An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD

XenoPort

Status and phase: Completed; Phase 2

Conditions: Gastroesophageal Reflux

Treatments: Drug: XP19986 SR3, 20 mg QD; Drug: XP19986 SR3, 30 mg BID; Drug: Placebo; Drug: XP19986 SR3, 40 mg QD; Drug: XP19986 SR3, 60 mg QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT00557401

XP-B-057

Details and patient eligibility

About

To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with symptomatic GERD

Enrollment: 156 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History and documentation of GERD diagnosed by a gastroenterologist, with symptoms (heartburn and/or regurgitation) on ≥ 3 days during the week prior to screening and prior to randomization

Exclusion criteria

• Current or historical endoscopic evidence of erosive esophagitis LA Classification Grade B, C, or D

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

156 participants in 5 patient groups, including a placebo group

XP19986 SR3, 20 mg QD

Experimental group

Description:

XP19986, 20 mg QD for approximately 32 days

Treatment:

Drug: XP19986 SR3, 20 mg QD

XP19986 SR3, 40 mg QD

Experimental group

Description:

XP19986, 40 mg QD for approximately 32 days

Treatment:

Drug: XP19986 SR3, 40 mg QD

XP19986 SR3, 60 mg QD

Experimental group

Description:

XP19986, 60 mg QD for approximately 32 days

Treatment:

Drug: XP19986 SR3, 60 mg QD

XP19986 SR3, 30 mg BID

Experimental group

Description:

XP19986, 30 mg BID for approximately 32 days

Treatment:

Drug: XP19986 SR3, 30 mg BID

Placebo

Placebo Comparator group

Description:

Placebo for approximately 32 days

Treatment:

Drug: Placebo