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Low-dose naltrexone for Interstitial Cystitis
Study Summary
This trial will test if low-dose naltrexone improves pain and urinary symptoms in patients with interstitial cystitis/bladder pain syndrome.
- Interstitial Cystitis
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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Who is running the clinical trial?
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- You cannot have had botox injections in the past 6 months.You have started taking a new over-the-counter medication or made a change to your over-the-counter medication within the past 2 months.You have been experiencing pain, pressure, or discomfort in your bladder area for more than 6 weeks and no infection or other identifiable cause has been found.You have severe pain in your bladder or pelvic area, need to urinate frequently during the day, wake up to urinate at least twice a night, and your BPIC-SS score is 19 or higher.You have long-term pain in another part of your body that is worse than the pain caused by bladder pain syndrome.You have been diagnosed with a drug addiction, including addiction to opioids.You are currently enrolled in another clinical trial.You have had medication placed directly into your bladder within the past 8 weeks.Both men and women with a certain type of bladder condition called non-Hunner and Hunner lesion disease.You are allergic to naltrexone or naloxone.You cannot take opioids during the study.You have used opioids regularly to manage IC/BPS pain in the past, and have not been off them for at least a year.You have received treatment for Hunners in the past 6 months.You have not received pelvic floor physical therapy in the last 12 weeks.
- Group 1: Placebo
- Group 2: Low-dose naltrexone
- 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
How many patients does this trial have space for?
"That is correct. The clinical trial was posted on October 8th, 2020 and is currently enrolling 40 patients at 1 location, according to the data available on clinicaltrials.gov"
Are we currently looking for participants in this research?
"That is correct. The information available on clinicaltrials.gov verifies that this trial, which was originally advertised on October 8th 2020, currently has open enrolment slots. Up to 40 patients can be accepted from a single site."
Can you explain the benefits of Low-dose naltrexone?
"Low-dose naltrexone has been successful in treating chronic weight management, increased physical activity, and pain."
What are the risks associated with Low-dose naltrexone?
"Power team rates the safety of Low-dose naltrexone as being a 2. In clinical research, Phase 2 trials support the safety of a medication but not its efficacy."
Could you please compare and contrast this clinical trial to others that have been completed with Low-dose naltrexone?
"Currently, there are 52 different ongoing clinical trials related to Low-dose naltrexone. Of these, 16 have reached Phase 3. Many of the trials for Low-dose naltrexone are based in New york; however, there are a total of 175 locations running similar studies."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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