Autopsy report · NCT00086684

Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis

“Interim Analysis showed that study continuation was futile. No safety concerns were raised during the trial.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 10 months after it had already started.
• Ran for about 7 years 9 months before it stopped.
• 369 participants enrolled.
• Results were posted on the registry 1 year 1 month after it ended.

Vital statistics

Status

Terminated

Phase

Phase 4

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Sponsor type

Industry

Conditions

Interstitial Cystitis

Interventions

Pentosan polysulfate sodium 100 mg; Placebo; Pentosan polysulfate sodium 100 mg

Participants

369

Sites

65

Countries

Canada, United States

Trials that died the same way

• Adherence to Antidepressant Treatment in Subjects With Depression
  “The study was terminated early based on the planned interim analysis that did not meet criteria for continuation.” (77% match in meaning)
• Pemetrexed in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer
  “The results from the interim analysis were not favorable to continue this trial.” (76% match in meaning)
• Hiatal Interrogation in Sleeve Gastrectomy
  “interim analysis of the data was not supportive of continuing the study.” (73% match in meaning)
• An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
  “The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study” (73% match in meaning)
• Moxonidine in Patients Undergoing Vascular Surgery
  “Study was stopped after pre-definied interim analysis because of no effects” (72% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.