Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium

Proton Pump Inhibitors Clinical Trial

Official title:

A National, Multicentre, Open-label, Non-comparative, Non-interventional Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130935
• Other study ID #: NIS-GAL-NEX-2010/1
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: February 23, 2011
• Start date: May 2010
• Est. completion date: November 2010

Study information

• Verified date: February 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Albania: Ministry of Health Department of Pharmacy
• Study type: Observational

Clinical Trial Summary

This study will assess the effectiveness of Nexium at alleviating upper GI symptoms in subjects and evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 491
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject must have had upper GI symptoms requiring acid suppression treatment

• Treatment with Nexium is in accordance with indications and dosing approved in Albania.

• Start of treatment at least 2 weeks prior to enrollment to this study 5. Written informed consent is signed.

Exclusion Criteria:

• Known hypersensitivity to Nexium or any other constituents of the formulation

• Concomitant administration of atazanavir and nelfinavir.

• Alarming upper GI symptoms (i.e. significant unintended weight loss, vomiting, dysphasia, hematemesis, melena, fever, jaundice or any other sign indicating serious or malignant disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Acid Suppression
• Proton Pump Inhibitors

Locations

Country	Name	City	State
Albania	Research Site	Berat
Albania	Research Site	Burrel
Albania	Research Site	Durres
Albania	Research Site	Elbasan
Albania	Research Site	Fier
Albania	Research Site	Kavaje
Albania	Research Site	Korce
Albania	Research Site	Kruje
Albania	Research Site	Lezhe
Albania	Research Site	Lushnje
Albania	Research Site	Peshkopi
Albania	Research Site	Shkoder
Albania	Research Site	Tirane
Albania	Research Site	Vlore

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Albania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.		Day 0	No
Primary	Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.		Week 2-4	No
Primary	Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.		Weeks 8-12	No
Secondary	To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.		Day 0	No
Secondary	Evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania.		Once: Day 0	No
Secondary	Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.		Day 0	Yes
Secondary	To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.		Weeks 2-4	No
Secondary	To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.		Weeks 8-12	No
Secondary	Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.		Weeks 2-4	No
Secondary	Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.		Weeks 8-12	No