Which Supraesophageal Reflux Symptoms Reliably Respond to Proton-Pump-Inhibitor (PPI) Therapy
This study has been completed.
Sponsor:
Mayo Clinic
Collaborator:
AstraZeneca
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00170001
First received: September 12, 2005
Last updated: December 13, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Gastroesophageal Reflux |
Drug: Nexium Drug: Sugar Pill |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Which Supraesophageal Reflux Symptoms Reliably Respond to PPI Therapy: A Large Simple Trial |
Resource links provided by NLM:
MedlinePlus related topics:
GERD
Drug Information available for:
Omeprazole
Omeprazole magnesium
Esomeprazole
Esomeprazole Sodium
Esomeprazole magnesium
U.S. FDA Resources
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- To determine which symptom(s) are predictive of SER based on a complete response to PPI therapy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine which symptoms demonstrate partial response with PPI therapy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- To determine which features of a patient's history are predictive of a positive response to PPI therapy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- To determine which features of a patient's history are predictive of a lack of response to PPI therapy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- To develop a scoring system for the Supraesophageal Reflux Questionnaire (SRQ) that would predict a diagnosis of SER [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 500 |
| Study Start Date: | April 2005 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Sugar pill |
Drug: Sugar Pill
40 mg BID
|
| Active Comparator: Active Comparator |
Drug: Nexium
40 mg bid dosing
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Primary complaint includes one of the following symptoms: chronic cough (dry, hacking, or nocturnal), hoarseness, sore throat, globus sensation, or throat clearing. These symptoms will be identified by a yes response to SRQ (Appendix 7) items 2, 3, 4, 5, 6, and 8. Furthermore, symptom(s) must be chronic (present for at least 1 month), and recurrent (at least twice per week). These criteria correspond to SRQ columns on page 3-5. The first column asks: When in your life did you first notice this symptom? A response with either number 2, 3, 4, or 5 meets criteria for chronic. The second column asks: How frequently have you noticed the symptom? A response with either number 3, 4, or 5 meets criteria for recurrent.
Exclusion Criteria:
- History of head and neck cancer/radiation/surgery (SRQ items 15, 16, 17)
- History of esophagus/stomach surgery (SRQ item 22)
- Peptic or duodenal ulcer disease; stomach or gastric ulcer disease; history of esophageal stricture, or Barrett's esophagus, or esophagitis, or tumor of the esophagus or stomach (SRQ item 23 and review of electronic surgical records of Mayo Clinic patients)
- Presence of alarm symptoms (hemoptysis, unexplained loss of 10 or more pounds in the past 3 months), obtained from Appendix 5 for Community Subjects, medical record for clinic subjects. History of dysphagia, defined as a yes answer to SRQ item 7.
- PPI use within 4 weeks, obtained from Appendix 5 for Community Subjects, medical record for clinic subjects
- Use of warfarin or digoxin, obtained from Appendix 5 for Community Subjects, medical record for clinic subjects
- Pregnancy at the time of enrollment, based on urine pregnancy test
- Inability to understand or read English at a 6th grade level
- Residence outside of the United States of America (USA)
- Age younger than 18 years old
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. Yvonne Romero, Mayo Clinic Rochester, MN |
| ClinicalTrials.gov Identifier: | NCT00170001 History of Changes |
| Other Study ID Numbers: | 452-05, IRUSESOM0376 |
| Study First Received: | September 12, 2005 |
| Last Updated: | December 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mayo Clinic:
|
supraesophageal reflux laryngopharyngeal symptoms pharynx esophagus |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases |
Digestive System Diseases Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013