Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux Esophagitis

Refractory Reflux Esophagitis Clinical Trial

Official title:

Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux Esophagitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321567
• Other study ID #: PRT11T
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: August 1, 2013

Study information

• Verified date: May 2015
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with Proton Pump Inhibitor-resistant reflux esophagitis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2157
• Est. completion date: August 1, 2013
• Est. primary completion date: March 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria;

-Proton pump inhibitor-resistant reflux esophagitis. (Patients who have mucosal breaks (erosions, ulcers) on endoscopy)

Exclusion criteria;

• Patients with a history of hypersensitivity to any ingredients of PARIET.

• Patients on atazanavir sulfate.

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Gastroesophageal Reflux
• Refractory Reflux Esophagitis

Intervention

Drug:
• rabeprazole sodium
Doses of 10 mg or 20 mg twice daily may be administered orally to reflux esophagitis patients for a further 8 weeks when proton pump inhibitor treatment is ineffective. However, a dose of 20 mg twice daily should only be administered to patients with severe mucosa injury.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Kinoshita Y, Hongo M, Kusano M, Furuhata Y, Miyagishi H, Ikeuchi S; RPZ Study Group. Therapeutic Response to Twice-daily Rabeprazole on Health-related Quality of Life and Symptoms in Patients with Refractory Reflux Esophagitis: A Multicenter Observational — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with improvement based on health related Quality of Life (QOL) questionnaire		Check at predose, 4, 8, 16 and 32 weeks
Secondary	Number of subjects with improvement in symptoms of GERD		Check at predose, 4, 8, 16 and 32 weeks
Secondary	Endoscopic healing rate		8 weeks
Secondary	Adverse events		Every 4-8 weeks