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IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone

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ClinicalTrials.gov Identifier: NCT04313972
Recruitment Status : Recruiting
First Posted : March 18, 2020
Last Update Posted : September 20, 2021
Sponsor:
Information provided by (Responsible Party):
Nani Moss, NorthShore University HealthSystem

Brief Summary:

Interstitial cystitis/painful bladder syndrome (IC/PBS) is a debilitating condition with symptoms of urinary urgency, frequency, nocturia (waking up at night to void), and pain, without evidence of urinary tract infection or other identifiable causes. IC/PBS often coexists with other chronic pain syndromes, such as irritable bowel syndrome, chronic fatigue syndrome, and fibromyalgia.

Several treatments exist for IC/PBS; some are not effective, others are time consuming for patients to receive, some can take weeks to months before they become effective, and many have risks associated with them. Low-dose naltrexone (LDN) has demonstrated improvement of symptoms in conditions associated with IC/PBS. LDN is defined as less than 5mg of naltrexone. Some adverse effects have been reported with LDN, the most common are vivid dreams, nightmares, and insomnia.

The investigators hypothesis LDN will have greater than 30% reduction in symptoms as defined by the Interstitial Cystitis Symptom Index in patients diagnosed with IC/PBS from baseline when compared to placebo. The 30% reduction in pain is a standard outcome measure in the pain literature. This improvement has been seen in prior studies where LDN was used to treat pain syndromes.

This will be a randomized double-blinded placebo-controlled prospective trial. Patients meeting diagnostic criteria for IC/PBS by American Urologic Association (AUA) guidelines will be eligible, and then must then meet all applicable inclusion and exclusion criteria. Study participants will sign a consent, complete several questionnaires, give a blood sample to measure liver function tests, and once at home, complete a 24-hour bladder diary.

Participants will be randomized to receive either placebo or study medication. Participants will be instructed to take one capsule nightly for two weeks, then increase to two capsules nightly for four weeks. They will be given a log to record the date and time they take the medication. All study participants will also receive first-line behavioral therapy for IC/PBS of a bladder diet and bladder drills.

After six weeks, participants will complete a second bladder diary. They will then complete the exit study questionnaires, have a second liver function test, return any unused medication, and meet with their doctor to discuss conventional treatment options for IC/PBS.


Condition or disease Intervention/treatment Phase
Interstitial Cystitis Painful Bladder Syndrome Bladder Pain Syndrome Low Dose Naltrexone Low-dose Naltrexone Naltrexone Drug: low-dose naltrexone Drug: Placebo oral tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone, the Effect of Low Dose Naltrexone on Symptoms and Pain of Patients With Interstitial Cystitis/Painful Bladder Syndrome a Randomized Placebo-controlled Prospective Trial
Actual Study Start Date : September 7, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low-dose naltrexone
2mg low-dose naltrexone capsules
Drug: low-dose naltrexone
2mg of low-dose naltrexone nightly for 2 weeks, then 4mg of low-dose naltrexone nightly for 4 weeks

Placebo Comparator: Placebo
Placebo capsules
Drug: Placebo oral tablet
1 capsule nighty for 2 weeks, then 2 capsules nightly for 4 weeks




Primary Outcome Measures :
  1. Interstitial Cystitis Symptom Index [ Time Frame: six weeks ]
    The effect of LDN in decreasing symptoms associated with IC/PBS when treating with low-dose naltrexone as scored by the Interstitial Cystitis Symptom Index as compared to placebo. Scores are from 0 to 20, with lower scores indicating less symptoms associated with IC/PBS.

  2. Visual analog scale [ Time Frame: six weeks ]
    The effect of LDN in decreasing pain associated with IC/PBS when treating with low-dose naltrexone as scored by visual analog scale as compared with placebo. Scores are from 0 to 100, with lower scores indicating less pain.


Secondary Outcome Measures :
  1. Interstitial Cystitis Problem Index [ Time Frame: six weeks ]
    The decrease in IC/PBS associated problems when treating interstitial cystitis/painful bladder syndrome with low-dose naltrexone as scored by the Interstitial Cystitis Problem Index. Scores are from 0-16, with lower scores indicating a better score, with fewer problems associated with IC/PBS.

  2. Urinary frequency [ Time Frame: six weeks ]
    The change in number of patient voids during the day when comparing LDN against placebo as determined from 24 hour bladder diary performed by patient prior to initiating treatment, and at the conclusion of 6 weeks of treatment.

  3. Nocturia [ Time Frame: six weeks ]
    The change in number of patient voids during at night when comparing LDN against placebo as determined from 24 hour bladder diary performed by patient prior to initiating treatment, and at the conclusion of 6 weeks of treatment.

  4. pelvic pain and urgency/frequency symptoms [ Time Frame: six weeks ]
    The change in pelvic pain and urgency/frequency symptoms as measured on the Pelvic Pain and Urgency/Frequency Patient Symptom Scale. Scores can range from 0-23, with higher scores indicating more severe symptoms associated with IC/PBS.

  5. pelvic pain and urgency/frequency bother [ Time Frame: six weeks ]
    The change in pelvic pain and urgency/frequency bother as measured on the Pelvic Pain and Urgency/Frequency Patient Symptom Scale. Scores can range from 0-12, with higher values corresponding to more bother from IC/PBS symptoms.

  6. Patient perceived changes in quality of life: SF-36 [ Time Frame: six weeks ]
    Patient perceived changes in quality of life as measured by the medical outcomes study short form 36 (SF-36). Higher scores indicate a more favorable health status. There are 8 subscales, which when averaged, include a score from 0-100.

  7. Adverse effects [ Time Frame: 6 weeks ]
    The percentage of patients complaining of adverse effects from LDN including vivid dreams, nightmares, insomnia, GI disturbances such as stomach cramps or diarrhea, agitation, anxiety, flu-like symptoms and headaches.

  8. Medication tolerability [ Time Frame: 6 weeks ]
    Patient tolerability of low-dose naltrexone using a tolerability survey, as well as instructing the patient to return any remaining medication at the end of the 6 week study period

  9. Change in pain medications [ Time Frame: 6 weeks ]
    The decrease in use of pain medications while using LDN as determined by a pain medication diary



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients aged eighteen and older
  2. Meet criteria for IC/PBS as defined by the American Urology Association as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms or more than six weeks duration, in the absence of infection or other identifiable causes" (8)
  3. Newly diagnosed and treatment naïve for IC/PBS or previously diagnosed with IC/PBS, but who have no received treatment in the past four weeks. Patient who use anti-inflammatory medication on an as needed basis in the four weeks prior to the study will be included.
  4. Have had a cystoscopy in the last 6 months prior to study entry to rule out confounding conditions
  5. English speaking
  6. Working telephone number
  7. Able to attend research visits

Exclusion Criteria:

  1. Patients under the age of 18
  2. Patients with known liver disease, including total bilirubin >1.2, AST> 32, ALT> 54
  3. Patients with known kidney disease
  4. Patients who have thyroid disease and who are taking thyroid replacement medications
  5. Patients with known neurologic disease affecting bladder function
  6. Patients with known bladder or urethral cancer
  7. Patients with bladder, urethral, or ureteral calculi
  8. Patients who have had a positive urine culture or a clinical UTI in the past 6 weeks
  9. Patients who are currently pregnant or breast feeding (15)
  10. Patients who are actively using opioid analgesics
  11. Patients with moderate-severe alcohol use disorder
  12. Patients who are actively using sleep aids
  13. Patients who are regularly using anti-inflammatory medications, such as daily Celebrex for arthritis. Those who use an anti-inflammatory medication on an as needed basis may use the medication prior to enrollment in the study.
  14. Patients who have had a known adverse reaction to naltrexone
  15. Patients who are acutely ill
  16. Patients who are diagnosed with a significant psychological comorbidity that would interfere with study participation (32)
  17. Patients who have had a bladder instillation or had oral medical treatment for IC/PBS in the past four weeks.
  18. Patients diagnosed with other chronic pelvic pain syndromes, such as endometriosis
  19. Patients who are unable to swallow pills/capsules
  20. Patients who have had previous treatment with low-dose naltrexone
  21. Patients who have previously scheduled surgeries or procedure during the study time period that would require analgesia.
  22. Patients who are sexually active and of childbearing potential who are unwilling to use an established and reliable form of contraception for the duration of the study.
  23. Patients who are unwilling to have a serum blood test to assess serum transaminases and serum bilirubin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04313972


Contacts
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Contact: Nani P Moss, MD, MPH 224-251-2374 nmoss2@northshore.org
Contact: Roger P Goldberg, MD, MPH 224-251-2374 rgoldberg@northshore.org

Locations
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United States, Illinois
Center for Pelvic Health at the NorthShore University HealthSystem Recruiting
Skokie, Illinois, United States, 60076
Contact: Nani Moss, MD MPH    224-251-2374      
Sponsors and Collaborators
NorthShore University HealthSystem
Additional Information:
Publications:
Hanno PM, Wein AJ, Kavoussi LR, Partin AW, Peters C, eds. Bladder pain syndrome (interstitial cystitis) and related disorder. 11th ed. Campbell-Walsh urology. Inc Philadelphia, PA: Elsevier; 2016: 334-370.

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Responsible Party: Nani Moss, Principal Investigator, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT04313972    
Other Study ID Numbers: EH20-127
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Syndrome
Pain
Disease
Pathologic Processes
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents