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Opioid Antagonist
Naloxone for Opioid-Induced Constipation
Phase 3
Waitlist Available
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate to severe opioid-induced constipation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test if naloxone can relieve constipation in patients who are taking opioids for chronic pain.
Who is the study for?
This trial is for adults over 18 who are experiencing constipation due to opioid use for chronic pain, with a stable opioid dose equivalent to at least 30 mg of oral morphine. They must have fewer than three bowel movements per week and cannot be pregnant or nursing. Patients with a history of bowel obstruction, conditions causing constipation other than opioids, or significant medical issues that could interfere with the study are excluded.Check my eligibility
What is being tested?
The effectiveness of Naloxone in relieving constipation in patients taking opioids like morphine for chronic pain is being tested. This Phase III trial aims to see if Naloxone can help those who haven't had relief from other treatments and have moderate to severe opioid-induced constipation.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical reactions associated with naloxone such as gastrointestinal discomfort, nausea, vomiting, dry mouth or reversal of analgesic effects leading to increased pain perception.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I suffer from severe constipation due to my pain medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,153 Total Patients Enrolled
7 Trials studying Constipation
264 Patients Enrolled for Constipation
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,872 Total Patients Enrolled
Nathaniel Katz, MDStudy ChairDana-Farber Cancer Institute
2 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My treatment plan does not specify biologic therapy.I have finished at least one round of chemotherapy and may continue it during the study.I have fewer than 3 bowel movements per week and suffer from constipation not caused by opioids.I am younger than 18 years old.My blood cell levels have not been specified.My potassium levels are normal.I am not receiving radiotherapy to my spine, abdomen, or pelvis.I have been on a stable dose of hormonal therapy for at least 2 weeks.My treatment plan does not specify surgery.My liver condition has not been checked.I do not have any mental health conditions that would stop me from participating.I suffer from severe constipation due to my pain medication.My diabetes or hormonal conditions are under control.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Are investigators still looking for people to participate in this experiment?
"No, this specific trial is not taking on any more participants. Although the last update was on December 12th, 2018, this clinical study is no longer recruiting patients. There are, however, one hundred and thirty-six other trials that are accepting patients right now."
Answered by AI
Would this experimental treatment be appropriate for patients that are geriatric?
"Patients of any age above 18 and below 120 may be eligible for this clinical trial."
Answered by AI
Has this remedy been given the okay by the FDA?
"The safety of this treatment is estimated to be a 3. This assessment comes from the fact that this trial is a Phase 3, which suggests that not only is there some evidence backing its efficacy, but also that multiple rounds of testing have shown it to be safe."
Answered by AI
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