A Phase 2 Study to Evaluate Once Daily Low Dose and High Dose Solabegron or Placebo Given for 12 Weeks to Treat Women With Symptoms of Overactive Bladder: Sudden Urge to Urinate, Frequent Urination Associated With Wetting Episodes (VEL-2001)
Description
This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of solabegron modified release low dose or high dose tablets, compared to matched placebo, administered once daily for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency, and predominantly urgency incontinence) for at least 6 months.
Study Start Date
July, 09 2018
Estimated Completion Date
March 2019
Interventions
- Drug: Solabegron modified release tablets, high dose
- Drug: Matching Placebo
- Drug: Solabegron modified release tablets, low dose
Study ID
Velicept Therapeutics, Inc. -- VEL-2001
Status
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Error Details:
| struct | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Cause |
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| Detail | An exception occurred while invoking an event handler method from Application.cfc. The method name is: onRequest. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Message | Event handler exception. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RootCause |
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| StackTrace | coldfusion.runtime.EventHandlerException: Event handler exception. at coldfusion.runtime.AppEventInvoker.onRequest(AppEventInvoker.java:309) at coldfusion.filter.ApplicationFilter.invoke(ApplicationFilter.java:470) at coldfusion.filter.RequestMonitorFilter.invoke(RequestMonitorFilter.java:42) at coldfusion.filter.MonitoringFilter.invoke(MonitoringFilter.java:40) at coldfusion.filter.PathFilter.invoke(PathFilter.java:153) at coldfusion.filter.ExceptionFilter.invoke(ExceptionFilter.java:94) at coldfusion.filter.BrowserDebugFilter.invoke(BrowserDebugFilter.java:78) at coldfusion.filter.ClientScopePersistenceFilter.invoke(ClientScopePersistenceFilter.java:28) at coldfusion.filter.BrowserFilter.invoke(BrowserFilter.java:38) at coldfusion.filter.NoCacheFilter.invoke(NoCacheFilter.java:58) at coldfusion.filter.GlobalsFilter.invoke(GlobalsFilter.java:38) at coldfusion.filter.DatasourceFilter.invoke(DatasourceFilter.java:22) at coldfusion.filter.CachingFilter.invoke(CachingFilter.java:62) at coldfusion.CfmServlet.service(CfmServlet.java:219) at coldfusion.bootstrap.BootstrapServlet.service(BootstrapServlet.java:89) at org.apache.catalina.core.ApplicationFilterChain.internalDoFilter(ApplicationFilterChain.java:303) at org.apache.catalina.core.ApplicationFilterChain.doFilter(ApplicationFilterChain.java:208) at coldfusion.monitor.event.MonitoringServletFilter.doFilter(MonitoringServletFilter.java:42) at coldfusion.bootstrap.BootstrapFilter.doFilter(BootstrapFilter.java:46) at org.apache.catalina.core.ApplicationFilterChain.internalDoFilter(ApplicationFilterChain.java:241) at org.apache.catalina.core.ApplicationFilterChain.doFilter(ApplicationFilterChain.java:208) at coldfusion.inspect.weinre.MobileDeviceDomInspectionFilter.doFilter(MobileDeviceDomInspectionFilter.java:57) at coldfusion.bootstrap.BootstrapFilter.doFilter(BootstrapFilter.java:46) at org.apache.catalina.core.ApplicationFilterChain.internalDoFilter(ApplicationFilterChain.java:241) at org.apache.catalina.core.ApplicationFilterChain.doFilter(ApplicationFilterChain.java:208) at org.apache.catalina.core.StandardWrapperValve.invoke(StandardWrapperValve.java:219) at org.apache.catalina.core.StandardContextValve.invoke(StandardContextValve.java:110) at org.apache.catalina.authenticator.AuthenticatorBase.invoke(AuthenticatorBase.java:494) at org.apache.catalina.core.StandardHostValve.invoke(StandardHostValve.java:169) at org.apache.catalina.valves.ErrorReportValve.invoke(ErrorReportValve.java:104) at org.apache.catalina.core.StandardEngineValve.invoke(StandardEngineValve.java:116) at org.apache.catalina.connector.CoyoteAdapter.service(CoyoteAdapter.java:458) at org.apache.coyote.ajp.AjpProcessor.process(AjpProcessor.java:196) at org.apache.coyote.AbstractProtocol$AbstractConnectionHandler.process(AbstractProtocol.java:637) at org.apache.tomcat.util.net.JIoEndpoint$SocketProcessor.run(JIoEndpoint.java:316) at java.util.concurrent.ThreadPoolExecutor.runWorker(Unknown Source) at java.util.concurrent.ThreadPoolExecutor$Worker.run(Unknown Source) at org.apache.tomcat.util.threads.TaskThread$WrappingRunnable.run(TaskThread.java:61) at java.lang.Thread.run(Unknown Source) Caused by: coldfusion.runtime.CFPage$InvalidDateException: Date value passed to date function DateDiff is unspecified or invalid. at coldfusion.runtime.CFPage.DateDiff(CFPage.java:1604) at cftrial2ddetails2ecfm1310202973.runPage(C:\inetpub\wwwroot\trial-details.cfm:187) at coldfusion.runtime.CfJspPage.invoke(CfJspPage.java:247) at coldfusion.tagext.lang.IncludeTag.handlePageInvoke(IncludeTag.java:736) at coldfusion.tagext.lang.IncludeTag.doStartTag(IncludeTag.java:572) at coldfusion.runtime.CfJspPage._emptyTcfTag(CfJspPage.java:3011) at cfindex2ecfm944125949._factor8(C:\inetpub\wwwroot\index.cfm:302) at cfindex2ecfm944125949.runPage(C:\inetpub\wwwroot\index.cfm:1) at coldfusion.runtime.CfJspPage.invoke(CfJspPage.java:247) at coldfusion.tagext.lang.IncludeTag.handlePageInvoke(IncludeTag.java:736) at coldfusion.tagext.lang.IncludeTag.doStartTag(IncludeTag.java:572) at coldfusion.runtime.CfJspPage._emptyTcfTag(CfJspPage.java:3011) at cfApplication2ecfc953308886$funcONREQUEST.runFunction(C:\inetpub\wwwroot\Application.cfc:147) at coldfusion.runtime.UDFMethod.invoke(UDFMethod.java:487) at coldfusion.runtime.UDFMethod$ReturnTypeFilter.invoke(UDFMethod.java:420) at coldfusion.runtime.UDFMethod$ArgumentCollectionFilter.invoke(UDFMethod.java:383) at coldfusion.filter.FunctionAccessFilter.invoke(FunctionAccessFilter.java:95) at coldfusion.runtime.UDFMethod.runFilterChain(UDFMethod.java:334) at coldfusion.runtime.UDFMethod.invoke(UDFMethod.java:231) at coldfusion.runtime.TemplateProxy.invoke(TemplateProxy.java:646) at coldfusion.runtime.TemplateProxy.invoke(TemplateProxy.java:435) at coldfusion.runtime.TemplateProxy.invoke(TemplateProxy.java:405) at coldfusion.runtime.AppEventInvoker.invoke(AppEventInvoker.java:108) at coldfusion.runtime.AppEventInvoker.onRequest(AppEventInvoker.java:301) ... 38 more | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Suppressed |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| TagContext |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Type | Expression | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| name | onRequest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Session:
| struct | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| authorized | no | ||||||||||||
| cfid | 8667291 | ||||||||||||
| cftoken | 614054429f32c4cf-BA497187-5056-B902-141D2DA8877F7B23 | ||||||||||||
| confirm_token | 0 | ||||||||||||
| confirmed_ind | 0 | ||||||||||||
| country | [empty string] | ||||||||||||
| [empty string] | |||||||||||||
| fname | [empty string] | ||||||||||||
| last_login | [empty string] | ||||||||||||
| lname | [empty string] | ||||||||||||
| locstruct |
|
||||||||||||
| opt_in_ind | 0 | ||||||||||||
| profession | [empty string] | ||||||||||||
| professiontblvar | REF_PROFESSION | ||||||||||||
| refspecialtytblvar | REF_SPECIALTY | ||||||||||||
| refspectblvar | REF_SPEC | ||||||||||||
| sessionid | CLINICALTRIALSLOCATOR_PROD_8667291_614054429f32c4cf-BA497187-5056-B902-141D2DA8877F7B23 | ||||||||||||
| spec_id | [empty string] | ||||||||||||
| sponsored_modal | 0 | ||||||||||||
| state_cd | [empty string] | ||||||||||||
| u_spec | [empty string] | ||||||||||||
| urltoken | CFID=8667291&CFTOKEN=614054429f32c4cf-BA497187-5056-B902-141D2DA8877F7B23 | ||||||||||||
| user_id | [empty string] | ||||||||||||
| user_type | [empty string] | ||||||||||||
| zip | [empty string] | ||||||||||||
Form:
| struct [empty] |
|---|
CGI:
| struct | |
|---|---|
| AUTH_PASSWORD | [empty string] |
| AUTH_TYPE | [empty string] |
| AUTH_USER | [empty string] |
| CERT_COOKIE | [empty string] |
| CERT_FLAGS | [empty string] |
| CERT_ISSUER | [empty string] |
| CERT_KEYSIZE | 256 |
| CERT_SECRETKEYSIZE | 4096 |
| CERT_SERIALNUMBER | [empty string] |
| CERT_SERVER_ISSUER | C=US, S=Arizona, L=Scottsdale, O="GoDaddy.com, Inc.", OU=http://certs.godaddy.com/repository/, CN=Go Daddy Secure Certificate Authority - G2 |
| CERT_SERVER_SUBJECT | OU=Domain Control Validated, CN=*.clinicaltrialslocator.com |
| CERT_SUBJECT | [empty string] |
| CF_TEMPLATE_PATH | C:\inetpub\wwwroot\index.cfm |
| CONTENT_LENGTH | 0 |
| CONTENT_TYPE | [empty string] |
| CONTEXT_PATH | [empty string] |
| GATEWAY_INTERFACE | CGI/1.1 |
| HTTPS | on |
| HTTPS_KEYSIZE | 256 |
| HTTPS_SECRETKEYSIZE | 4096 |
| HTTPS_SERVER_ISSUER | C=US, S=Arizona, L=Scottsdale, O="GoDaddy.com, Inc.", OU=http://certs.godaddy.com/repository/, CN=Go Daddy Secure Certificate Authority - G2 |
| HTTPS_SERVER_SUBJECT | OU=Domain Control Validated, CN=*.clinicaltrialslocator.com |
| HTTP_ACCEPT | text/html,application/xhtml+xml,application/xml;q=0.9,*/*;q=0.8 |
| HTTP_ACCEPT_ENCODING | br,gzip |
| HTTP_ACCEPT_LANGUAGE | en-US,en;q=0.5 |
| HTTP_CONNECTION | Keep-Alive |
| HTTP_COOKIE | [empty string] |
| HTTP_HOST | clinicaltrialslocator.com |
| HTTP_REFERER | [empty string] |
| HTTP_URL | [empty string] |
| HTTP_USER_AGENT | CCBot/2.0 (https://commoncrawl.org/faq/) |
| LOCAL_ADDR | www.clinicaltrialslocator.com |
| PATH_INFO | /index.cfm |
| PATH_TRANSLATED | C:\inetpub\wwwroot\index.cfm |
| QUERY_STRING | pg=trial-details&nct_id=NCT03594058&srch_radius=0&srch_zip=06828&srch_phase=&alpha_filter=A&actively_recruiting=Y&srch_condition= |
| REMOTE_ADDR | 35.172.233.2 |
| REMOTE_HOST | 35.172.233.2 |
| REMOTE_USER | [empty string] |
| REQUEST_METHOD | GET |
| SCRIPT_NAME | /index.cfm |
| SERVER_NAME | clinicaltrialslocator.com |
| SERVER_PORT | 443 |
| SERVER_PORT_SECURE | 1 |
| SERVER_PROTOCOL | HTTP/1.1 |
| SERVER_SOFTWARE | Microsoft-IIS/8.5 |
| WEB_SERVER_API | [empty string] |
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