Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170001
Status:
COMPLETED
Last Update Posted:
2011-12-15
First Post:
2005-09-12
Brief Title:
Which Supraesophageal Reflux Symptoms Reliably Respond to Proton-Pump-Inhibitor PPI Therapy
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Which Supraesophageal Reflux Symptoms Reliably Respond to PPI Therapy A Large Simple Trial
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators hypothesize that persons with the particular cluster of symptoms that are due to supraesophageal reflux SER will have complete resolution of those symptoms with adequate acid suppression when a PPI is administered for 6 months
Detailed Description:
Estimates suggest that up to 50 of Voice Clinic patients and 10 of ENT and Pulmonology outpatients seek medical care for chronic laryngopharyngeal symptoms resulting from supraesophageal reflux SER While many anecdotal and uncontrolled studies have shown significant clinical benefit with Proton Pump Inhibitors PPIs this conclusion has not been supported in small randomized placebo-controlled studies The recent negative Vaezi trial unpublished was limited by bias introduced in the patient enrollment process due to reliance on physician diagnosis of SER This bias became clear during conduction of the Supraesophageal Reflux Questionnaire SRQ Validation Study Mayo in press which demonstrated that Otolaryngologists vary in their threshold for considering the diagnosis of SER This project aims to remove selection bias from the study design
HypothesesQuestions Our underlying assumptions are as follows SER is due to the passage of gastric contents into the esophagus and with adequate acid suppression provided by a PPI there is less overall volume available to reflux which should improve SER We hypothesize that persons with the particular cluster of symptoms that are due to SER will have complete resolution of those symptoms with adequate acid suppression when PPI is administered for an adequate duration of time
Primary Aim
To determine which symptoms chronic cough hoarseness sore throat globus sensation or throat clearing are completely ameliorated with PPI therapy and hence reflective of SER
Secondary Aims
To determine which features of a patients history are predictive of a positive response to PPI therapy and which confer lack of response and
To develop a scoring system for the SRQ that would predict a diagnosis of SER
Methods
Design Large simple randomized double-blind placebo-controlled trial of subjects with chronic laryngopharyngeal symptoms
Population Subjects will be recruited from Olmsted County and from General ENT Clinic and Pulmonary Chronic Cough Clinic
Inclusion Criteria Subjects must have at least 1 of 5 chronic present for at least one month and recurrent at least twice per week symptoms of interest
Randomization A dynamic allocation algorithm will be used by the Mayo Pharmacy to balance the treatment arms for confounding variables for treatment allocation
Study Intervention Either twice daily esomeprazole 40 mg or placebo for 6 months Beyond a urine pregnancy test for women of child-bearing age no other examination is required for enrollment or participation
Follow-Up Subjects will be contacted by phone monthly to assess symptoms check compliance and adverse events
Primary Outcome True responders will be those subjects who lack at least one of their initial symptoms by the 3-month time period and remain asymptomatic at 4 5 and 6 months
Sample Size Based on previous studies we anticipate a 30-40 placebo response rate at 3 months that will not be sustained at 6 months We expect roughly 60 to completely respond to PPI therapy ie 40 do not completely respond Assuming 140 patients do not completely respond we would need 350 patients on PPI therapy Hence 70 subjects will be randomized to receive PPI therapy and 30 randomized to placebo for each symptom group for a total N500
Analysis Logistic regression
Significance This project will identify patients with laryngopharyngeal symptoms most likely to benefit from empiric PPI therapy Until we have clarified which symptoms best respond and do not respond to therapy we are bound to repeat the errors of the past Finally this project will further validate the SRQ for use in future trials
HypothesesQuestions Our underlying assumptions are as follows SER is due to the passage of gastric contents into the esophagus and with adequate acid suppression provided by a PPI there is less overall volume available to reflux which should improve SER We hypothesize that persons with the particular cluster of symptoms that are due to SER will have complete resolution of those symptoms with adequate acid suppression when PPI is administered for an adequate duration of time
Primary Aim
To determine which symptoms chronic cough hoarseness sore throat globus sensation or throat clearing are completely ameliorated with PPI therapy and hence reflective of SER
Secondary Aims
To determine which features of a patients history are predictive of a positive response to PPI therapy and which confer lack of response and
To develop a scoring system for the SRQ that would predict a diagnosis of SER
Methods
Design Large simple randomized double-blind placebo-controlled trial of subjects with chronic laryngopharyngeal symptoms
Population Subjects will be recruited from Olmsted County and from General ENT Clinic and Pulmonary Chronic Cough Clinic
Inclusion Criteria Subjects must have at least 1 of 5 chronic present for at least one month and recurrent at least twice per week symptoms of interest
Randomization A dynamic allocation algorithm will be used by the Mayo Pharmacy to balance the treatment arms for confounding variables for treatment allocation
Study Intervention Either twice daily esomeprazole 40 mg or placebo for 6 months Beyond a urine pregnancy test for women of child-bearing age no other examination is required for enrollment or participation
Follow-Up Subjects will be contacted by phone monthly to assess symptoms check compliance and adverse events
Primary Outcome True responders will be those subjects who lack at least one of their initial symptoms by the 3-month time period and remain asymptomatic at 4 5 and 6 months
Sample Size Based on previous studies we anticipate a 30-40 placebo response rate at 3 months that will not be sustained at 6 months We expect roughly 60 to completely respond to PPI therapy ie 40 do not completely respond Assuming 140 patients do not completely respond we would need 350 patients on PPI therapy Hence 70 subjects will be randomized to receive PPI therapy and 30 randomized to placebo for each symptom group for a total N500
Analysis Logistic regression
Significance This project will identify patients with laryngopharyngeal symptoms most likely to benefit from empiric PPI therapy Until we have clarified which symptoms best respond and do not respond to therapy we are bound to repeat the errors of the past Finally this project will further validate the SRQ for use in future trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRUSESOM0376 | None | None | None |