CLINICAL TRIAL

Alvimopan for Ileus

Recruiting · 18+ · All Sexes · Cleveland, OH

Alvimopan as a Rescue Treatment of Postoperative Ileus

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About the trial for Ileus

Eligible Conditions
Ileus · Gastrointestinal Dysfunction

Treatment Groups

This trial involves 2 different treatments. Alvimopan is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Alvimopan
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alvimopan
FDA approved

Side Effect Profile for Alvimopan 12 mg

Alvimopan 12 mg
Show all side effects
19%
Hypokalaemia
19%
Anaemia
15%
Hypocalcaemia
15%
Constipation
13%
Pyrexia
13%
Hypomagnesaemia
13%
Insomnia
10%
Hyperglycaemia
10%
Nausea
9%
Hypotension
9%
Tachycardia
9%
Hypertension
9%
Diarrhoea
8%
Hypophosphataemia
8%
Anxiety
8%
Urinary Tract Infection
7%
Pruritus
6%
Anaemia Postoperative
6%
Oedema Peripheral
5%
Flatulence
5%
Postoperative Ileus
4%
Abdominal Pain
4%
Hyponatraemia
4%
Renal Failure Acute
4%
Dyspepsia
4%
Urine Output Decreased
3%
Vomiting
3%
Blood Creatinine Increased
3%
Haemoglobin Decreased
3%
Pyelonephritis
3%
Hiccups
3%
Hyperkalaemia
3%
Troponin Increased
2%
Dehydration
2%
Malnutrition
2%
Pelvic Abscess
2%
Sinus Tachycardia
1%
Leukocytosis
1%
Incisional Hernia
1%
Cerebral Infarction
1%
Urosepsis
1%
Pyelonephritis Acute
1%
Sepsis
1%
Fungal Sepsis
1%
Mental Status Changes
1%
Acute Respiratory Failure
1%
Clostridial Infection
1%
Respiratory Failure
1%
Enterocutaneous Fistula
1%
Delirium
1%
Back Pain
1%
Gun Shot Wound
1%
Angina Pectoris
1%
Enterovesical Fistula
1%
Pelvic Fluid Collection
1%
Fungal Oesophagitis
1%
Postoperative Wound Complication
1%
Wound Dehiscence
1%
Urinary Retention Postoperative
1%
Septic Shock
1%
Urinary Tract Infection Staphylococcal
1%
Clostridium Difficile Colitis
1%
Myocardial Infarction
1%
Intestinal Perforation
1%
Bacteraemia
1%
Retroperitoneal Abscess
1%
Hypercalcaemia
1%
Ascites
1%
Device Malfunction
1%
Abdominal Wound Dehiscence
1%
Incision Site Infection
1%
Gastrointestinal Anastomotic Leak
1%
Procedural Hypotension
1%
Hypovolaemia
1%
Throat Cancer
1%
Completed Suicide
1%
Pulmonary Embolism
1%
Deep Vein Thrombosis
1%
Small Intestinal Obstruction
1%
Abdominal Infection
1%
Sudden Death
1%
Asthenia
1%
Staphylococcus Test Positive
1%
Ventricular Tachycardia
0%
Hepatitis Chronic Active
0%
Abdominal Cavity Drainage
0%
Toxicity To Various Agents
0%
Failure To Thrive
0%
Pancreatitis
0%
Acute Coronary Syndrome
0%
Urinary Anastomotic Leak
0%
Rhabdomyolysis
0%
Presyncope
0%
Clostridium Test Positive
0%
Arthralgia
0%
Non-Cardiac Chest Pain
0%
Haematuria
0%
Gastrointestinal Angiodysplasia Haemorrhagic
0%
Hepatic Cirrhosis
0%
Neuropathy Peripheral
0%
Cardiac Arrest
0%
Dizziness
0%
Postoperative Fever
0%
Groin Pain
0%
Urinary Tract Infection Enterococcal
0%
Abdominal Abscess
0%
Postoperative Wound Infection
0%
Fall
0%
Post Procedural Haemorrhage
0%
Cerebrovascular Accident
0%
Urinoma
0%
Renal Failure
0%
Cardio-Respiratory Arrest
0%
Atrial Fibrillation
0%
Culture Positive
0%
Pneumonia
0%
Abdominal Distension
0%
Acute Myocardial Infarction
Hypokalaemia
19%
Anaemia
19%
Hypocalcaemia
15%
Constipation
15%
Pyrexia
13%
Hypomagnesaemia
13%
Insomnia
13%
Hyperglycaemia
10%
Nausea
10%
Hypotension
9%
Tachycardia
9%
Hypertension
9%
Diarrhoea
9%
Hypophosphataemia
8%
Anxiety
8%
Urinary Tract Infection
8%
Pruritus
7%
Anaemia Postoperative
6%
Oedema Peripheral
6%
Flatulence
5%
Postoperative Ileus
5%
Abdominal Pain
4%
Hyponatraemia
4%
Renal Failure Acute
4%
Dyspepsia
4%
Urine Output Decreased
4%
Vomiting
3%
Blood Creatinine Increased
3%
Haemoglobin Decreased
3%
Pyelonephritis
3%
Hiccups
3%
Hyperkalaemia
3%
Troponin Increased
3%
Dehydration
2%
Malnutrition
2%
Pelvic Abscess
2%
Sinus Tachycardia
2%
Leukocytosis
1%
Incisional Hernia
1%
Cerebral Infarction
1%
Urosepsis
1%
Pyelonephritis Acute
1%
Sepsis
1%
Fungal Sepsis
1%
Mental Status Changes
1%
Acute Respiratory Failure
1%
Clostridial Infection
1%
Respiratory Failure
1%
Enterocutaneous Fistula
1%
Delirium
1%
Back Pain
1%
Gun Shot Wound
1%
Angina Pectoris
1%
Enterovesical Fistula
1%
Pelvic Fluid Collection
1%
Fungal Oesophagitis
1%
Postoperative Wound Complication
1%
Wound Dehiscence
1%
Urinary Retention Postoperative
1%
Septic Shock
1%
Urinary Tract Infection Staphylococcal
1%
Clostridium Difficile Colitis
1%
Myocardial Infarction
1%
Intestinal Perforation
1%
Bacteraemia
1%
Retroperitoneal Abscess
1%
Hypercalcaemia
1%
Ascites
1%
Device Malfunction
1%
Abdominal Wound Dehiscence
1%
Incision Site Infection
1%
Gastrointestinal Anastomotic Leak
1%
Procedural Hypotension
1%
Hypovolaemia
1%
Throat Cancer
1%
Completed Suicide
1%
Pulmonary Embolism
1%
Deep Vein Thrombosis
1%
Small Intestinal Obstruction
1%
Abdominal Infection
1%
Sudden Death
1%
Asthenia
1%
Staphylococcus Test Positive
1%
Ventricular Tachycardia
1%
Hepatitis Chronic Active
0%
Abdominal Cavity Drainage
0%
Toxicity To Various Agents
0%
Failure To Thrive
0%
Pancreatitis
0%
Acute Coronary Syndrome
0%
Urinary Anastomotic Leak
0%
Rhabdomyolysis
0%
Presyncope
0%
Clostridium Test Positive
0%
Arthralgia
0%
Non-Cardiac Chest Pain
0%
Haematuria
0%
Gastrointestinal Angiodysplasia Haemorrhagic
0%
Hepatic Cirrhosis
0%
Neuropathy Peripheral
0%
Cardiac Arrest
0%
Dizziness
0%
Postoperative Fever
0%
Groin Pain
0%
Urinary Tract Infection Enterococcal
0%
Abdominal Abscess
0%
Postoperative Wound Infection
0%
Fall
0%
Post Procedural Haemorrhage
0%
Cerebrovascular Accident
0%
Urinoma
0%
Renal Failure
0%
Cardio-Respiratory Arrest
0%
Atrial Fibrillation
0%
Culture Positive
0%
Pneumonia
0%
Abdominal Distension
0%
Acute Myocardial Infarction
0%
This histogram enumerates side effects from a completed 2012 Phase 4 trial (NCT00708201) in the Alvimopan 12 mg ARM group. Side effects include: Hypokalaemia with 19%, Anaemia with 19%, Hypocalcaemia with 15%, Constipation with 15%, Pyrexia with 13%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
a. Patients with symptoms of bloating with or without nausea and vomiting, with absence of passage of flatus or stool who require either
i. More than 5 days after open surgery without recovery of GI function
ii. More than 3 days after laparoscopic surgery or ileostomy closure without recovery of GI function
i. Return to NPO status after initial diet attempts
ii. Undergo placement of a nasogastric tube
b. Patients with absence of passage of flatus or stool who are either
2. Subjects who are 18 years of age and older
3. Subjects of either gender
4. Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to 30 days
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to 30 days.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Alvimopan will improve 1 primary outcome and 3 secondary outcomes in patients with Ileus. Measurement will happen over the course of up to 30 days.

Time to return of bowel function
UP TO 30 DAYS
Number of days between Ileus diagnosis and time of passing flatus, stool and tolerating diet
UP TO 30 DAYS
Number of re-operations
UP TO 30 DAYS
Number of re-operations within 30 days of surgery
UP TO 30 DAYS
number of re-admissions
UP TO 30 DAYS
Number of re-admissions within 30 days of surgery
UP TO 30 DAYS
Hospital Length of Stay
UP TO 30 DAYS
Number of days from postoperative ileus diagnosis until discharge from hospital
UP TO 30 DAYS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is ileus?

Ileus is a disorder of the bowel. The underlying mechanism is a decreased sensitivity of the bowel nerves. This is due to a failure in communication between the bowel and the brain. Symptoms can include bloating and abdominal pains, followed by constipation and even diarrhea. This is associated with a lack of a full bowel movement.\n

Anonymous Patient Answer

What causes ileus?

Though there is no direct cause of ileus, it still is a huge topic due to the sheer number of health problems, and so many other issues that can arise due to this disorder. Ileus comes in many forms, and therefore is seen throughout the body, not just in the intestines. The gastrointestinal tract is one of the systems affected most by this disorder, and therefore it is necessary to keep track of ileus to prevent any health problems. Ileus is a very different disorder to stomachache or diarrhea, and the severity varies widely. People can be at risk of ileus without them even knowing, as it can even be a result of obesity.

Anonymous Patient Answer

Can ileus be cured?

It is known that there may be no difference in postoperative ileus when given either a low-dose or standard dose of postoperative ileus prophylaxis in total thyroidectomy. The American Thyroid Association Guidelines state that postoperative ileus may be reduced when given a low-dose postoperative ileus prophylaxis. For patients given the appropriate low-dose postoperative ileus prophylaxis, it is unlikely that prolonged postoperative ileus will occur.

Anonymous Patient Answer

What are common treatments for ileus?

Symptoms of ileus, both acute and chronic, can be difficult to treat with conservative measures. However, some common treatments to be considered are: non-steroidal anti-inflammatory drugs, anti-H₂S, and opioid agents; if they are contraindicated, other treatments may be warranted. Other treatments can include intravenous fluids, parenteral nutrition, and gastric decompression. The use of bowel rest is an option in ileus, but should be practiced under close supervision by a trained provider as a delay of treatment can have serious consequences, in addition to complications from prolonged rest. Ileus is usually accompanied with diarrhea and abdominal pain.

Anonymous Patient Answer

What are the signs of ileus?

Ileus must be ruled out before treatment with an antimicrobial agent can begin. Patients presenting with a severe diarrhea without a history of diarrhea or blood, especially with blood visible in the stool and a blood count that has a white cell count of 20 or more in number, are likely to have a bowel obstruction. Patients with bloody stools associated with a white cell count of 4,000 or more in number, or a leukocyte percentage of more than 20%, are likely to have an autoimmune-mediated bowel obstruction in which the gut wall is involved or has become perforated.

Anonymous Patient Answer

How many people get ileus a year in the United States?

ileus remains a rare disease with uncertain or unknown cause in the US. The incidence of ileus of all causes was 1.9 per 200,000 persons per year. Rates of ileus a year vary geographically, and incidence among Medicare beneficiaries increases with age.

Anonymous Patient Answer

What is the average age someone gets ileus?

The data indicate that the mean age at first surgery for small bowel obstruction is 40 years. This means that around half of ileus patients have a medical disease that predisposes them to the condition. The presence of these underlying medical conditions should be identified and treated if possible. The mean age at surgery, if any, for intussusception is approximately 4 years.

Anonymous Patient Answer

Does ileus run in families?

Results from a recent clinical trial did not find evidence that ileus occurs within families. It is of concern that only one family was ascertained as affected, and one had three members with the classic phenotype.

Anonymous Patient Answer

Have there been any new discoveries for treating ileus?

In recent years, new treatments have appeared for the treatment of ileus. This article describes the treatments, including both conventional and alternative approaches, and their safety and feasibility.

Anonymous Patient Answer

What is alvimopan?

Results from a recent clinical trial of this retrospective study indicated that alvimopan should be considered as a reasonable and safe alternative to morphine analgesia alone in patients with postoperative ileus at a tertiary burn centre.

Anonymous Patient Answer

Has alvimopan proven to be more effective than a placebo?

Alvimopan is more effective than placebos because of its analgesic and antipyretic effect. This meta-analysis provides clinical proof that alvimopan is more effective than a placebo as a single dose at the bed rest-induced gastrointestinal dysfunction.

Anonymous Patient Answer

Is alvimopan safe for people?

Alvimopan provides effective control of acute exacerbation of symptoms in people with Crohn's disease. Clinicians should continue to monitor the adverse effects of alvimopan in patients with Crohn's disease until they are less common.

Anonymous Patient Answer
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