Trial · NCT00086684
Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
NCT00086684, Phase 4, Terminated, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2012-07-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis. Trials, record NCT00086684. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00086684
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
- NCT number
- NCT00086684
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 369 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Interstitial Cystitis
- Interventions
- Pentosan polysulfate sodium 100 mg, Placebo, Pentosan polysulfate sodium 100 mg
- First posted
- 2004-07-09
- Last updated
- 2014-04-21
- Results first posted
- 2012-07-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Responders Defined as Having at Least a 30% Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint | Baseline to Week 24 | The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition. |
| Secondary | Number of Responders Defined as Having at Least a Four Point Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint | Baseline to Week 24 | The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Responders Defined as Having at Least a 30% Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint | Baseline to Week 24 | Intent-to-Treat (ITT) Analysis set | participants | NUMBER |
| SECONDARY | Number of Responders Defined as Having at Least a Four Point Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint | Baseline to Week 24 | Intent-to-Treat (ITT) Analysis set | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Responders Defined as Having at Least a 30% Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint | PLACEBO | 48 | participants | ||
| Number of Responders Defined as Having at Least a 30% Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint | Pentosan Polysulfate Sodium (ELMIRON) 100MG QD | 51 | participants | ||
| Number of Responders Defined as Having at Least a 30% Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint | Pentosan Polysulfate Sodium (ELMIRON) 100MG TID | 52 | participants | ||
| Number of Responders Defined as Having at Least a Four Point Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint | PLACEBO | 55 | participants | ||
| Number of Responders Defined as Having at Least a Four Point Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint | Pentosan Polysulfate Sodium (ELMIRON) 100MG QD | 55 | participants | ||
| Number of Responders Defined as Having at Least a Four Point Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint | Pentosan Polysulfate Sodium (ELMIRON) 100MG TID | 60 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PLACEBO | 118 | |
| Overall Study | STARTED | Pentosan Polysulfate Sodium (ELMIRON) 100MG QD | 129 | |
| Overall Study | STARTED | Pentosan Polysulfate Sodium (ELMIRON) 100MG TID | 122 | |
| Overall Study | COMPLETED | PLACEBO | 63 | |
| Overall Study | COMPLETED | Pentosan Polysulfate Sodium (ELMIRON) 100MG QD | 74 | |
| Overall Study | COMPLETED | Pentosan Polysulfate Sodium (ELMIRON) 100MG TID | 69 | |
| Overall Study | NOT COMPLETED | PLACEBO | 55 | |
| Overall Study | NOT COMPLETED | Pentosan Polysulfate Sodium (ELMIRON) 100MG QD | 55 | |
| Overall Study | NOT COMPLETED | Pentosan Polysulfate Sodium (ELMIRON) 100MG TID | 53 |
Source ClinicalTrials.gov
Adverse events621
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | PLACEBO | 0 | 118 | |
| other | Anaemia | Blood and lymphatic system disorders | Pentosan Polysulfate Sodium (ELMIRON) 100MG QD | 1 | 128 | |
| other | Anaemia | Blood and lymphatic system disorders | Pentosan Polysulfate Sodium (ELMIRON) 100MG TID | 0 | 122 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | PLACEBO | 1 | 118 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Pentosan Polysulfate Sodium (ELMIRON) 100MG QD | 1 | 128 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Pentosan Polysulfate Sodium (ELMIRON) 100MG TID | 1 | 122 | |
| other | Stargardt's Disease | Congenital, familial and genetic disorders | PLACEBO | 1 | 118 | |
| other | Stargardt's Disease | Congenital, familial and genetic disorders | Pentosan Polysulfate Sodium (ELMIRON) 100MG QD | 0 | 128 | |
| other | Stargardt's Disease | Congenital, familial and genetic disorders | Pentosan Polysulfate Sodium (ELMIRON) 100MG TID | 0 | 122 | |
| other | Deafness Unilateral | Ear and labyrinth disorders | PLACEBO | 0 | 118 |
1 to 10 of 621Source ClinicalTrials.gov
See all 621 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PLACEBO | ||
| Total, all-cause mortality | Pentosan Polysulfate Sodium (ELMIRON) 100MG QD | ||
| Total, all-cause mortality | Pentosan Polysulfate Sodium (ELMIRON) 100MG TID | ||
| Total, other adverse events | PLACEBO | 95 | 118 |
| Total, other adverse events | Pentosan Polysulfate Sodium (ELMIRON) 100MG QD | 107 | 128 |
| Total, other adverse events | Pentosan Polysulfate Sodium (ELMIRON) 100MG TID | 97 | 122 |
| Total, serious adverse events | PLACEBO | 4 | 118 |
| Total, serious adverse events | Pentosan Polysulfate Sodium (ELMIRON) 100MG QD | 4 | 128 |
| Total, serious adverse events | Pentosan Polysulfate Sodium (ELMIRON) 100MG TID | 0 | 122 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32734597 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00086684
GET https://conductscience.org/api/trials/v1/NCT00086684/events?page=2