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Oxymetazoline for Bowel Incontinence
Study Summary
This trial is testing a new way to give oxymetazoline, a drug that is already used for other things. They will apply it to the anus instead of another way, to see if it is safe and effective. A total of 32 people will be enrolled and will use it every day for 11 days.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- You are currently taking medications for diabetes like insulin or other specific drugs.You are currently taking beta-blockers or cardiac glycosides for your heart condition.You have a history of or currently experience symptoms related to stomach or bowel problems like irritable bowel disease, inflammatory bowel disease, or chronic constipation.You have experienced bleeding from the rectum in the past 90 days.You are currently taking medications to thin your blood, like Coumarins, Heparins, or Factor Xa inhibitors.You have used illegal drugs in the past year or are currently using them according to the doctor's opinion.You have been sick with a severe illness within one week before the first dose of the study medication.Your body weight is within a healthy range, not too low or too high.You are currently taking medications that can affect the muscles in your rectum, such as nitrates, calcium channel blockers, alpha antagonists, or alpha agonists.You have experienced a change in your bowel habits within the past 14 days.You are allergic to oxymetazoline.You have certain conditions like glaucoma, Raynaud's disease, thromboangiitis obliterans, scleroderma, or Sjögren's syndrome.
- Group 1: Oxymetazoline applied intra analy
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
For what medical conditions is Oxymetazoline regularly prescribed?
"Oxymetazoline is mainly used to ease anesthetic conduction, yet it has also been found helpful in treating persistent facial erythema and other nasal issues such as rhinorrhoea or congestion."
Am I eligible to partake in this study?
"Aspiring participants must meet the age requirements of 18 to 60 and be suffering from fecal soiling in order to qualify for this trial. A total of 40 candidates will eventually take part in this clinical study."
Are geriatric patients able to participate in this research study?
"The specified age range for enrollment in this clinical trial is between 18 and 60 years old."
Could you provide a comprehensive summary of the experimental research pertaining to Oxymetazoline?
"At present, Oxymetazoline is the subject of 7 distinct clinical trials. None have progressed to Phase 3 yet. The majority are based in Raleigh, North carolina; however, studies for this therapeutic agent can be found at 12 other locations across America."
What potential harm could Oxymetazoline pose to individuals?
"The risk profile of Oxymetazoline is assessed as low, or 1 on a scale from 1 to 3. This evaluation was based off its Phase 1 clinical trial status, which means there is limited evidence for both safety and efficacy."
Does this medical investigation have any open enrollment slots for participants?
"Clinicaltrials.gov shows that this health study is no longer taking on patients, as the last update was made in July 31st 2022 and it had first been sent out August 20th 2018. However, there are 36 other trials actively recruiting new participants currently."
Is this a revolutionary medical trial?
"Since 2018, there has been a steady increase in the number of studies conducted on oxymetazoline. The pioneer study was sponsored by RDD Pharma Ltd and involved 40 patients. Successfully completing Phase 1 clinical trials granted Oxymetazoline its drug approval. Currently, 7 investigations are underway across 3 countries and 11 cities."
How many participants are being included in this investigation?
"Unfortunately, this medical trial is not currently accepting patients. It was first listed on August 20th 2018 but has since been edited lastly on July 31st 2022. For those searching for other studies, 29 clinical trials pertaining to fecal soiling are actively recruiting and 7 research initiatives regarding Oxymetazoline require participants."
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