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Alvimopan for Intestinal Obstruction
Phase 4
Recruiting
Led By Conor Delaney, MD, PhD
Research Sponsored by Scott Steele
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights
Study Summary
This trial will compare the cost effectiveness of Alvimopan to standard care, as well as safety and effectiveness in reducing length of stay and duration of postoperative ileus.
Who is the study for?
This trial is for adults who've had certain bowel surgeries and are now facing a condition where their intestines aren't working properly (postoperative ileus), causing bloating, nausea, or vomiting. They must not have used Alvimopan before surgery, can't be pregnant, shouldn't have severe liver problems or end-stage kidney disease, and haven’t been on opioids for more than a week before surgery.Check my eligibility
What is being tested?
The study tests if Alvimopan can help restart the bowels after surgery better than standard care alone. It's given to half of the patients when they show signs of intestinal blockage without actual obstruction. These patients will get up to three doses to see if it helps them recover faster.See study design
What are the potential side effects?
While not specified here, common side effects of Alvimopan may include digestive issues like constipation or diarrhea, gas, headache, back pain or difficulty sleeping. Serious side effects could involve heart problems in those with cardiovascular conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hospital Length of Stay
Secondary outcome measures
Number of re-operations
Time to return of bowel function
number of re-admissions
Side effects data
From 2012 Phase 4 trial • 280 Patients • NCT0070820119%
Hypokalaemia
19%
Anaemia
15%
Hypocalcaemia
15%
Constipation
13%
Pyrexia
13%
Insomnia
13%
Hypomagnesaemia
10%
Nausea
10%
Hyperglycaemia
9%
Diarrhoea
9%
Tachycardia
9%
Hypertension
9%
Hypotension
8%
Urinary Tract Infection
8%
Anxiety
8%
Hypophosphataemia
7%
Pruritus
6%
Oedema Peripheral
6%
Anaemia Postoperative
5%
Flatulence
5%
Postoperative Ileus
4%
Dyspepsia
4%
Abdominal Pain
4%
Hyponatraemia
4%
Renal Failure Acute
4%
Urine Output Decreased
3%
Vomiting
3%
Pyelonephritis
3%
Haemoglobin Decreased
3%
Blood Creatinine Increased
3%
Hiccups
3%
Troponin Increased
3%
Hyperkalaemia
2%
Pelvic Abscess
2%
Dehydration
2%
Malnutrition
2%
Sinus Tachycardia
1%
Bacteraemia
1%
Clostridium Difficile Colitis
1%
Clostridial Infection
1%
Cerebral Infarction
1%
Angina Pectoris
1%
Postoperative Wound Complication
1%
Procedural Hypotension
1%
Leukocytosis
1%
Ventricular Tachycardia
1%
Ascites
1%
Enterocutaneous Fistula
1%
Enterovesical Fistula
1%
Intestinal Perforation
1%
Device Malfunction
1%
Sepsis
1%
Urinary Tract Infection Staphylococcal
1%
Urosepsis
1%
Urinary Retention Postoperative
1%
Wound Dehiscence
1%
Staphylococcus Test Positive
1%
Throat Cancer
1%
Respiratory Failure
1%
Deep Vein Thrombosis
1%
Septic Shock
1%
Sudden Death
1%
Abdominal Infection
1%
Fungal Oesophagitis
1%
Fungal Sepsis
1%
Incision Site Infection
1%
Abdominal Wound Dehiscence
1%
Gastrointestinal Anastomotic Leak
1%
Gun Shot Wound
1%
Hypercalcaemia
1%
Hypovolaemia
1%
Delirium
1%
Mental Status Changes
1%
Pelvic Fluid Collection
1%
Acute Respiratory Failure
1%
Pulmonary Embolism
1%
Myocardial Infarction
1%
Back Pain
1%
Small Intestinal Obstruction
1%
Asthenia
1%
Retroperitoneal Abscess
1%
Pyelonephritis Acute
1%
Incisional Hernia
1%
Completed Suicide
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Alvimopan 12 mg
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Alvimopan GroupExperimental Treatment1 Intervention
Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function.
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.
Group II: Control GroupActive Control1 Intervention
Control patients will follow a standard ERAS pathway after surgery, including NPO status, IV fluid rehydration, and nasogastric decompression, early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alvimopan
FDA approved
Find a Location
Who is running the clinical trial?
Scott SteeleLead Sponsor
1 Previous Clinical Trials
702 Total Patients Enrolled
Conor Delaney, MD, PhD5.07 ReviewsPrincipal Investigator - The Cleveland Clinic
The Cleveland Clinic
2 Previous Clinical Trials
200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe kidney disease called end-stage renal disease.Both males and females can participate.You have taken strong painkillers called opioids for more than a week before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Alvimopan Group
Awards:
This trial has 4 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide an assessment of Alvimopan's safety profile?
"The safety profile of Alvimopan has been verified through Phase 4 trials, and our team at Power awarded this treatment a score of 3."
Answered by AI
Are there precedents of Alvimopan being utilized in any past clinical assessments?
"Presently, there are 1 active clinical trials examining the impacts of Alvimopan with 0 Phase 3 tests taking place. While Cleveland, Ohio is hosting most of these studies, there is one other site conducting related research."
Answered by AI
What is the aggregate quantity of individuals participating in this investigation?
"Affirmative. Records on clinicaltrials.gov verify that this trial is actively enlisting participants, with the initial posting being made on August 1st 2020 and the most recent update occurring on August 26th 2022. 58 individuals are needed to enroll at a single site."
Answered by AI
Is the enrollment process currently open for this trial?
"Affirmative. Information found on clinicaltrials.gov verifies that enrollment for this medical investigation, which was first advertised on August 1st 2020, is still open and active. 58 volunteers are needed from a single research site."
Answered by AI
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