Drug treatment of Laryngopharyngeal Reflux (LPR)

A randomised controlled trial of the efficacy of a Proton Pump Inhibitor (PPI) and / or alginate in the treatment of Laryngopharyngeal Reflux (LPR) in adult patients in secondary care

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN03482154

Enrollment

1500

Registered

2011-10-06

Start date

2013-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngopharyngeal reflux (LPR) Digestive System

Interventions

1. Patients will receive omeprazole 40 mg or placebo once daily (OD) and 2. Sodium alginate and potassium bicarbonate (Gaviscon® advance) or placebo 5 ml four times a day (QDS) for 6 months Updated

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All adult patients, aged 16 years and over referred from general practice to secondary care who following consultation with an Otolaryngological specialist have a working diagnosis for their symptoms of LPR

Exclusion criteria

Exclusion criteria: 1. Children 2. Known or likely upper aerodigestive tract malignancy 3. Pregnancy 4. Known or suspected allergies to any medications used in the trial

Design outcomes

Primary

Measure	Time frame
Improvement in validated symptom scores using standardised validated questionnaires. Time points of measurement 2, 4 and 6 months	—

Secondary

Measure	Time frame
1. Laryngeal examination improvement (validated scoring system) at 2 and 6 months in a subgroup of patients 2. Physiological studies (pH / impedance) testing in a subgroup at 2 and 6 months 3. Tissue biopsy pre-treatment and at 2 and /or 6 months	—

Countries

Belgium, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026