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NCT05179460 Clinical Trial

A Study of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary Retinopathy

Interstitial Cystitis Clinical Trial

Official title:
Post-authorization Safety Study and Real-world Evaluation of the Use of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary Retinopathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05179460
Other study ID # CR109142
Secondary ID RWJ800077ICS4001
Status Completed
Phase
First received
Last updated
Start date October 26, 2021
Est. completion date May 20, 2022

Study information
Verified date December 2023
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate incidence and prevalence rates of the study endpoints (pigmentary maculopathy [PM]/ pigmentary retinopathy [PR]/Any, PM/PR/ pentosan polysulfate sodium [PPS], and PM/PR/Non-PPS) in relation to PPS exposure, and in participants with interstitial cystitis (IC) but not exposed to PPS; changes in visual acuity (VA) over time; participant treatment journey leading to PPS treatment, and potential risk factors associated with the occurrence of PM/PR/PPS.

Recruitment information / eligibility
Status Completed
Enrollment 2
Est. completion date May 20, 2022
Est. primary completion date May 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants must have at least 6 months baseline information prior to index date (this may apply to the relevant databases, if the study participants are identified and the outcomes are ascertained via multiple linked data source) For the pentosan polysulfate sodium (PPS) Cohort - Participants must have records in both the intelligent research in sight (IRIS) database and the closed claims portion of the Komodo claims database and have at least one record of PPS dispensing For the interstitial cystitis (IC) Cohort not exposed to PPS - Participants must have records in both the IRIS database and the closed claims portion of the claims database; have at least one diagnosis of IC; and have no record of PPS dispensing Exclusion Criteria: - Evaluated based on the Komodo database. Participants will be excluded from the study if they have no information on age or sex (or both)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Janssen R&D, LLC Titusville New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clean Cohort: Incidence Rate of Pigmentary Maculopathy (PM)/ Pigmentary Retinopathy (PR)/Any Cases Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to pentosan polysulfate sodium [PPS]). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk. Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Primary Clean Cohort: Incidence Rate of PM/PR/PPS Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to PPS). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk. Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Primary Clean Cohort: Incidence Rate of PM/PR/Non-PPS Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants not exposed to PPS). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk. Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Primary Clean Cohort: Prevalence Rate of PM/PR/Any Cases Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS). Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Primary Clean Cohort: Prevalence Rate of PM/PR/PPS Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS). Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Primary Clean Cohort: Prevalence Rate of PM/PR/Non-PPS Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants not exposed to PPS). Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Primary Overall Cohort: Incidence Rate of PM/PR/Any Cases Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to pentosan polysulfate sodium [PPS]). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk. Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Primary Overall Cohort: Prevalence Rate of PM/PR/Any Cases Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS). Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Primary Overall Cohort: Incidence Rate of PM/PR/PPS Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to pentosan polysulfate sodium [PPS]). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk. Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Primary Overall Cohort: Prevalence Rate of PM/PR/PPS Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS). Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Primary Overall Cohort: Number of PM/PR/PPS Cases Among the PM/PR/Any Cases Number of PM/PR/PPS cases among the PM/PR/any cases will be reported. Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Primary Clean Cohort: Change in Visual Acuity (VA) in Relation to PPS Dose Change in VA in relation to PPS dose will be reported. It will be assessed based on the following categories: a) No change (refers to less than [<] 1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) greater than or equal to (>=) 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement. Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Primary Clean Cohort: Change in VA in Relation to PM/PR/Any Cases Change in VA in relation to study endpoint (PM/PR/Any) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement. Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Primary Clean Cohort: Change in VA in Relation to PM/PR/PPS Change in VA in relation to study endpoint (PM/PR/PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement. Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Primary Clean Cohorts: Change in VA in Relation to PM/PR/Non-PPS Change in VA in relation to study endpoint (PM/PR/Non-PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement. Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Primary Overall Cohort: Change in Visual Acuity (VA) in Relation to PPS Dose Change in VA in relation to PPS dose will be reported. It will be assessed based on the following categories: a) No change (refers to less than [<] 1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) greater than or equal to (>=) 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement. Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Primary Overall Cohort: Change in VA in Relation to PM/PR/Any Cases Change in VA in relation to study endpoint (PM/PR/Any) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement. Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Primary Overall Cohort: Change in VA in Relation to PM/PR/PPS Change in VA in relation to study endpoint (PM/PR/PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement. Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Primary Overall Cohort: Change in VA in Relation to PM/PR/Non-PPS Change in VA in relation to study endpoint (PM/PR/Non-PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement. Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Primary Interstitial Cystitis (IC) Cohort: Incidence Rate of PM/PR/Any Cases Among the Participants with IC and No-Exposure to PPS Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants not exposed to PPS). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases per number of person-years time at risk. Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Primary IC Cohort: Change in VA in Relation to PM/PR/Any Cases Change in VA in relation to study endpoint (PM/PR/Any) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement. Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Primary IC Cohort: Change in VA Based on Age Change in VA based on age among participants exposed to PPS and without exposure to PPS will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement. Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Primary IC Cohort: Change in VA Based on Sex Change in VA based on sex among participants exposed to PPS and without exposure to PPS will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement. Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Primary IC Cohort: Change in VA Based on Time Between the First and Last VA Measurement in Matched Cohorts Change in VA based on time between the first and last VA measurement in matched cohorts among participants exposed to PPS and without exposure to PPS will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement. Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Secondary Demographic characteristics of Cohorts: Age Demographic characteristics of cohorts (age) will be reported. Baseline
Secondary Demographic characteristics of Cohorts: Sex Demographic characteristics of cohorts (sex) will be reported. Baseline
Secondary Demographic characteristics of Cohorts: Race Demographic characteristics of cohorts (race including Asian, black or African American, other, White or Caucasian) will be reported. Baseline
Secondary Demographic characteristics of Cohorts: Ethnicity Demographic characteristics of cohorts (ethnicity including Hispanic and non-Hispanic) will be reported. Baseline
Secondary Number of Participants with Comorbidities Number of participants with general comorbidities (diabetes, hypertension, hypercholesterolemia, vaginitis, urinary tract infection [UTI], detrusor instability, urge incontinence, and overactive bladder, autoimmune disease, Malignant tumor(s) of head and neck [plus documentation of radiation therapy] and Radiation cystitis) and ocular comorbidities (diabetic retinopathy, diabetic macular edema, optic neuropathy, glaucoma, glaucoma-related procedure, cataract [diagnosis], cataract [procedure]) will be reported. Baseline
Secondary Number of Participants who had Provider Characteristics Number of participants who had provider characteristics (treating provider specialty [retina specialist, non-retina specialist, general ophthalmologist, optometrist]; rural or non-rural location of index practice [rural/non-rural; United States Department of Agriculture Economic research service 2010 classification]) will be reported. Baseline
Secondary Overall Cohort: Distribution of International Classification of Diseases (ICD)-9/10 Codes ICD-9/10 codes are compared among the participants who are exposed to PPS will be reported. Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Secondary Participant's Journey to PPS Participant's journey to PPS is defined as the sequence of medications and other interventions the participant received before and after receiving PPS. Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
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