NCT02530879 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Fusconi M, De Virgilio A, Conte M, Colicchio MG, Gallo A, Greco A, Ralli G, de Vincentiis M
The importance of the number of reflux episodes in the diagnosis of laryngopharyngeal reflux disease. Otolaryngol Head Neck Surg. 2013 Feb;148(2):261-6. doi: 10.1177/0194599812466534. Epub 2012 Nov 2.
Hicks DM, Ours TM, Abelson TI, Vaezi MF, Richter JE
The prevalence of hypopharynx findings associated with gastroesophageal reflux in normal volunteers. J Voice. 2002 Dec;16(4):564-79.
Karkos PD, Wilson JA
Empiric treatment of laryngopharyngeal reflux with proton pump inhibitors: a systematic review. Laryngoscope. 2006 Jan;116(1):144-8. Review.
Koufman JA, Aviv JE, Casiano RR, Shaw GY
Laryngopharyngeal reflux: position statement of the committee on speech, voice, and swallowing disorders of the American Academy of Otolaryngology-Head and Neck Surgery. Otolaryngol Head Neck Surg. 2002 Jul;127(1)
Park JO, Shim MR, Hwang YS, Cho KJ, Joo YH, Cho JH, Nam IC, Kim MS, Sun DI
Combination of voice therapy and antireflux therapy rapidly recovers voice-related symptoms in laryngopharyngeal reflux patients. Otolaryngol Head Neck Surg. 2012 Jan;146(1):92-7.

Comparison of Voice Therapy and Antireflex Therapy in the Treatment of Laryngopharyngeal Reflux-related Hoarseness: A Prospective Randomized Control Trial

Details for clinical trial NCT02530879

Clinical trial NCT02530879 - References