Bladder CancerPhase 3NCT03216525
Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol
A Phase 3 study testing Alvimopan in people with Bladder Cancer, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in quicker return of bowel function (GI-2 recovery = time to upper [first toleration of solid food] and lower [first bowel movement] gastrointestinal recovery) compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Alvimopan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Jun 2024
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing radical cystectomy and urinary diversion via open or robotic approach.
- Man or woman between the ages of 18 and 85.
- American Society of Anesthesiologists (ASA) Physical Status Score of class 1-4
- Ileal conduit or ileal neobladder urinary diversion
- Able to understand the study procedures, agreed to participate in the study program, and voluntarily provided informed consent
Who cannot join
- Patients who met any of the following criteria were excluded from participating in the study:
- Scheduled for a partial cystectomy
- Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy
- More than three doses of opioids (oral or parenteral) within 7 days before the day of surgery
- Chemotherapy for bladder cancer within 1 month of scheduled surgery; prior neoadjuvant chemotherapy allowed.
- Pregnant (identified by a positive serum pregnancy test administered after the initial screening process and before the commencement of study activities) or lactating, or not postmenopausal (no menses for at least 1 year) and of childbearing potential and not using an accepted method of birth control (i.e, surgical sterilization; intrauterine contraceptive device; oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam; or abstinence) (Participants will be asked to use birth control for the entire study and for at least 2 weeks after the last dose of study drug.)
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- Participated in another investigational drug or medical device study within 30 days of surgery or planning to be enrolled in another investigational drug or medical device study or any study in which active patient participation was required outside normal hospital data collection during the course of this study
- Clinically significant laboratory abnormalities at screening that would have resulted in the cancellation of surgery
- Using illicit drugs or abusing alcohol
- History of previous surgeries, illness, or behavior (eg, depression, psychosis) that in the opinion of the investigator might have confounded the study results or might have posed additional risk in administering the study procedures
- Patients with severe dementia (as determined from medical records and history. Severe dementia will be defined as dementia that impacts daily functioning.)
- Patients with severe hepatic impairment.
- Patients with end-stage renal disease.
- Patients with heart failure. .
- Patients with complete gastrointestinal obstruction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Martin Barylak, 617-525-8274, mbarylak@bwh.harvard.edu
Mark A Preston, MD
About this study
Official title: A Randomized, Double-blind, Single-Center Trial of Alvimopan (Entereg) Versus Placebo in Patients Undergoing Radical Cystectomy and Urinary Diversion on an Enhanced Recovery After Surgery ERAS Protocol
To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in quicker return of bowel function (GI-2 recovery = time to upper [first toleration of solid food] and lower [first bowel movement] gastrointestinal recovery) compared to placebo.
Read the detailed description
A prospective, randomized, single-center double blind trial of Alvimopan versus placebo for improving patient outcomes and cost during radical cystectomy and urinary diversion will be performed. A randomized trial is necessary to control for all the known and unknown confounders associated with instituting this novel intervention into a surgical procedure. We will recruit 136 subjects (63 patients in each arm of the study per sample size calculation below, plus additional 10 subjects to account for drop outs). A control group will be administered a placebo in order to directly compare if the Alvimopan intervention is effective.
- Conditions
- Bladder Cancer
- Being tested
- Alvimopan, Placebo
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlvimopanDrug
Also called Entereg
To determine if Alvimopan during radical cystectomy with urinary diversion results in faster return of bowel function.
PlaceboDrug
To determine if placebo during radical cystectomy with urinary diversion results in faster return of bowel function.
| Study group | Role | What they receive |
|---|---|---|
| Oral Alvimopan | Active comparator | Oral Alvimopan (Entereg, Merck) 12 mg between 30 minutes and 3 hours before surgery start and twice-daily oral doses postoperatively beginning on day one (AM and PM dosing) until hospital discharge or a maximum of 7 days (15 in-hospital doses). Receives: Drug: Alvimopan |
| Matching Placebo | Placebo comparator | Matching placebo between 30 minutes and 3 hours before surgery start and twice-daily oral doses postoperatively beginning on day one (AM and PM dosing) until hospital discharge or a maximum of 7 days (15 in-hospital doses). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Return of Bowel Function
To achieve quicker time to return bowel function measured by a composite endpoint of both upper GI recovery (GI-2 recovery = [first toleration of solid food] and lower (first bowel movement) gastrointestinal recovery, taking Alvimopan during radical cystectomy, compared to placebo.
Measured: From Day of surgery (Day 0) to Day 30
Secondary outcomes (6)
Post-operative Length of Stay
Post operative LOS was determined by the difference between the date of hospital discharge and the date of surgery; that is the postoperative LOS for a participant was calculated as follows:(date of discharge)-(date of surgery).
Measured: Day of surgery (Day 0) to Day of Discharge (Up to Day 30)
Post-operative Morbidity
POM defined as need for nasogastric (NG) tube insertion, hospital stay prolonged because of post-operative ileus (POI) beyond 10 days, or readmission to hospital for POI within 7 days after discharge.
Measured: During hospitalization up to 7 days after surgery
30 Day Complications
Any Clavien Grade II-V complication.
Measured: Day of surgery (Day 0) to Day 30
Readmission to Hospital
Any readmission to hospital for > 24 hours after discharge.
Measured: Day of Discharge (Up to Day 30)
Open vs Robotic Radical Cystectomy
To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in decreased time to GI2 recovery
Measured: Day of Surgery (Day 0)
Cost Analysis
To evaluate costs of surgery and post-operative care between alvimopan and placebo in patients having a radical cystectomy and urinary diversion.
Measured: Day of surgery (Day 0) to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start1 Oct 2018
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, single-center double blind trial of Alvimopan versus placebo for improving patient outcomes and cost during radical cystectomy and urinary diversion.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Mark Preston, Brigham and Women's Hospital
- Investigators
- Mark A Preston, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216525
- Sponsor's protocol ID
- 2017P000330
- Status last verified
- Sep 2023
- First submitted
- 13 Mar 2017
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Publications
Vora AA, Harbin A, Rayson R, Christiansen K, Ghasemian R, Hwang J, Verghese M. Alvimopan provides rapid gastrointestinal recovery without nasogastric tube decompression after radical cystectomy and urinary diversion. Can J Urol. 2012 Jun;19(3):6293-8.
PubMed 22704317
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-Center Trial of Alvimopan (Entereg) Versus Placebo in Patients Undergoing Radical Cystectomy and Urinary Diversion on an Enhanced Recovery After Surgery ERAS Protocol
- ClinicalTrials.gov ID
- NCT03216525
- Acronym / sponsor ID
- 2017P000330
- Conditions
- Bladder Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 13 Jul 2017 (actual)
- 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.
To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in quicker return of bowel function (GI-2 recovery = time to upper [first toleration of solid food] and lower [first bowel movement] gastrointestinal recovery) compared to placebo.
Detailed description
A prospective, randomized, single-center double blind trial of Alvimopan versus placebo for improving patient outcomes and cost during radical cystectomy and urinary diversion will be performed. A randomized trial is necessary to control for all the known and unknown confounders associated with instituting this novel intervention into a surgical procedure. We will recruit 136 subjects (63 patients in each arm of the study per sample size calculation below, plus additional 10 subjects to account for drop outs). A control group will be administered a placebo in order to directly compare if the Alvimopan intervention is effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, single-center double blind trial of Alvimopan versus placebo for improving patient outcomes and cost during radical cystectomy and urinary diversion.
| Arm | Type | Receives |
|---|---|---|
| Oral Alvimopan | Active comparator | Drug: AlvimopanOral Alvimopan (Entereg, Merck) 12 mg between 30 minutes and 3 hours before surgery start and twice-daily oral doses postoperatively beginning on day one (AM and PM dosing) until hospital discharge or a maximum of 7 days (15 in-hospital doses). |
| Matching Placebo | Placebo comparator | Drug: PlaceboMatching placebo between 30 minutes and 3 hours before surgery start and twice-daily oral doses postoperatively beginning on day one (AM and PM dosing) until hospital discharge or a maximum of 7 days (15 in-hospital doses). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing radical cystectomy and urinary diversion via open or robotic approach.
- Man or woman between the ages of 18 and 85.
- American Society of Anesthesiologists (ASA) Physical Status Score of class 1-4
- Ileal conduit or ileal neobladder urinary diversion
- Able to understand the study procedures, agreed to participate in the study program, and voluntarily provided informed consent
Key exclusion criteria (15 listed)
- Patients who met any of the following criteria were excluded from participating in the study:
- Scheduled for a partial cystectomy
- Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy
- More than three doses of opioids (oral or parenteral) within 7 days before the day of surgery
- Chemotherapy for bladder cancer within 1 month of scheduled surgery; prior neoadjuvant chemotherapy allowed.
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: EnteregTo determine if Alvimopan during radical cystectomy with urinary diversion results in faster return of bowel function. | Drug | Oral Alvimopan |
| PlaceboTo determine if placebo during radical cystectomy with urinary diversion results in faster return of bowel function. | Drug | Matching Placebo |
Primary outcome
Time to Return of Bowel Function
Time frame: From Day of surgery (Day 0) to Day 30
To achieve quicker time to return bowel function measured by a composite endpoint of both upper GI recovery (GI-2 recovery = [first toleration of solid food] and lower (first bowel movement) gastrointestinal recovery, taking Alvimopan during radical cystectomy, compared to placebo.
6 secondary outcomes
Post-operative Length of Stay
Time frame: Day of surgery (Day 0) to Day of Discharge (Up to Day 30)
Post-operative Morbidity
Time frame: During hospitalization up to 7 days after surgery
30 Day Complications
Time frame: Day of surgery (Day 0) to Day 30
Readmission to Hospital
Time frame: Day of Discharge (Up to Day 30)
Open vs Robotic Radical Cystectomy
Time frame: Day of Surgery (Day 0)
Cost Analysis
Time frame: Day of surgery (Day 0) to Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 22704317Vora AA, Harbin A, Rayson R, Christiansen K, Ghasemian R, Hwang J, Verghese M. Alvimopan provides rapid gastrointestinal recovery without nasogastric tube decompression after radical cystectomy and urinary diversion. Can J Urol. 2012 Jun;19(3):6293-8.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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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.
Mark A Preston, MD principal investigator
Brigham and Women's Hospital
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 Bladder Cancer, run by Brigham and Women's Hospital 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 5 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 28 Sep 2023. 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. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Barylak (6175258274, mbarylak@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Return of Bowel Function (time frame: From Day of surgery (Day 0) to Day 30). 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 NCT03216525, 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 28 Sep 2023.