A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.

Start Date23 Oct 2008

Sponsor / Collaborator-

NCT00739739 / CompletedPhase 2

A Phase 2, 12 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Proof Of Concept Study Evaluating The Efficacy And Safety Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis/Painful Bladder Syndrome.

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.

Start Date01 Aug 2008

Sponsor / Collaborator

Pfizer Inc.

NCT00314964 / CompletedPhase 2

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study Evaluating PD-0299685 for Treatment of Vasomotor Symptoms Associated With Menopause

The primary purpose of this study is to determine if PD-0299685 is effective and safe in the treatment of vasomotor symptoms (hot flashes / flushes) associated with menopause.

Start Date01 Aug 2006

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with PD-0299685

100 Translational Medicine associated with PD-0299685

100 Patents (Medical) associated with PD-0299685

Literatures (Medical) associated with PD-0299685

03 May 2016·Expert Opinion on Investigational DrugsQ2 · MEDICINE

Investigational drugs for bladder pain syndrome (BPS) / interstitial cystitis (IC)

Q2 · MEDICINE

Review

Author: Kashyap, Mahendra ; Tyagi, Pradeep ; Chermansky, Christopher ; Chuang, Yao-Chi

INTRODUCTIONBladder pain syndrome (BPS)/interstitial cystitis (IC) is associated with sensory lower urinary tract symptoms. Unfortunately, many of the existing oral treatments are ineffective in most patients of BPS/IC, which is the motivation for developing new drugs and therapeutic approaches. This review covers the latest drugs that have been investigated in BPS/IC patients. Intravesical treatments offer the opportunity to directly target the painful bladder with less systemic side effects.AREAS COVEREDIn this review, the authors analyze the existing literature supporting the treatment of BPS/IC with conventional drugs including heparin, hyaluronic acid, chondroitin sulfate, and dimethylsulfoxide (DMSO). Furthermore, investigational drugs such as tanezumab and adalimumab, capable of sequestering nerve growth factor (NGF), and Tumor necrosis factor-α (TNF- α) are discussed. Investigational treatments such as liposomes, botulinum toxin (BTX), liposomal BTX, PD-0299685 (a Ca(2+) channel ɑ2δ ligand), continuous intravesical lidocaine, and AQX-1125 (a novel SHIP1 activating compound) are also covered.EXPERT OPINIONNew investigational drugs offer promising improvements in clinical outcomes for BPS/IC patients; however, BPS/IC is a chronic pain disorder that is very vulnerable to a strong placebo effect. In addition, BPS/IC is a heterogeneous disorder that can be classified into several phenotypes. Since different phenotypes of BPS/IC respond differently to systemic and intravesical treatments, the authors believe that new drugs developed for BPS/IC are more likely to meet their predetermined clinical endpoints if the inclusion/exclusion criterion is tailored to specific phenotype of BPS/IC patients.

01 Sep 2012·Journal of UrologyQ1 · MEDICINE

Investigation of a Ca ²⁺ Channel α2δ Ligand for the Treatment of Interstitial Cystitis: Results of a Randomized, Double-Blind, Placebo Controlled Phase II Trial

Q1 · MEDICINE

Article

Author: Crook, Tim ; Nickel, J. Curtis ; Haab, François ; Mills, Ian W. ; Scholfield, David ; Davis, Edward ; Rovner, Eric ; Crossland, Anna

PURPOSEWe investigated PD-0299685, a Ca(2+) channel α2δ ligand, for interstitial cystitis pain in a randomized, double-blind, placebo controlled phase IIa study.MATERIALS AND METHODSPatients with interstitial cystitis/bladder pain syndrome received 30 or 60 mg PD-0299685 daily or placebo for 12 weeks. Primary end points were change in average daily worst pain severity score (on an 11-point numerical rating scale) and change in Interstitial Cystitis Symptom Index score from baseline to week 12. Secondary end points included global response assessment, micturition and urgency episode frequency per 24 hours and mean voided volume per micturition. Incidence of adverse events was also assessed.RESULTSOf 161 patients 54 received 30 mg PD-0299685 daily, 55 received 60 mg PD-0299685 daily and 52 received placebo. At week 12 the 60 mg dose produced a clinically significant reduction in daily worst pain severity score from baseline compared to placebo (treatment difference [90% CI] -0.82 [-1.72, 0.08]). A greater proportion of patients taking 60 mg PD-0299685 daily demonstrated improvement in global response assessment. PD-0299685 had no clinically significant effect on the Interstitial Cystitis Symptom Index score or urinary end points. More patients discontinued due to treatment related adverse events with 30 or 60 mg PD-0299685 daily than with the placebo.CONCLUSIONSPD-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.

100 Deals associated with PD-0299685

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hot Flashes	Phase 2	ZA	Pfizer Inc.	01 Aug 2006
Hot Flashes	Phase 2	AU	Pfizer Inc.	01 Aug 2006
Hot Flashes	Phase 2	ES	Pfizer Inc.	01 Aug 2006
Hot Flashes	Phase 2	FR	Pfizer Inc.	01 Aug 2006
Vasomotor symptom	Phase 2	FR	Pfizer Inc.	01 Aug 2006
Vasomotor symptom	Phase 2	ES	Pfizer Inc.	01 Aug 2006
Vasomotor symptom	Phase 2	US	Pfizer Inc.	01 Aug 2006
Vasomotor symptom	Phase 2	CA	Pfizer Inc.	01 Aug 2006
Vasomotor symptom	Phase 2	ZA	Pfizer Inc.	01 Aug 2006
Vasomotor symptom	Phase 2	AU	Pfizer Inc.	01 Aug 2006

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