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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose naltrexone | Experimental | 2mg low-dose naltrexone capsules |
|
| Placebo | Placebo Comparator | Placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-dose naltrexone | Drug | 2mg of low-dose naltrexone nightly for 2 weeks, then 4mg of low-dose naltrexone nightly for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Pelvic Health at the NorthShore University HealthSystem | Skokie | Illinois | 60076 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22177158 | Background | 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. | |
| 21497847 |
| Label | URL |
|---|---|
| Amitriptyline: Drug information. Accessed 10/29/2019 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low-dose Naltrexone | 2mg low-dose naltrexone capsules low-dose naltrexone: 2mg of low-dose naltrexone nightly for 2 weeks, then 4mg of low-dose naltrexone nightly for 4 weeks |
| FG001 | Placebo | Placebo capsules Placebo oral tablet: 1 capsule nighty for 2 weeks, then 2 capsules nightly for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low-dose Naltrexone | 2mg low-dose naltrexone capsules low-dose naltrexone: 2mg of low-dose naltrexone nightly for 2 weeks, then 4mg of low-dose naltrexone nightly for 4 weeks |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Excluding one participant who withdrew from the study. | Posted | Number | score on a scale | six weeks |
|
At two weeks and at four weeks, an average up to six weeks
No adverse event was recorded for the three participants enrolled in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low-dose Naltrexone | 2mg low-dose naltrexone capsules low-dose naltrexone: 2mg of low-dose naltrexone nightly for 2 weeks, then 4mg of low-dose naltrexone nightly for 4 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Urogynecology Research Coordinator | Endeavor Health | 847-570-4729 | JLee5@northshore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2021 | Nov 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Placebo oral tablet | Drug | 1 capsule nighty for 2 weeks, then 2 capsules nightly for 4 weeks |
|
| 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. | 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. | 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. | 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. | 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. | 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. | six weeks |
| Medication Tolerability | The percentage of patients who discontinue the study medication measured by the tolerability survey. | 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. | six weeks |
| Hanno 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. |
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| 20303115 | Background | Foster 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. |
| 9598476 | Background | Parsons 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. |
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| 12913705 | Background | Sant GR, Propert KJ, Hanno PM, Burks D, Culkin D, Diokno AC, Hardy C, Landis JR, Mayer R, Madigan R, Messing EM, Peters K, Theoharides TC, Warren J, Wein AJ, Steers W, Kusek JW, Nyberg LM; Interstitial Cystitis Clinical Trials Group. A pilot clinical trial of oral pentosan polysulfate and oral hydroxyzine in patients with interstitial cystitis. J Urol. 2003 Sep;170(3):810-5. doi: 10.1097/01.ju.0000083020.06212.3d. |
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| 30917675 | Background | Trofimovitch D, Baumrucker SJ. Pharmacology Update: Low-Dose Naltrexone as a Possible Nonopioid Modality for Some Chronic, Nonmalignant Pain Syndromes. Am J Hosp Palliat Care. 2019 Oct;36(10):907-912. doi: 10.1177/1049909119838974. Epub 2019 Mar 27. |
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| Management of interstitial cystitis/bladder pain syndrome. Uptpdate. Accessed 12/5/2019 | View source |
Placebo capsules
Placebo oral tablet: 1 capsule nighty for 2 weeks, then 2 capsules nightly for 4 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Placebo capsules Placebo oral tablet: 1 capsule nighty for 2 weeks, then 2 capsules nightly for 4 weeks |
|
|
| Primary | 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. | Excluding one participant who withdrew from the study. | Posted | Number | score on a scale | six weeks |
|
|
|
| Secondary | 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. | Excluding one participant who withdrew from the study. | Posted | Number | score on a scale | prior to initiating treatment and at the conclusion of 6 weeks of treatment |
|
|
|
| Secondary | 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. | Excluding one participant who withdrew from the study. | Posted | Number | voids per day | prior to initiating treatment and at the conclusion of 6 weeks of treatment |
|
|
|
| Secondary | 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. | Excluding one participant who withdrew from the study. | Posted | Number | voids per night | prior to initiating treatment and at the conclusion of 6 weeks of treatment |
|
|
|
| Secondary | 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. | Excluding one participant who withdrew from the study. | Posted | Number | score on a scale | prior to initiating treatment and at the conclusion of 6 weeks of treatment |
|
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| Secondary | 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. | Excluding one participant who withdrew from the study. | Posted | Number | score on a scale | prior to initiating treatment and at the conclusion of 6 weeks of treatment |
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| Secondary | 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. | Excluding one participant who withdrew from the study. | Posted | Number | score on a scale | six weeks |
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| Secondary | 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. | Excluding one participant who withdrew from the study. | Posted | Count of Participants | Participants | six weeks |
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| Secondary | Medication Tolerability | The percentage of patients who discontinue the study medication measured by the tolerability survey. | Excluding one participant who withdrew from the study. | Posted | Count of Participants | Participants | six weeks |
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| Secondary | Number of Days With Pain Medications | The number of days with pain medication use while using LDN, as determined by a pain medication diary. | Excluding one participant who withdrew from the study. | Posted | Number | days | six weeks |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Placebo | Placebo capsules Placebo oral tablet: 1 capsule nighty for 2 weeks, then 2 capsules nightly for 4 weeks | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |