. doi: 10.1007/s00384-008-0536-7. Epub 2008 Jul 30.
- Individual participant dataSharing planned: No
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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.
Sharon Stein, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alvimopan in people with Colorectal Surgery and Ileus, run by Sharon Stein 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 6 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: stopped early, as of the sponsor's last update on 18 Nov 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 18 Nov 2022). 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?
Hospital Length of Stay (time frame: up to 30 days). 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 NCT02742181, which also lists 12 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 18 Nov 2022.