drugset / Trial / NCT00739739
An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to determine whether PD 0299685 is effective in the treatment of symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain, urinary urgency and frequency. At the same time assess the drug's safety and tolerability.
Timeline
- Start
- 2008-08
- Primary completion
- 2010-01
- Completion
- 2010-01
Outcome
Missed primary endpoint
paper PD-0299685 had no clinically significant effect on the Interstitial Cystitis Symptom Index score or urinary end points. PMID 22818144 ↗
paper PD-0299685 failed to demonstrate positive proof of concept for the treatment of pain and other urinary end points associated with interstitial cystitis/bladder pain syndrome. PMID 22818144 ↗
Publications
- Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
- Nickel JC, Crossland A, Davis E, Haab F, Mills IW, Rovner E, Scholfield D, Crook T. Investigation of a Ca2+ channel alpha2delta ligand for the treatment of interstitial cystitis: results of a randomized, double-blind, placebo controlled phase II trial. J Urol. 2012 Sep;188(3):817-23. doi: 10.1016/j.juro.2012.05.010. Epub 2012 Jul 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PD 0299685 | Small molecule | 15 mg | — |
| Subject | PD 0299685 | Small molecule | 30 mg | — |