TerminatedPhase 2

Efficacy And Safety Of PF-00885706 For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD)

Stopped: This study has been placed on clinical hold by the sponsor due to operational reasons.

Belgium, Brazil81 participantsStarted 2008-01

Plain-language summary

To understand the dose-response characteristics of PF-00885706 for efficacy in terms of symptomatic relief when used as add-on treatment to esomeprazole 20mg (standard proton pump inhibitor \[PPI\] treatment), in subjects with gastro-esophageal reflux (GERD) who have inadequate relief with PPIs.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects with a diagnosis of GERD who fulfill the following criteria: who have symptoms for least six months prior to enrollment; who are currently on daily treatment with a PPI and have been on such treatment for at least 3 months; whose symptoms are persistent, troublesome and that include heartburn and/or regurgitation as their predominant symptoms despite treatment with a PPI; who are seeking relief of persistent symptoms. Exclusion Criteria: * Subjects with erosive esophagitis - An endoscopy within the last 5 years is required to verify absence. * Subjects with any esophageal or gastric diseases/conditions that may contribute to their GERD symptoms. * If female; pregnant, lactating or positive serum or urine pregnancy tests.

What they're measuring

Complete resolution of heartburn and regurgitation. [i.e. no more than one day with either mild heartburn or regurgitation over the seven days prior to the assessment time-point (Visit 6 and Visit 8)]

Timeframe: 28 days

Trial details

NCT IDNCT00730665

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-10

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