Condition category
Digestive System
Date applied
07/09/2010
Date assigned
08/09/2010
Last edited
21/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Kenneth E.L. McColl

ORCID ID

Contact details

Institute of Cardiovascular and Medical Sciences
44 Church Street
Glasgow
G11 6NT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy of lansoprazole versus placebo in treatment of dyspepsia symptoms in endoscopy negative patients: a randomised controlled clinical trial

Acronym

Study hypothesis

Proton pump inhibitor therapy is superior to placebo in treatment of symptoms of dyspeptic patients with normal endoscopy and negative for H. pylori.

Ethics approval

Greater Glasgow Health Board - The West Ethical Committee on 17/061997 (ref: 97/106(2) (AHT/JR))

Study design

Interventional double-blind randomised placebo controlled single centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Dyspepsia, upper gastrointestinal tract disease

Intervention

Active: Lansoprazole 30 mg per day, once per day, per oral, for 14 days. Follow up for 14 days.
Control: Placebo, once per day, per oral, for 14 days. Follow up for 14 days.

Intervention type

Drug

Phase

Not Applicable

Drug names

Lansoprazole

Primary outcome measures

Change in overall symptom score measured by modified Glasgow Dyspepsia Severity Score. All these measurements will be taken on baseline and at the end of 2 weeks.

Secondary outcome measures

Predictors of response to lansoprazole including symptom severity score, symptom characteristics, oesophageal 24h pH metry and oesophageal manometry profiles and body mass index (BMI). All these measurements will be taken on baseline.

Overall trial start date

01/12/1997

Overall trial end date

30/01/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Upper gastrointestinal (GI) symptoms of more than 3 months duration
2. No evidence of peptic ulcer disease, erosive oesophagitis or hiatus hernia in endoscopy
3. H. pylori negative on histology and urease test
4. Aged 24 - 72 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

105

Participant exclusion criteria

1. Current use of non-steroidal anti-inflammatory drugs or other medication
2. Any recognised cause of upper GI symptoms

Recruitment start date

01/12/1997

Recruitment end date

30/01/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Cardiovascular and Medical Sciences
Glasgow
G11 6NT
United Kingdom

Sponsor information

Organisation

University of Glasgow (UK)

Sponsor details

University Avenue
Glasgow
G12 8QQ
United Kingdom

Sponsor type

University/education

Website

http://www.gla.ac.uk/

Funders

Funder type

Industry

Funder name

Wyeth Laboratories (UK) (ref: PV 214058)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Western Infirmary (UK) - Hospital Endowment Fund (ref: 1116/6)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21159892

Publication citations

  1. Results

    Fletcher J, Derakhshan MH, Jones GR, Wirz AA, McColl KE, BMI is superior to symptoms in predicting response to proton pump inhibitor: randomised trial in patients with upper gastrointestinal symptoms and normal endoscopy., Gut, 2011, 60, 4, 442-448, doi: 10.1136/gut.2010.228064.

Additional files

Editorial Notes