Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01130935
First received: May 20, 2010
Last updated: February 23, 2011
Last verified: February 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Gastric Acid Suppression Proton Pump Inhibitors |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A National, Multicentre, Open-label, Non-comparative, Non-interventional Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking Nexium |
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
- Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. [ Time Frame: Week 2-4 ] [ Designated as safety issue: No ]
- Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week. [ Time Frame: Weeks 8-12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
- Evaluate with which treatment regimen and on which indications acid suppression with isomeric proton pump inhibitor is used in routine clinical practice in Albania. [ Time Frame: Once: Day 0 ] [ Designated as safety issue: No ]
- Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events. [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]
- To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. [ Time Frame: Weeks 2-4 ] [ Designated as safety issue: No ]
- To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms. [ Time Frame: Weeks 8-12 ] [ Designated as safety issue: No ]
- Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events. [ Time Frame: Weeks 2-4 ] [ Designated as safety issue: No ]
- Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events. [ Time Frame: Weeks 8-12 ] [ Designated as safety issue: No ]
| Enrollment: | 491 |
| Study Start Date: | May 2010 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Male or female subjects, age > 18 years, having had upper GI symptoms requiring acid suppression treatment.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130935
Locations
| 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, Albania | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Karin Otter, MD, PhD | Medical Director BBC |
| Study Chair: | Senka Riza | Medical and Regulatory Manager |
| Principal Investigator: | Skerdi Prifti, Asc.Proff. | University Hospital Center "Mother Teresa" |
More Information
No publications provided
| Responsible Party: | MC MD, AstraZeneca Albania |
| ClinicalTrials.gov Identifier: | NCT01130935 History of Changes |
| Other Study ID Numbers: | NIS-GAL-NEX-2010/1 |
| Study First Received: | May 20, 2010 |
| Last Updated: | February 23, 2011 |
| Health Authority: | Albania: Ministry of Health Department of Pharmacy |
Keywords provided by AstraZeneca:
|
GERD gastric and duodenal ulcers NSAID therapy |
ClinicalTrials.gov processed this record on May 23, 2013