Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux
This study has been terminated.
(Pharmaceutical company purchased by another company and funding was terminated.)
Sponsor:
American Institute for Voice and Ear Research
Information provided by (Responsible Party):
Robert T. Sataloff, MD, American Institute for Voice and Ear Research
ClinicalTrials.gov Identifier:
NCT00369265
First received: August 24, 2006
Last updated: August 23, 2012
Last verified: August 2012
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Results First Received: July 11, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment |
| Condition: |
Laryngopharyngeal Reflux |
| Interventions: |
Drug: Lansoprazole Dietary Supplement: Sugar pill |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Inadequate recruitment during this study; therefore, the study was terminated. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Sugar Pill | Placebo for Lansoprazole twice daily |
| Lansoprazole | Lansoprazole 30 mg twice daily |
Participant Flow: Overall Study
| Sugar Pill | Lansoprazole | |
|---|---|---|
| STARTED | 4 | 7 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 4 | 7 |
| Study terminated | 4 | 7 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Sugar Pill | Placebo for Lansoprazole twice daily |
| Lansoprazole | Lansoprazole 30 mg twice daily |
| Total | Total of all reporting groups |
Baseline Measures
| Sugar Pill | Lansoprazole | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
4 | 7 | 11 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 6 | 10 |
| >=65 years | 0 | 1 | 1 |
|
Age
[units: years] Mean ± Standard Deviation |
33.0 ± 11.56 | 40.1 ± 17.33 | 37.5 ± 15.83 |
|
Gender
[units: participants] |
|||
| Female | 3 | 6 | 9 |
| Male | 1 | 1 | 2 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 4 | 7 | 11 |
Outcome Measures
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
Publications:
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| The study was terminated due to inadequate subject recruitment. |
Results Point of Contact:
Name/Title: Robert T. Sataloff, M.D., D.M.A., FACS
Organization: Philadelphia ENT Associates
phone: 215-545-3322
e-mail: rtsataloff@phillyent.com
Organization: Philadelphia ENT Associates
phone: 215-545-3322
e-mail: rtsataloff@phillyent.com
Publications:
| Responsible Party: | Robert T. Sataloff, MD, American Institute for Voice and Ear Research |
| ClinicalTrials.gov Identifier: | NCT00369265 History of Changes |
| Other Study ID Numbers: | 10166 |
| Study First Received: | August 24, 2006 |
| Results First Received: | July 11, 2012 |
| Last Updated: | August 23, 2012 |
| Health Authority: | United States: Institutional Review Board |