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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00618150
Other study ID # Sak 33-96 (REK)
Secondary ID SLKNR 96/00515
Status Completed
Phase N/A
First received February 5, 2008
Last updated January 16, 2017
Start date September 1996

Study information

Verified date January 2017
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with gastroesophageal reflux disease (heart-burn, acid regurgitation)may benefit from an educational program explaining the medical aspects of the disease, self-management strategies and how to deal with health services. We hypothesized that patients having participated in an educational program would experience an improved quality of life when compared to patients who did not take part (controls).


Recruitment information / eligibility

Status Completed
Enrollment 211
Est. completion date
Est. primary completion date December 1999
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- heartburn and acid regurgitation the dominant symptom

- needing relief at least 5 days/ week when symptoms were at their worst

- disease history at least 3 months

- ability to give informed consent

Exclusion Criteria:

- current or previous esophagitis stage 2(Savary-Miller) or greater or peptic ulc

- continuous need of proton pump inhibitors or NSAIDs

- wish for surgical treatment

- earlier surgical treatment in the GI-tract

- pregnancy

- alcohol or drug abuse

Study Design


Intervention

Behavioral:
Patient education
An educational program: Three lessons spaced over 2 weeks.

Locations

Country Name City State
Norway Norwegian University of Science and Technology, Med. fac. Trondheim

Sponsors (2)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Norwegian Foundation for Health and Rehabilitation

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Urnes J, Farup PG, Lydersen S, Petersen H. Patient education in gastro-oesophageal reflux disease: a randomized controlled trial. Eur J Gastroenterol Hepatol. 2007 Dec;19(12):1104-10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life one year
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