Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease

Samsung Medical Center

Status and phase: Unknown; Phase 3

Conditions: Laryngopharyngeal Reflux Disease

Treatments: Drug: Placebo; Drug: Motilitone; Drug: Pantoprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02533349

2015-05-007-001

Details and patient eligibility

About

Based on meta-analysis of prokinetics trials in laryngopharyngeal reflux disease (LPRD) (Glicksman et al. 2014), well designed study was performed in 4 articles. But, those studies had several problems including inclusion criteria, randomization methods, and placebo medication. They had similar results that prokinetics and proton pump inhibitor (PPI) had synergistic effect for management of LPRD. Therefore, the aim of study is to evaluate the efficacy of prokinetics as an additional medication to proton pump inhibitor by well designed randomized double blind case-control study.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age between 20 and 65 years
• Reflux Symptom Index (RSI) > 7 and, Reflux Finding Score (RFS) > 13

Exclusion Criteria

• Taken proton pump inhibitor within 3months
• Taken steroid within 3months
• Pregnancy
• Breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Proton pump inhibitor + prokinetics

Active Comparator group

Description:

Patient will be prescribed proton pump inhibitor (pantoprazole, 40mg, 1T QD) with prokinetics (Motilitone, 30mg, 1T, TID) for 3months.

Treatment:

Drug: Pantoprazole

Drug: Motilitone

Proton pump inhibitor + placebo

Placebo Comparator group

Description:

Patient will be prescribed proton pump inhibitor (pantoprazole, 40mg, 1T QD) with placebo (Motilitone, 30mg, 1T, TID) for 3months.

Treatment:

Drug: Placebo

Drug: Pantoprazole