IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone
NCT ID: NCT04313972
Last Updated: 2025-03-07
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE4
Total Enrollment
3 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-09-07
Study Completion Date
2023-02-23
Brief Summary
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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.
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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Detailed Description
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Conditions
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Interstitial Cystitis
Painful Bladder Syndrome
Bladder Pain Syndrome
Low Dose Naltrexone
Low-dose Naltrexone
Naltrexone
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Low-dose naltrexone
2mg low-dose naltrexone capsules
Group Type
EXPERIMENTAL
low-dose naltrexone
Intervention Type
DRUG
2mg of low-dose naltrexone nightly for 2 weeks, then 4mg of low-dose naltrexone nightly for 4 weeks
Placebo
Placebo capsules
Group Type
PLACEBO_COMPARATOR
Placebo oral tablet
Intervention Type
DRUG
1 capsule nighty for 2 weeks, then 2 capsules nightly for 4 weeks
Interventions
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low-dose naltrexone
2mg of low-dose naltrexone nightly for 2 weeks, then 4mg of low-dose naltrexone nightly for 4 weeks
Intervention Type
DRUG
Placebo oral tablet
1 capsule nighty for 2 weeks, then 2 capsules nightly for 4 weeks
Intervention Type
DRUG
Eligibility Criteria
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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 provide a blood sample to evaluate liver enzymes
8. Able to attend research visits
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 provide a blood sample to evaluate liver enzymes
8. 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 (aspartate aminotransferase) \> 32, ALT (alanine transaminase) \> 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 (Urinary Tract Infection) 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.
2. Patients with known liver disease, including total bilirubin \>1.2, AST (aspartate aminotransferase) \> 32, ALT (alanine transaminase) \> 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 (Urinary Tract Infection) 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
110 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Endeavor Health
OTHER
Sponsor Role
lead
Responsible Party
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Ghazaleh Rostami Nia
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Center for Pelvic Health at the NorthShore University HealthSystem
Skokie, Illinois, United States
Site Status
Countries
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United States
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Clauw 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.
Reference Type
BACKGROUND
Tripp 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.
Reference Type
BACKGROUND
Nickel 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.
Reference Type
BACKGROUND
Peters 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.
Reference Type
BACKGROUND
Propert 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.
Reference Type
BACKGROUND
Oh-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.
Reference Type
BACKGROUND
O'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.
Reference Type
BACKGROUND
Korting 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.
Reference Type
BACKGROUND
Parsons 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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
van Ophoven A, Pokupic S, Heinecke A, Hertle L. A prospective, randomized, placebo controlled, double-blind study of amitriptyline for the treatment of interstitial cystitis. J Urol. 2004 Aug;172(2):533-6. doi: 10.1097/01.ju.0000132388.54703.4d.
Reference Type
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.
Reference Type
BACKGROUND
Lee B, Elston DM. The uses of naltrexone in dermatologic conditions. J Am Acad Dermatol. 2019 Jun;80(6):1746-1752. doi: 10.1016/j.jaad.2018.12.031. Epub 2018 Dec 21.
Reference Type
BACKGROUND
Tortelly VD, De Mattos T, Fernandes LSA, Nunes BEM, Melo DF. Low-dose naltrexone: a novel adjunctive treatment in symptomatic alopecias? Dermatol Online J. 2019 Aug 15;25(8):13030/qt6j45h81f.
Reference Type
BACKGROUND
Zashin S. Sjogren's Syndrome: Clinical Benefits of Low-dose Naltrexone Therapy. Cureus. 2019 Mar 11;11(3):e4225. doi: 10.7759/cureus.4225.
Reference Type
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.
Reference Type
BACKGROUND
Jaros J, Lio P. Low Dose Naltrexone in Dermatology. J Drugs Dermatol. 2019 Mar 1;18(3):235-238.
Reference Type
BACKGROUND
Cui X, Jing X, Lutgendorf SK, Bradley CS, Schrepf A, Erickson BA, Magnotta VA, Ness TJ, Kreder KJ, O'Donnell MA, Luo Y. Cystitis-induced bladder pain is Toll-like receptor 4 dependent in a transgenic autoimmune cystitis murine model: a MAPP Research Network animal study. Am J Physiol Renal Physiol. 2019 Jul 1;317(1):F90-F98. doi: 10.1152/ajprenal.00017.2019. Epub 2019 May 15.
Reference Type
BACKGROUND
Suskind AM, Berry SH, Suttorp MJ, Elliott MN, Hays RD, Ewing BA, Clemens JQ. Health-related quality of life in patients with interstitial cystitis/bladder pain syndrome and frequently associated comorbidities. Qual Life Res. 2013 Sep;22(7):1537-41. doi: 10.1007/s11136-012-0285-5. Epub 2012 Oct 7.
Reference Type
BACKGROUND
Toljan K, Vrooman B. Low-Dose Naltrexone (LDN)-Review of Therapeutic Utilization. Med Sci (Basel). 2018 Sep 21;6(4):82. doi: 10.3390/medsci6040082.
Reference Type
BACKGROUND
Oaks Z, Stage A, Middleton B, Faraone S, Johnson B. Clinical utility of the cold pressor test: evaluation of pain patients, treatment of opioid-induced hyperalgesia and fibromyalgia with low dose naltrexone. Discov Med. 2018 Nov;26(144):197-206.
Reference Type
BACKGROUND
Patten DK, Schultz BG, Berlau DJ. The Safety and Efficacy of Low-Dose Naltrexone in the Management of Chronic Pain and Inflammation in Multiple Sclerosis, Fibromyalgia, Crohn's Disease, and Other Chronic Pain Disorders. Pharmacotherapy. 2018 Mar;38(3):382-389. doi: 10.1002/phar.2086. Epub 2018 Feb 23.
Reference Type
BACKGROUND
Parkitny L, Younger J. Reduced Pro-Inflammatory Cytokines after Eight Weeks of Low-Dose Naltrexone for Fibromyalgia. Biomedicines. 2017 Apr 18;5(2):16. doi: 10.3390/biomedicines5020016.
Reference Type
BACKGROUND
Hota D, Srinivasan A, Dutta P, Bhansali A, Chakrabarti A. Off-Label, Low-Dose Naltrexone for Refractory Painful Diabetic Neuropathy. Pain Med. 2016 Apr;17(4):790-1. doi: 10.1093/pm/pnv009. Epub 2015 Dec 7. No abstract available.
Reference Type
BACKGROUND
Younger J, Noor N, McCue R, Mackey S. Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis Rheum. 2013 Feb;65(2):529-38. doi: 10.1002/art.37734.
Reference Type
BACKGROUND
Ramanathan S, Panksepp J, Johnson B. Is fibromyalgia an endocrine/endorphin deficit disorder? Is low dose naltrexone a new treatment option? Psychosomatics. 2012 Nov-Dec;53(6):591-4. doi: 10.1016/j.psym.2011.11.006. Epub 2012 Apr 4. No abstract available.
Reference Type
BACKGROUND
de Oliveira MG, Monica FZ, Calmasini FB, Alexandre EC, Tavares EBG, Soares AG, Costa SKP, Antunes E. Deletion or pharmacological blockade of TLR4 confers protection against cyclophosphamide-induced mouse cystitis. Am J Physiol Renal Physiol. 2018 Sep 1;315(3):F460-F468. doi: 10.1152/ajprenal.00100.2018. Epub 2018 May 2.
Reference Type
BACKGROUND
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
Reference Type
BACKGROUND
Ghai B, Bansal D, Hota D, Shah CS. Off-label, low-dose naltrexone for refractory chronic low back pain. Pain Med. 2014 May;15(5):883-4. doi: 10.1111/pme.12345. No abstract available.
Reference Type
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.
Reference Type
BACKGROUND
Chopra P, Cooper MS. Treatment of Complex Regional Pain Syndrome (CRPS) using low dose naltrexone (LDN). J Neuroimmune Pharmacol. 2013 Jun;8(3):470-6. doi: 10.1007/s11481-013-9451-y. Epub 2013 Apr 2.
Reference Type
BACKGROUND
Frech T, Novak K, Revelo MP, Murtaugh M, Markewitz B, Hatton N, Scholand MB, Frech E, Markewitz D, Sawitzke AD. Low-dose naltrexone for pruritus in systemic sclerosis. Int J Rheumatol. 2011;2011:804296. doi: 10.1155/2011/804296. Epub 2011 Sep 12.
Reference Type
BACKGROUND
Cree BA, Kornyeyeva E, Goodin DS. Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis. Ann Neurol. 2010 Aug;68(2):145-50. doi: 10.1002/ana.22006.
Reference Type
BACKGROUND
Sharafaddinzadeh N, Moghtaderi A, Kashipazha D, Majdinasab N, Shalbafan B. The effect of low-dose naltrexone on quality of life of patients with multiple sclerosis: a randomized placebo-controlled trial. Mult Scler. 2010 Aug;16(8):964-9. doi: 10.1177/1352458510366857. Epub 2010 Jun 9.
Reference Type
BACKGROUND
Younger J, Mackey S. Fibromyalgia symptoms are reduced by low-dose naltrexone: a pilot study. Pain Med. 2009 May-Jun;10(4):663-72. doi: 10.1111/j.1526-4637.2009.00613.x. Epub 2009 Apr 22.
Reference Type
BACKGROUND
Gironi M, Martinelli-Boneschi F, Sacerdote P, Solaro C, Zaffaroni M, Cavarretta R, Moiola L, Bucello S, Radaelli M, Pilato V, Rodegher M, Cursi M, Franchi S, Martinelli V, Nemni R, Comi G, Martino G. A pilot trial of low-dose naltrexone in primary progressive multiple sclerosis. Mult Scler. 2008 Sep;14(8):1076-83. doi: 10.1177/1352458508095828.
Reference Type
BACKGROUND
Kariv R, Tiomny E, Grenshpon R, Dekel R, Waisman G, Ringel Y, Halpern Z. Low-dose naltreoxone for the treatment of irritable bowel syndrome: a pilot study. Dig Dis Sci. 2006 Dec;51(12):2128-33. doi: 10.1007/s10620-006-9289-8. Epub 2006 Nov 1.
Reference Type
BACKGROUND
Majumdar SR, Roe MT, Peterson ED, Chen AY, Gibler WB, Armstrong PW. Better outcomes for patients treated at hospitals that participate in clinical trials. Arch Intern Med. 2008 Mar 24;168(6):657-62. doi: 10.1001/archinternmed.2007.124.
Reference Type
BACKGROUND
Meske DS, Lawal OD, Elder H, Langberg V, Paillard F, Katz N. Efficacy of opioids versus placebo in chronic pain: a systematic review and meta-analysis of enriched enrollment randomized withdrawal trials. J Pain Res. 2018 May 3;11:923-934. doi: 10.2147/JPR.S160255. eCollection 2018.
Reference Type
BACKGROUND
Hale M, Khan A, Kutch M, Li S. Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain. Curr Med Res Opin. 2010 Jun;26(6):1505-18. doi: 10.1185/03007995.2010.484723.
Reference Type
BACKGROUND
Schwartz S, Etropolski M, Shapiro DY, Okamoto A, Lange R, Haeussler J, Rauschkolb C. Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial. Curr Med Res Opin. 2011 Jan;27(1):151-62. doi: 10.1185/03007995.2010.537589.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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https://www-uptodate-com.proxy.uchicago.edu/contents/amitriptyline-drug-
Amitriptyline: Drug information. Accessed 10/29/2019
https://www-uptodate-com.proxy.uchicago.edu/contents/management-of-interstitial-cystitis-bladder-pain-syndrome?source=history_widget#H285129
Management of interstitial cystitis/bladder pain syndrome. Uptpdate. Accessed 12/5/2019
Other Identifiers
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EH20-127
Identifier Type: -
Identifier Source: org_study_id
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PHASE1/PHASE2
Efficacy and Safety of AQX-1125 in IC/BPS
NCT01882543
COMPLETED
PHASE2
Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome
NCT04401176
COMPLETED
PHASE2
Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome
NCT06285214
COMPLETED
PHASE1
Auricular Acupressure Therapy for Patients With IC/BPS
NCT05857020
WITHDRAWN
NA
Interstitial Cystitis (IC)-Like Findings With Hydrodistension
NCT02547298
TERMINATED
Intranasal Fentanyl as an Analgesic for Cystoscopic Procedures
NCT01708122
COMPLETED
PHASE4
Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment
NCT06299683
RECRUITING
NA
A Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial Cystitis
NCT02787083
TERMINATED
PHASE3
A Randomized Study Comparing Placebo and ASP3652 in the Treatment of Women With Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC)
NCT01613586
COMPLETED
PHASE2
Interstitial Cystitis and Urinary pH
NCT03024619
COMPLETED
Platelet Enriched Plasma for Treatment of Interstitial Cystitis
NCT04118946
UNKNOWN
PHASE1/PHASE2
Prospective Trial Comparing Intravesical Chondroitin Sulphate 2% and DMSO in the Treatment of PBS/Interstitial Cystitis
NCT04268810
TERMINATED
PHASE4
Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS
NCT05737121
RECRUITING
PHASE2
Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome
NCT04275297
COMPLETED
NA
Phenotyping Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) by Intravesical Contrast Enhanced - Magnetic Resonance Imaging (ICE-MRI) Bladder Permeability Assay
NCT05811377
COMPLETED
EARLY_PHASE1
The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)
NCT01569438
TERMINATED
PHASE2
A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome
NCT00999518
TERMINATED
PHASE2
Clinical Trial Comparing Two Bladder Instillations for IC/BPS
NCT03463915
COMPLETED
PHASE3
A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized Vulvodynia
NCT01048177
WITHDRAWN
PHASE2
Interstitial Cystitis
NCT00056251
COMPLETED
PHASE2