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Study terminated due to early participant drop out
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Interstitial cystitis/Bladder Pain Syndrome (IC/PBS) is a constellation of symptoms of pelvic discomfort that includes both bladder-related pain as well as urinary frequency, urgency, and nocturia in the absence of an identifiable etiology that affects likely more than 5.4 million patients in the United States. There is a significant overlap in patients with IC/PBS and those with fibromyalgia and chronic pelvic pain syndrome. Low-dose naltrexone (LDN) has been shown to be effective for the treatment of chronic pain conditions.
The primary aim of this study is to evaluate if LDN improves pain scores and lower urinary tract symptoms in patients with IC/PBS. A secondary aim is to show that it has a low adverse event profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose naltrexone | Active Comparator | 4.5mg of naltrexone to be taken one hour prior to bedtime nightly for 8 weeks. |
|
| Placebo | Placebo Comparator | Placebo tablet (sugar-pill) to be taken one hour prior to bedtime nightly for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone | Drug | 4.5mg tab (low-dose) nightly |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The Numeric Rating Scale of Pain | The Numeric Rating Scale (NRS) of Pain uses an 11-point likert scale. Scores ranges from a minimum of 0 (No pain) to a maximum of 10 (Worst Pain Imaginable). Higher scores indicate greater pain intensityThe proportion of subjects in the LDN and placebo groups that are responders with greater than 20% reductions in the worst daily Numeric Rating Scale of Pain scores after 8 weeks of treatment. | Will compare a 7-day average of pre-intervention Numeric Rating Scale of Pain scores to the 7-day average of post-intervention Numeric Rating Scale of Pain Scores after week 8 of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brief Pain Inventory Score | The Brief Pain Inventory score ranges from a minimum of 0 to a maximum of 10, with higher scores indicating worse pain intensity. | Comparing the average of 7 days of scores reported pre-intervention and the average of 7 days of score reported 8 weeks after intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig V Comiter, MD | Stanford University | Principal Investigator |
| Phil Hanno, MD | Stanford University | Principal Investigator |
| Jennifer M Hah, MD, MS | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Health Care | Stanford | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24526250 | Background | Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014 Apr;33(4):451-9. doi: 10.1007/s10067-014-2517-2. Epub 2014 Feb 15. |
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Should the study result be positive or promising, we would undertake a larger trial at which point we can reassess the sharing of IPD.
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5 participants did not complete the baseline assessments required before randomization and were excluded from the study before assignment to groups.
Patients were screened for eligibility and consented if eligible. Individuals who are consented are considered enrolled under the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low-dose Naltrexone | 4.5mg of naltrexone to be taken one hour prior to bedtime nightly for 8 weeks. Naltrexone: 4.5mg tab (low-dose) nightly |
| FG001 | Placebo | Placebo tablet (sugar-pill) to be taken one hour prior to bedtime nightly for 8 weeks. Placebo: 1 tab nightly |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low-dose Naltrexone | 4.5mg of naltrexone to be taken one hour prior to bedtime nightly for 8 weeks. Naltrexone: 4.5mg tab (low-dose) nightly |
| BG001 | Placebo | Placebo tablet (sugar-pill) to be taken one hour prior to bedtime nightly for 8 weeks. Placebo: 1 tab nightly |
| 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 | The Numeric Rating Scale of Pain | The Numeric Rating Scale (NRS) of Pain uses an 11-point likert scale. Scores ranges from a minimum of 0 (No pain) to a maximum of 10 (Worst Pain Imaginable). Higher scores indicate greater pain intensityThe proportion of subjects in the LDN and placebo groups that are responders with greater than 20% reductions in the worst daily Numeric Rating Scale of Pain scores after 8 weeks of treatment. | Participants who completed the follow-up assessments. | Posted | Count of Participants | Participants | Will compare a 7-day average of pre-intervention Numeric Rating Scale of Pain scores to the 7-day average of post-intervention Numeric Rating Scale of Pain Scores after week 8 of treatment. |
|
Adverse event data were collected for each patient over 8 weeks.
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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 | 4.5mg of naltrexone to be taken one hour prior to bedtime nightly for 8 weeks. Naltrexone: 4.5mg tab (low-dose) nightly |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
Early termination leading to small number of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Hah | Stanford University | 650-723-6238 | sparklelab@stanford.edu |
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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 | Apr 23, 2021 | Jun 5, 2025 | 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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Randomized placebo-controlled pilot study
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Participants will be randomized on a 1:1 ratio to either LDN or placebo. The randomization sequence will be logged by the study coordinator in a REDCap randomization log blinded to other research staff and clinical team and outcome assessors.
| Drug |
1 tab nightly |
|
| Voiding Diary |
The Voiding Diary assesses the frequency and amount an individual voids over the course of a 24 hour period. Study subjects indicate number of times they void in an hour and how much they urinate. Study subjects complete daily voiding diaries over the course of a 7 day period before and after the intervention period. Voiding frequency in a 24 hour period was assessed with possible range between 0 to 24 times per day. Participants were asked to complete a 7-day voiding diary at baseline and after 8 weeks of treatment. The average voiding frequency at baseline was compared to follow-up after 8 weeks of treatment. |
| Prior to treatment and after 8 weeks of treatment. |
| Change in Bladder Pain/Interstitial Cystitis Symptom Score | Total score ranges from 0 to 38. Higher values represent more symptoms of bladder pain associated with interstitial cystitis. | At pre-intervention to week 8 |
| Change in O'Leary Sant Symptom Scores | Scores range from 0-20 with higher scores representing more frequency of symptoms associated with interstitial cystitis such as urgency, frequency, nocturia (getting up at night to urinate), and pain or burning in the bladder. | At pre-intervention to week 8 |
| Change in O'Leary Sant Problem Indices Scores | Score ranges from 0 to 16 with higher scores representing that symptoms of interstitial cystitis are more problematic to the person with interstitial cystitis. | At pre-intervention to week 8 |
| Change in Global Response Assessment Scale Score | Patient-reported outcome measure. 7-point scale (ranging from markedly worse -3 to markedly improved +3), used to evaluate overall symptom change after treatment. | At pre-intervention to week 8 |
| Change in PROMIS Pain Behavior Score | Standardized metric (mean 50, standard deviation 10) assessing observable pain indicators, ranging from 20 to 80, with higher scores indicating more severe pain behavior. | At pre-intervention to week 8 |
| Change in PROMIS Physical Function Score | Standardized metric (mean 50, standard deviation 10) assessing self-reported capability, ranging from 20 to 80, with higher scores indicating better physical function | At pre-intervention to week 8 |
| Change in PROMIS Sleep Dysfunction Score | Standardized metric (mean 50, standard deviation 10) used to quantify self-reported sleep quality, depth, and restoration, ranging from 20 to 80, with a higher score indicating greater sleep disturbance. | At pre-intervention to week 8 |
| Change in PROMIS Sleep-Related Impairment | Sleep-related Impairment (SRI) score is a standardized, self-reported measure evaluating daytime alertness, sleepiness, and functional limitations over the past 7 days. It uses a T-score metric (mean of 50, standard deviation of 10), where higher scores indicate greater impairment. Scores range from 20-80. | At pre-intervention to week 8 |
| Change in PROMIS Pain Interference Score | The PROMIS Pain Interference (PI) score measures how much pain hinders a person's daily life-including physical, mental, emotional, and social activities-using a T-score metric where 50 is the average, and higher scores (e.g., 60+) indicate greater, more severe interference. Scores range from 20-80 | At pre-intervention to week 8 |
| Change in PROMIS Fatigue Score | The PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue score is a validated tool measuring the intensity, frequency, and impact of tiredness on daily life over the past seven days. It uses a T-score metric (mean=50, SD=10) where higher scores (e.g., 60+) indicate greater, more severe fatigue. Scores range from 20 to 80. | At pre-intervention to week 8 |
| Change in PROMIS Anxiety Score | Standardized metric (mean 50, standard deviation 10) assessing self-reported fear, anxious misery, and hyperarousal over the past 7 days, ranging from 20 to 80, with higher scores indicating more severe anxiety. | At pre-intervention to week 8 |
| Change in PROMIS Depression Score | Standardized metric (mean 50, standard deviation 10) assessing mood, self-view, and social cognition, ranging from 20 to 80, with higher scores indicating more severe depressive symptoms. | At pre-intervention to week 8 |
| 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 |
|
| Brief Pain Inventory Worst Pain | 0 to 10 numerical rating scale where 0 is no pain and 10 is pain as bad as you can imagine | Mean | Standard Deviation | units on a scale |
|
| OG001 | Placebo | Placebo tablet (sugar-pill) to be taken one hour prior to bedtime nightly for 8 weeks. Placebo: 1 tab nightly |
|
|
| Secondary | Change in Brief Pain Inventory Score | The Brief Pain Inventory score ranges from a minimum of 0 to a maximum of 10, with higher scores indicating worse pain intensity. | Participants who completed the follow-up assessments. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Comparing the average of 7 days of scores reported pre-intervention and the average of 7 days of score reported 8 weeks after intervention. |
|
|
|
| Secondary | Voiding Diary | The Voiding Diary assesses the frequency and amount an individual voids over the course of a 24 hour period. Study subjects indicate number of times they void in an hour and how much they urinate. Study subjects complete daily voiding diaries over the course of a 7 day period before and after the intervention period. Voiding frequency in a 24 hour period was assessed with possible range between 0 to 24 times per day. Participants were asked to complete a 7-day voiding diary at baseline and after 8 weeks of treatment. The average voiding frequency at baseline was compared to follow-up after 8 weeks of treatment. | Participants who completed the follow-up assessments. | Posted | Least Squares Mean | 95% Confidence Interval | voids per day | Prior to treatment and after 8 weeks of treatment. |
|
|
|
| Secondary | Change in Bladder Pain/Interstitial Cystitis Symptom Score | Total score ranges from 0 to 38. Higher values represent more symptoms of bladder pain associated with interstitial cystitis. | Participants who completed the follow-up assessments. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | At pre-intervention to week 8 |
|
|
|
| Secondary | Change in O'Leary Sant Symptom Scores | Scores range from 0-20 with higher scores representing more frequency of symptoms associated with interstitial cystitis such as urgency, frequency, nocturia (getting up at night to urinate), and pain or burning in the bladder. | Participants who completed the follow-up assessments. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | At pre-intervention to week 8 |
|
|
|
| Secondary | Change in O'Leary Sant Problem Indices Scores | Score ranges from 0 to 16 with higher scores representing that symptoms of interstitial cystitis are more problematic to the person with interstitial cystitis. | Participants who completed the follow-up assessments. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | At pre-intervention to week 8 |
|
|
|
| Secondary | Change in Global Response Assessment Scale Score | Patient-reported outcome measure. 7-point scale (ranging from markedly worse -3 to markedly improved +3), used to evaluate overall symptom change after treatment. | Participants who completed the follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | At pre-intervention to week 8 |
|
|
|
| Secondary | Change in PROMIS Pain Behavior Score | Standardized metric (mean 50, standard deviation 10) assessing observable pain indicators, ranging from 20 to 80, with higher scores indicating more severe pain behavior. | Participants who completed the follow-up assessments. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | At pre-intervention to week 8 |
|
|
|
| Secondary | Change in PROMIS Physical Function Score | Standardized metric (mean 50, standard deviation 10) assessing self-reported capability, ranging from 20 to 80, with higher scores indicating better physical function | Participants who completed the follow-up assessments. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | At pre-intervention to week 8 |
|
|
|
| Secondary | Change in PROMIS Sleep Dysfunction Score | Standardized metric (mean 50, standard deviation 10) used to quantify self-reported sleep quality, depth, and restoration, ranging from 20 to 80, with a higher score indicating greater sleep disturbance. | Participants who completed the follow-up assessments. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | At pre-intervention to week 8 |
|
|
|
| Secondary | Change in PROMIS Sleep-Related Impairment | Sleep-related Impairment (SRI) score is a standardized, self-reported measure evaluating daytime alertness, sleepiness, and functional limitations over the past 7 days. It uses a T-score metric (mean of 50, standard deviation of 10), where higher scores indicate greater impairment. Scores range from 20-80. | Participants who completed the follow-up assessments. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | At pre-intervention to week 8 |
|
|
|
| Secondary | Change in PROMIS Pain Interference Score | The PROMIS Pain Interference (PI) score measures how much pain hinders a person's daily life-including physical, mental, emotional, and social activities-using a T-score metric where 50 is the average, and higher scores (e.g., 60+) indicate greater, more severe interference. Scores range from 20-80 | Participants who completed the follow-up assessments. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | At pre-intervention to week 8 |
|
|
|
| Secondary | Change in PROMIS Fatigue Score | The PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue score is a validated tool measuring the intensity, frequency, and impact of tiredness on daily life over the past seven days. It uses a T-score metric (mean=50, SD=10) where higher scores (e.g., 60+) indicate greater, more severe fatigue. Scores range from 20 to 80. | Participants who completed the follow-up assessments. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | At pre-intervention to week 8 |
|
|
|
| Secondary | Change in PROMIS Anxiety Score | Standardized metric (mean 50, standard deviation 10) assessing self-reported fear, anxious misery, and hyperarousal over the past 7 days, ranging from 20 to 80, with higher scores indicating more severe anxiety. | Participants who completed the follow-up assessments. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | At pre-intervention to week 8 |
|
|
|
| Secondary | Change in PROMIS Depression Score | Standardized metric (mean 50, standard deviation 10) assessing mood, self-view, and social cognition, ranging from 20 to 80, with higher scores indicating more severe depressive symptoms. | Participants who completed the follow-up assessments. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | At pre-intervention to week 8 |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 3 |
| 16 |
| EG001 | Placebo | Placebo tablet (sugar-pill) to be taken one hour prior to bedtime nightly for 8 weeks. Placebo: 1 tab nightly | 0 | 8 | 0 | 8 | 1 | 8 |
| Medication Side Effect | Nervous system disorders | Systematic Assessment |
|
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| 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 |