Interstitial CystitisPhase 4NCT04313972
IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone
A Phase 4 study testing low-dose naltrexone in people with Interstitial Cystitis and Painful Bladder Syndrome, run by Endeavor Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome
- What is being tested?
- low-dose naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2021to 23 Feb 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged eighteen and older
- 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)
- 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.
- Have had a cystoscopy in the last 6 months prior to study entry to rule out confounding conditions
- English speaking
- Working telephone number
- Able to provide a blood sample to evaluate liver enzymes
- Able to attend research visits
Who cannot join
- Patients under the age of 18
- Patients with known liver disease, including total bilirubin >1.2, AST (aspartate aminotransferase) > 32, ALT (alanine transaminase) > 54
- Patients with known kidney disease
- Patients who have thyroid disease and who are taking thyroid replacement medications
- Patients with known neurologic disease affecting bladder function
- Patients with known bladder or urethral cancer
Show all 23Show fewer
- Patients with bladder, urethral, or ureteral calculi
- Patients who have had a positive urine culture or a clinical UTI (Urinary Tract Infection) in the past 6 weeks
- Patients who are currently pregnant or breast feeding (15)
- Patients who are actively using opioid analgesics
- Patients with moderate-severe alcohol use disorder
- Patients who are actively using sleep aids
- 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.
- Patients who have had a known adverse reaction to naltrexone
- Patients who are acutely ill
- Patients who are diagnosed with a significant psychological comorbidity that would interfere with study participation (32)
- Patients who have had a bladder instillation or had oral medical treatment for IC/PBS in the past four weeks.
- Patients diagnosed with other chronic pelvic pain syndromes, such as endometriosis
- Patients who are unable to swallow pills/capsules
- Patients who have had previous treatment with low-dose naltrexone
- Patients who have previously scheduled surgeries or procedure during the study time period that would require analgesia.
- 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.
- Patients who are unwilling to have a serum blood test to assess serum transaminases and serum bilirubin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Pelvic Health at the NorthShore University HealthSystem
Skokie, Illinois, 60076
About this study
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
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.
Read more
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.
- Conditions
- Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome, Low Dose Naltrexone, Low-dose Naltrexone, Naltrexone
- Being tested
- low-dose naltrexone, Placebo oral tablet
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose naltrexoneDrug
2mg of low-dose naltrexone nightly for 2 weeks, then 4mg of low-dose naltrexone nightly for 4 weeks
Placebo oral tabletDrug
1 capsule nighty for 2 weeks, then 2 capsules nightly for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low-dose naltrexone | Experimental | 2mg low-dose naltrexone capsules Receives: Drug: low-dose naltrexone |
| Placebo | Placebo comparator | Placebo capsules Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interstitial Cystitis Symptom Index
The effect of LDN (low-dose naltrexone) in decreasing symptoms associated with IC/PBS (interstitial cystitis/painful bladder syndrome) 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.
Measured: six weeks
Visual Analog Scale
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 10, with lower scores indicating less pain.
Measured: six weeks
Secondary outcomes (9)
Change in Interstitial Cystitis Problem Index
The changes in IC/PBS associated problems when treating interstitial cystitis/painful bladder syndrome with low-dose naltrexone as scored by the Interstitial Cystitis Problem Index, prior to initiating treatment and at the conclusion of 6 weeks of treatment. Scores are from 0-16, with lower scores indicating a better score, with fewer problems associated with IC/PBS. The change was calculated from two time points as the value prior to initiating treatment minus the value at the conclusion of 6 weeks of treatment.
Measured: prior to initiating treatment and at the conclusion of 6 weeks of treatment
Change in Urinary Frequency
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. The change was calculated from two time points as the value prior to initiating treatment minus the value at the conclusion of 6 weeks of treatment.
Measured: prior to initiating treatment and at the conclusion of 6 weeks of treatment
Change in Number of Nocturia
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. The change was calculated from two time points as the value prior to initiating treatment minus the value at the conclusion of 6 weeks of treatment.
Measured: prior to initiating treatment and at the conclusion of 6 weeks of treatment
Change in Pelvic Pain and Urgency/Frequency Symptoms
The change in pelvic pain and urgency/frequency symptoms as measured on the Pelvic Pain and Urgency/Frequency Patient Symptom Scale, prior to initiating treatment and at the conclusion of 6 weeks of treatment. Scores can range from 0-23, with higher scores indicating more severe symptoms associated with IC/PBS. The change was calculated from two time points as the value prior to initiating treatment minus the value at the conclusion of 6 weeks of treatment.
Measured: prior to initiating treatment and at the conclusion of 6 weeks of treatment
Change in Pelvic Pain and Urgency/Frequency Bother
The change in pelvic pain and urgency/frequency bother as measured on the Pelvic Pain and Urgency/Frequency Patient Symptom Scale, prior to initiating treatment and at the conclusion of 6 weeks of treatment. Scores can range from 0-12, with higher values corresponding to more bother from IC/PBS symptoms. The change was calculated from two time points as the value prior to initiating treatment minus the value at the conclusion of 6 weeks of treatment.
Measured: prior to initiating treatment and at the conclusion of 6 weeks of treatment
Patient Perceived Quality of Life: SF-36
Patient perceived 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.
Measured: six weeks
Adverse Effects
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.
Measured: six weeks
Medication Tolerability
The percentage of patients who discontinue the study medication measured by the tolerability survey.
Measured: six weeks
Number of Days With Pain Medications
The number of days with pain medication use while using LDN, as determined by a pain medication diary.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start7 Sep 2021
- Primary completion23 Jan 2023
- Study completion23 Feb 2023
Why it stopped: There was a delay in recruitment initiation due to COVID-19 and internal logistical challenges. Following this delay, the principal investigator left the study site, and it was determined that the study should be terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghazaleh Rostami Nia, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313972
- Sponsor's protocol ID
- EH20-127
- Status last verified
- Feb 2025
- First submitted
- 16 Mar 2020
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Konkle KS, Berry SH, Elliott MN, Hilton L, Suttorp MJ, Clauw DJ, Clemens JQ. Comparison of an interstitial cystitis/bladder pain syndrome clinical cohort with symptomatic community women from the RAND Interstitial Cystitis Epidemiology study. J Urol. 2012 Feb;187(2):508-12. doi: 10.1016/j.juro.2011.10.040. Epub 2011 Dec 15.
PubMed 22177158Hanno PM, Burks DA, Clemens JQ, Dmochowski RR, Erickson D, Fitzgerald MP, Forrest JB, Gordon B, Gray M, Mayer RD, Newman D, Nyberg L Jr, Payne CK, Wesselmann U, Faraday MM; Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011 Jun;185(6):2162-70. doi: 10.1016/j.juro.2011.03.064. Epub 2011 Apr 16.
PubMed 21497847Clauw DJ, Schmidt M, Radulovic D, Singer A, Katz P, Bresette J. The relationship between fibromyalgia and interstitial cystitis. J Psychiatr Res. 1997 Jan-Feb;31(1):125-31. doi: 10.1016/s0022-3956(96)00051-9.
PubMed 9201654Tripp DA, Nickel JC, Wong J, Pontari M, Moldwin R, Mayer R, Carr LK, Doggweiler R, Yang CC, Mishra N, Nordling J. Mapping of pain phenotypes in female patients with bladder pain syndrome/interstitial cystitis and controls. Eur Urol. 2012 Dec;62(6):1188-94. doi: 10.1016/j.eururo.2012.05.023. Epub 2012 May 18.
PubMed 22633363Nickel JC, Tripp DA, Pontari M, Moldwin R, Mayer R, Carr LK, Doggweiler R, Yang CC, Mishra N, Nordling J. Interstitial cystitis/painful bladder syndrome and associated medical conditions with an emphasis on irritable bowel syndrome, fibromyalgia and chronic fatigue syndrome. J Urol. 2010 Oct;184(4):1358-63. doi: 10.1016/j.juro.2010.06.005. Epub 2010 Aug 17.
PubMed 20719340Peters K, Diokno A, Steinert B, Yuhico M, Mitchell B, Krohta S, Gillette B, Gonzalez J. The efficacy of intravesical Tice strain bacillus Calmette-Guerin in the treatment of interstitial cystitis: a double-blind, prospective, placebo controlled trial. J Urol. 1997 Jun;157(6):2090-4.
PubMed 9146587Propert KJ, Payne C, Kusek JW, Nyberg LM. Pitfalls in the design of clinical trials for interstitial cystitis. Urology. 2002 Nov;60(5):742-8. doi: 10.1016/s0090-4295(02)01775-2. No abstract available.
PubMed 12429288Oh-Oka H. Clinical Efficacy of 1-Year Intensive Systematic Dietary Manipulation as Complementary and Alternative Medicine Therapies on Female Patients With Interstitial Cystitis/Bladder Pain Syndrome. Urology. 2017 Aug;106:50-54. doi: 10.1016/j.urology.2017.02.053. Epub 2017 Apr 20.
PubMed 28435032O'Leary MP, Sant GR, Fowler FJ Jr, Whitmore KE, Spolarich-Kroll J. The interstitial cystitis symptom index and problem index. Urology. 1997 May;49(5A Suppl):58-63. doi: 10.1016/s0090-4295(99)80333-1.
PubMed 9146003Korting GE, Smith SD, Wheeler MA, Weiss RM, Foster HE Jr. A randomized double-blind trial of oral L-arginine for treatment of interstitial cystitis. J Urol. 1999 Feb;161(2):558-65.
PubMed 9915448Parsons CL, Benson G, Childs SJ, Hanno P, Sant GR, Webster G. A quantitatively controlled method to study prospectively interstitial cystitis and demonstrate the efficacy of pentosanpolysulfate. J Urol. 1993 Sep;150(3):845-8. doi: 10.1016/s0022-5347(17)35629-x.
PubMed 7688432Hanno 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.
Anderson VR, Perry CM. Pentosan polysulfate: a review of its use in the relief of bladder pain or discomfort in interstitial cystitis. Drugs. 2006;66(6):821-35. doi: 10.2165/00003495-200666060-00006.
PubMed 16706553Foster HE Jr, Hanno PM, Nickel JC, Payne CK, Mayer RD, Burks DA, Yang CC, Chai TC, Kreder KJ, Peters KM, Lukacz ES, FitzGerald MP, Cen L, Landis JR, Propert KJ, Yang W, Kusek JW, Nyberg LM; Interstitial Cystitis Collaborative Research Network. Effect of amitriptyline on symptoms in treatment naive patients with interstitial cystitis/painful bladder syndrome. J Urol. 2010 May;183(5):1853-8. doi: 10.1016/j.juro.2009.12.106. Epub 2010 Mar 29.
PubMed 20303115Parsons CL, Greenberger M, Gabal L, Bidair M, Barme G. The role of urinary potassium in the pathogenesis and diagnosis of interstitial cystitis. J Urol. 1998 Jun;159(6):1862-6; discussion 1866-7. doi: 10.1016/S0022-5347(01)63178-1.
PubMed 9598476
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04313972
- Acronym / sponsor ID
- EH20-127
- Conditions
- Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome, Low Dose Naltrexone, Low-dose Naltrexone, Naltrexone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There was a delay in recruitment initiation due to COVID-19 and internal logistical challenges. Following this delay, the principal investigator left the study site, and it was determined that the study should be terminated.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose naltrexone | Experimental | Drug: low-dose naltrexone2mg low-dose naltrexone capsules |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo capsules |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged eighteen and older
- 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)
- 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.
- Have had a cystoscopy in the last 6 months prior to study entry to rule out confounding conditions
- English speaking
Key exclusion criteria (23 listed)
- Patients under the age of 18
- Patients with known liver disease, including total bilirubin >1.2, AST (aspartate aminotransferase) > 32, ALT (alanine transaminase) > 54
- Patients with known kidney disease
- Patients who have thyroid disease and who are taking thyroid replacement medications
- Patients with known neurologic disease affecting bladder function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-dose naltrexone2mg of low-dose naltrexone nightly for 2 weeks, then 4mg of low-dose naltrexone nightly for 4 weeks | Drug | Low-dose naltrexone |
| Placebo oral tablet1 capsule nighty for 2 weeks, then 2 capsules nightly for 4 weeks | Drug | Placebo |
Primary outcome
Interstitial Cystitis Symptom Index
Time frame: six weeks
The effect of LDN (low-dose naltrexone) in decreasing symptoms associated with IC/PBS (interstitial cystitis/painful bladder syndrome) 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.
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 10, with lower scores indicating less pain.
9 secondary outcomes
Change in Interstitial Cystitis Problem Index
Time frame: prior to initiating treatment and at the conclusion of 6 weeks of treatment
Change in Urinary Frequency
Time frame: prior to initiating treatment and at the conclusion of 6 weeks of treatment
Change in Number of Nocturia
Time frame: prior to initiating treatment and at the conclusion of 6 weeks of treatment
Change in Pelvic Pain and Urgency/Frequency Symptoms
Time frame: prior to initiating treatment and at the conclusion of 6 weeks of treatment
Change in Pelvic Pain and Urgency/Frequency Bother
Time frame: prior to initiating treatment and at the conclusion of 6 weeks of treatment
Patient Perceived Quality of Life: SF-36
Time frame: six weeks
Adverse Effects
Time frame: six weeks
Medication Tolerability
Time frame: six weeks
Number of Days With Pain Medications
Time frame: six weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22177158Konkle KS, Berry SH, Elliott MN, Hilton L, Suttorp MJ, Clauw DJ, Clemens JQ. Comparison of an interstitial cystitis/bladder pain syndrome clinical cohort with symptomatic community women from the RAND Interstitial Cystitis Epidemiology study. J Urol. 2012 Feb;187(2):508-12. doi: 10.1016/j.juro.2011.10.040. Epub 2011 Dec 15.
- Background: PubMed 21497847Hanno PM, Burks DA, Clemens JQ, Dmochowski RR, Erickson D, Fitzgerald MP, Forrest JB, Gordon B, Gray M, Mayer RD, Newman D, Nyberg L Jr, Payne CK, Wesselmann U, Faraday MM; Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011 Jun;185(6):2162-70. doi: 10.1016/j.juro.2011.03.064. Epub 2011 Apr 16.
- Background: PubMed 9201654Clauw DJ, Schmidt M, Radulovic D, Singer A, Katz P, Bresette J. The relationship between fibromyalgia and interstitial cystitis. J Psychiatr Res. 1997 Jan-Feb;31(1):125-31. doi: 10.1016/s0022-3956(96)00051-9.
- Background: PubMed 22633363Tripp DA, Nickel JC, Wong J, Pontari M, Moldwin R, Mayer R, Carr LK, Doggweiler R, Yang CC, Mishra N, Nordling J. Mapping of pain phenotypes in female patients with bladder pain syndrome/interstitial cystitis and controls. Eur Urol. 2012 Dec;62(6):1188-94. doi: 10.1016/j.eururo.2012.05.023. Epub 2012 May 18.
- Background: PubMed 20719340Nickel JC, Tripp DA, Pontari M, Moldwin R, Mayer R, Carr LK, Doggweiler R, Yang CC, Mishra N, Nordling J. Interstitial cystitis/painful bladder syndrome and associated medical conditions with an emphasis on irritable bowel syndrome, fibromyalgia and chronic fatigue syndrome. J Urol. 2010 Oct;184(4):1358-63. doi: 10.1016/j.juro.2010.06.005. Epub 2010 Aug 17.
- Background: PubMed 9146587Peters K, Diokno A, Steinert B, Yuhico M, Mitchell B, Krohta S, Gillette B, Gonzalez J. The efficacy of intravesical Tice strain bacillus Calmette-Guerin in the treatment of interstitial cystitis: a double-blind, prospective, placebo controlled trial. J Urol. 1997 Jun;157(6):2090-4.
- Background: PubMed 12429288Propert KJ, Payne C, Kusek JW, Nyberg LM. Pitfalls in the design of clinical trials for interstitial cystitis. Urology. 2002 Nov;60(5):742-8. doi: 10.1016/s0090-4295(02)01775-2. No abstract available.
- Background: PubMed 28435032Oh-Oka H. Clinical Efficacy of 1-Year Intensive Systematic Dietary Manipulation as Complementary and Alternative Medicine Therapies on Female Patients With Interstitial Cystitis/Bladder Pain Syndrome. Urology. 2017 Aug;106:50-54. doi: 10.1016/j.urology.2017.02.053. Epub 2017 Apr 20.
- Background: PubMed 9146003O'Leary MP, Sant GR, Fowler FJ Jr, Whitmore KE, Spolarich-Kroll J. The interstitial cystitis symptom index and problem index. Urology. 1997 May;49(5A Suppl):58-63. doi: 10.1016/s0090-4295(99)80333-1.
- Background: PubMed 9915448Korting GE, Smith SD, Wheeler MA, Weiss RM, Foster HE Jr. A randomized double-blind trial of oral L-arginine for treatment of interstitial cystitis. J Urol. 1999 Feb;161(2):558-65.
- Background: PubMed 7688432Parsons CL, Benson G, Childs SJ, Hanno P, Sant GR, Webster G. A quantitatively controlled method to study prospectively interstitial cystitis and demonstrate the efficacy of pentosanpolysulfate. J Urol. 1993 Sep;150(3):845-8. doi: 10.1016/s0022-5347(17)35629-x.
- BackgroundHanno 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.
- Amitriptyline: Drug information. Accessed 10/29/2019Link provided by the sponsor.
- Management of interstitial cystitis/bladder pain syndrome. Uptpdate. Accessed 12/5/2019Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing low-dose naltrexone in people with Interstitial Cystitis and Painful Bladder Syndrome, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interstitial Cystitis Symptom Index (time frame: six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04313972, which also lists 46 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.