A Phase 2 interventional study of Alvimopan and Placebo in Ileus, sponsored by University of California, San Diego. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-18.
Sponsored by University of California, San Diego · Phase 2, Interventional, and Treatment
The purpose of this study is to investigate the ability of alvimopan to reduce the time to return of bowel function in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Half of the participants will receive alvimopan or and half will receive placebo immediately before and for up to seven days after surgery.
Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a surgical procedure to treat cancer that has spread to the lining of the abdominal cavity (peritoneal metastases). It is associated with a prolonged time for return of bowel function after surgery.
Alvimopan is a drug used to speed up the time for return of bowel function after surgery. It works by blocking the opioid receptors in the gastrointestinal tract, which normally slow down bowel function in patients receiving postoperative opioid pain medication. It has not previously been tested in patients undergoing CRS/HIPEC.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's enrollment of 84 is close to the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
alvimopan 12 mg PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge
Drug: Alvimopan
Placebo pill PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge
Drug: Placebo
alvimopan pill
Also known as: Entereg
placebo pill
Also known as: Placebi
Time to Return of Upper and Lower GI Function
The later of the time from surgery that the participant first tolerates solid food and the time that the participant first passes a bowel movement.
Time frame: from surgery to discharge (generally no longer than two weeks)
Prolonged Ileus
The proportion of patients who do not pass flatus or bowel movement greater than 7 days from the time of surgery.
Time frame: from surgery to discharge (generally no longer than two weeks)
Time to Return of Bowel Function Components
The time from surgery until: * The time to first flatus * The time to first bowel movement * The time to tolerance of solid food
Time frame: from surgery to discharge (generally no longer than two weeks)
Time to Discharge
The time from surgery until discharge order written.
Time frame: from surgery to discharge (generally no longer than two weeks)
Serious Adverse Events
The number and proportion of serious adverse events.
Time frame: up to 30 days from surgery
Subgroup Analyses
All primary and secondary outcomes will be measured in the following subgroups: * 0 vs. 1 or greater bowel anastomoses * 0 vs. 1 or greater visceral resections * high vs. low amount of postoperative opioid use * epidural vs. no epidural
Time frame: up to 30 days from surgery
| Milestone | Alvimopan | Placebo |
|---|---|---|
| Started | 42 | 42 |
| Allocated | 30 | 32 |
| Completed | 30 | 32 |
| Not completed | 12 | 10 |
| Withdrew: Ineligible by operative criteria | 12 | 10 |
The later of the time from surgery that the participant first tolerates solid food and the time that the participant first passes a bowel movement.
| hours | Alvimopan | Placebo |
|---|---|---|
| Time to Return of Upper and Lower GI Function | 117 (102 to 158) | 152 (134 to 204) |
The proportion of patients who do not pass flatus or bowel movement greater than 7 days from the time of surgery.
| Participants | Alvimopan | Placebo |
|---|---|---|
| Prolonged Ileus | 3 | 12 |
The time from surgery until: * The time to first flatus * The time to first bowel movement * The time to tolerance of solid food
| hours | Alvimopan | Placebo |
|---|---|---|
| Time to first flatus | 64 (51 to 93) | 79 (63 to 97) |
| Time to first BM | 67 (62 to 89) | 89 (71 to 114) |
| Time to tolerance of solid food | 117 (102 to 158) | 149 (134 to 188) |
The time from surgery until discharge order written.
| hours | Alvimopan | Placebo |
|---|---|---|
| Time to Discharge | 188 (147 to 212) | 190 (187 to 236) |
The number and proportion of serious adverse events.
| Participants | Alvimopan | Placebo |
|---|---|---|
| Serious Adverse Events | 7 | 5 |
All primary and secondary outcomes will be measured in the following subgroups: * 0 vs. 1 or greater bowel anastomoses * 0 vs. 1 or greater visceral resections * high vs. low amount of postoperative opioid use * epidural vs. no epidural
No measurements were reported for this outcome.
Collected over 30 days from the the time of surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alvimopan | 0/42 (0%) | 7/42 (16.7%) | 35/42 (83.3%) |
| Placebo | 0/42 (0%) | 5/42 (11.9%) | 37/42 (88.1%) |
| Event | Alvimopan | Placebo |
|---|---|---|
| Abdominal PainGastrointestinal disorders | 4/42 | 0/42 |
| Rectal PerforationGastrointestinal disorders | 1/42 | 0/42 |
| ConstipationGastrointestinal disorders | 1/42 | 0/42 |
| Acute Kidney InjuryRenal and urinary disorders | 1/42 | 0/42 |
| Gastric PerforationGastrointestinal disorders | 0/42 | 1/42 |
| DehydrationMetabolism and nutrition disorders | 0/42 | 1/42 |
| Thromboembolic EventBlood and lymphatic system disorders | 0/42 | 1/42 |
| Cardiac ArrestCardiac disorders | 0/42 | 1/42 |
| Wound DehiscenceSurgical and medical procedures | 0/42 | 1/42 |
| Event | Alvimopan | Placebo |
|---|---|---|
| Non-Serious Adverse EventsSurgical and medical procedures | 35/42 | 37/42 |
| Age, Continuous(years) | Alvimopan | Placebo | Total |
|---|---|---|---|
| Median | 53 (27 to 73) | 61 (28 to 79) | 57 (27 to 79) |
| Sex: Female, Male(Participants) | Alvimopan | Placebo | Total |
|---|---|---|---|
| Female | 22 | 12 | 34 |
| Male | 8 | 20 | 28 |
| Race and Ethnicity Not Collected(Participants) | Alvimopan | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Study was terminated early
Ran from Mar 2018 to primary completion in Apr 2020, 25 months.
Results were first posted in Jul 2021, 1 year 2 months after primary completion.
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This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Alvimopan
University of California, San Diego →