A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain
Description
The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).
Study Start Date
May, 23 2019
Estimated Completion Date
July 2022
Interventions
- Drug: Placebo linzagolix and linzagolix tablets and Placebo Add-back capsule
- Drug: Placebo linzagolix tablets and Placebo Add-back capsule
- Drug: Placebo linzagolix and linzagolix tablets and Add-back capsule
Study ID
ObsEva SA -- 18-OBE2109-002
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 | 14921021 | ||||||||||||
| cftoken | dcfc6d1915df2b6f-3160B75E-5056-B902-14D1BECF900E57FF | ||||||||||||
| 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_14921021_dcfc6d1915df2b6f-3160B75E-5056-B902-14D1BECF900E57FF | ||||||||||||
| spec_id | [empty string] | ||||||||||||
| sponsored_modal | 0 | ||||||||||||
| state_cd | [empty string] | ||||||||||||
| u_spec | [empty string] | ||||||||||||
| urltoken | CFID=14921021&CFTOKEN=dcfc6d1915df2b6f-3160B75E-5056-B902-14D1BECF900E57FF | ||||||||||||
| 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 | clinicaltrialslocator.com |
| PATH_INFO | /index.cfm |
| PATH_TRANSLATED | C:\inetpub\wwwroot\index.cfm |
| QUERY_STRING | pg=trial-details&nct_id=NCT03986944&srch_radius=0&srch_zip=06828&srch_phase=&alpha_filter=A&actively_recruiting=Y&srch_condition= |
| REMOTE_ADDR | 18.206.177.17 |
| REMOTE_HOST | 18.206.177.17 |
| 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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