Table 1

Objectives and outcome measures

ObjectivesOutcome measures
PrimaryTo compare the symptomatic response in patients with persistent throat symptoms (PTS) at the end of 8 weeks of treatment with liquid alginate (Gaviscon Advance) versus placebo
  • Total Reflux Symptom Index (RSI) at 8 weeks

SecondaryTo compare the symptomatic response in patients with PTS at the end of 8 weeks of treatment with a liquid alginate (Gaviscon Advance) versus placebo
  • RSI omitting the heartburn item at 8 weeks

  • Comprehensive Reflux Symptom Score and its oesophageal, upper airway and pharyngeal subscales at 8 weeks

To compare the symptomatic response in patients with PTS at 2, 4 and 6 weeks of treatment.
  • Total RSI at 2, 4 and 6 weeks

  • RSI omitting the heartburn item at 2, 4 and 6 weeks

To assess investigational medicinal product compliance at the end of 8 weeks of therapy
  • Participant reported trial medication compliance at 8 weeks

Participants’ view on which medication they received
  • Direct question of the participants opinion of whether they were taking Gaviscon Advance or placebo as part of the trial, asked at 8 weeks

Satisfaction with the trial
  • Overall Satisfaction Score Questionnaire at 8 weeks

  • Direct question of whether the participant would recommend the trial to family or friends, asked at 8 weeks