Clinical trial NCT01130935: Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium
Official title: A National, Multicentre, Open-label, Non-comparative, Non-interventional Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Acid Suppression
Proton Pump Inhibitors
Keywords: GERD
gastric and duodenal ulcers
NSAID therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 491
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or female subjects, age \> 18 years, having had upper GI symptoms requiring acid suppression treatment.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.
timeFrame: Day 0
measure: Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.
timeFrame: Week 2-4
measure: Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.
timeFrame: Weeks 8-12
Secondary outcomes:
measure: To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.
timeFrame: Day 0
measure: Evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania.
timeFrame: Once: Day 0
measure: Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.
timeFrame: Day 0
measure: To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.
timeFrame: Weeks 2-4
measure: To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.
timeFrame: Weeks 8-12
measure: Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.
timeFrame: Weeks 2-4
measure: Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.
timeFrame: Weeks 8-12
Other outcomes:
Locations:
city: Berat
country: Albania
facility: Research Site
city: Burrel
country: Albania
facility: Research Site
city: Durres
country: Albania
facility: Research Site
city: Elbasan
country: Albania
facility: Research Site
city: Fier
country: Albania
facility: Research Site
city: Kavaje
country: Albania
facility: Research Site
city: Korce
country: Albania
facility: Research Site
city: Kruje
country: Albania
facility: Research Site
city: Lezhe
country: Albania
facility: Research Site
city: Lushnje
country: Albania
facility: Research Site
city: Peshkopi
country: Albania
facility: Research Site
city: Shkoder
country: Albania
facility: Research Site
city: Tirane
country: Albania
facility: Research Site
city: Vlore
country: Albania
facility: Research Site
Study officials:
affiliation: Medical Director BBC
name: Karin Otter, MD, PhD
role: STUDY_DIRECTOR
affiliation: Medical and Regulatory Manager
name: Senka Riza
role: STUDY_CHAIR
affiliation: University Hospital Center "Mother Teresa"
name: Skerdi Prifti, Asc.Proff.
role: PRINCIPAL_INVESTIGATOR
References: