Non-interventional Study to Evaluate the Change in Symptoms Scores and Treatment Response After 4 Weeks of Proton-Pump Inhibitors (PPI) Treatment

Gastroesophageal Reflux Clinical Trial

Official title:

A Prospective, Non-interventional Study to Evaluate the Change in Symptoms Scores and Treatment Response After 4 Weeks of Systematic Treatment With PPIs in GERD Patients in Primary Care Setting in Romania, Using the Validated GerdQ Questionnaire.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103804
• Other study ID #: NIS-GRO-DUM-2009/1
• Status: Completed
• Phase: N/A
• First received: April 13, 2010
• Last updated: January 10, 2011
• Start date: March 2010
• Est. completion date: September 2010

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines Agency
• Study type: Observational

Clinical Trial Summary

The primary objective of the study is to describe the change in GerdQ sum scores, after a 4-week period of systematic treatment with PPIs(using GerdQ questionnaire). The secondary objectives are: to measure the response at the current treatment after a 4-week period of systematic treatment and to identify the percentage of patients which require alterations of their treatment (GerdQ questionnaire)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 952
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provision of informed consent

• Patients known or newly diagnosed with GERD or patients with typical symptoms of GERD- heartburn, regurgitation (in the last case, GerdQ sum score should be =8, in the absence of PPI treatment)

Exclusion Criteria:

• Any symptoms at visit 1 suggesting a need for further investigation, judged by the Investigator (alarm symptoms).The alarm symptoms suggesting complicated disease are: dysphagia, odynophagia, bleeding, weight loss without intention or anemia.

• Previous participation in the present study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Locations

Country	Name	City	State
Romania	Research Site	Arad
Romania	Research Site	Bacau
Romania	Research Site	Braila
Romania	Research Site	Brasov
Romania	Research Site	Bucharest
Romania	Research Site	Buzau
Romania	Research Site	Cluj
Romania	Research Site	Floresti
Romania	Research Site	Galati
Romania	Research Site	Iasi
Romania	Research Site	Pitesti
Romania	Research Site	Ploiesti
Romania	Research Site	Rm. Valcea
Romania	Research Site	Sibiu
Romania	Research Site	Slatina
Romania	Research Site	Targoviste
Romania	Research Site	Tg. Mures
Romania	Research Site	Timisoara
Romania	Research Site	Vanatori(GL)

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	describe the change in GerdQ sum scores, after a 4-week period of systematic treatment with PPIs(GerdQ)		4 weeks(at V1 and V2)	No
Secondary	measure the response at the current treatment after a 4-week period of systematic treatment with PPIs(GerdQ)		4 weeks(at V1 and V2)	No
Secondary	identify the percentage of patients which require alterations of their treatment after a 4-week period of systematic treatment with PPIs(GerdQ)		4 weeks(at V1 and V2)	No