NCT01130935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
491

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Shorter than P25 for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

Enrollment Period

6 months

First QC Date

May 20, 2010

Last Update Submit

February 23, 2011

Conditions

Gastric Acid SuppressionProton Pump Inhibitors

Keywords

GERDgastric and duodenal ulcersNSAID therapy

Outcome Measures

Primary Outcomes (3)

  • Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.

    Day 0

  • Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.

    Week 2-4

  • Frequency and severity of upper GI symptoms and the overall patient's discomfort during the last week.

    Weeks 8-12

Secondary Outcomes (7)

  • To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.

    Day 0

  • 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

  • Evaluate the tolerability of Nexium in patients with upper GI symptoms by the number of participants with adverse events.

    Day 0

  • To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.

    Weeks 2-4

  • To follow the frequency, type and severity of symptoms in subjects consulting the doctors with upper GI symptoms.

    Weeks 8-12

  • +2 more secondary outcomes

Study Arms (1)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Male or female subjects, age \> 18 years, having had upper GI symptoms requiring acid suppression treatment.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Research Site

Berat, Albania

Location

Research Site

Burrel, Albania

Location

Research Site

Durrës, Albania

Location

Research Site

Elbasan, Albania

Location

Research Site

Fier, Albania

Location

Research Site

Kavajë, Albania

Location

Research Site

Korçë, Albania

Location

Research Site

Krujë, Albania

Location

Research Site

Lezhë, Albania

Location

Research Site

Lushnjë, Albania

Location

Research Site

Peshkopi, Albania

Location

Research Site

Shkodër, Albania

Location

Research Site

Tirana, Albania

Location

Research Site

Vlorë, Albania

Location

MeSH Terms

Conditions

Gastroesophageal RefluxDuodenal Ulcer

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPeptic UlcerDuodenal DiseasesIntestinal DiseasesStomach Diseases

Study Officials

  • Karin Otter, MD, PhD

    Medical Director BBC

    STUDY DIRECTOR

  • Senka Riza

    Medical and Regulatory Manager

    STUDY CHAIR

  • Skerdi Prifti, Asc.Proff.

    University Hospital Center "Mother Teresa"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 20, 2010

First Posted

May 26, 2010

Study Start

May 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

February 24, 2011

Record last verified: 2011-02

Locations

AL(14)