Laryngopharyngeal Reflux Disease Clinical Trial
Official title:
Randomized Controlled Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease
| Verified date | May 2016 |
| Source | Samsung Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Korea: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | January 2017 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Samsung Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Samsung Medical Center |
Korea, Republic of,
Glicksman JT, Mick PT, Fung K, Carroll TL. Prokinetic agents and laryngopharyngeal reflux disease: Prokinetic agents and laryngopharyngeal reflux disease: a systematic review. Laryngoscope. 2014 Oct;124(10):2375-9. doi: 10.1002/lary.24738. Epub 2014 Jun 1 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reflux symptom index (questionnaire) | Reflux symptom index is validated questionnaire for laryngopharyngeal reflux disease. It consists of 9 items, and scale of each item ranges from 0 to 5 with maximal total score of 45. | 1 month after medication | No |
| Primary | Reflux finding score (scoring of laryngeal stroboscopy finding score) | Reflux finding score is an 8-item clinical severity scale based on findings during laryngeal stroboscopy. The scale ranges from 0 (no abnormal findings) to a maximum of 26 (worst score possible). | 1 month after medication | No |
| Secondary | Reflux symptom index (questionnaire) | Reflux symptom index is validated questionnaire for laryngopharyngeal reflux disease. It consists of 9 items, and scale of each item ranges from 0 to 5 with maximal total score of 45. | 3 months after medication | No |
| Secondary | Reflux finding score (scoring of laryngeal stroboscopy finding score) | Reflux finding score is an 8-item clinical severity scale based on findings during laryngeal stroboscopy. The scale ranges from 0 (no abnormal findings) to a maximum of 26 (worst score possible). | 3 months after medication | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05871398 -
The Efficacy of Potassium-competitive Acid Blocker in Patients With Laryngopharyngeal Reflux Disease
|
Phase 3 |