Trial record 22 of 135 for:
AMITRIPTYLINE
Trial of the Treatment of Chronic Laryngitis With Amitryptiline
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ClinicalTrials.gov Identifier: NCT02434523 |
Recruitment Status :
Terminated
(concern regarding study design)
First Posted : May 5, 2015
Results First Posted : November 30, 2016
Last Update Posted : November 30, 2016
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Sponsor:
Boston Medical Center
Collaborator:
American Laryngological Association
Information provided by (Responsible Party):
J Pieter Noordzij, Boston Medical Center
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Tracking Information | |||||
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First Submitted Date ICMJE | April 22, 2015 | ||||
First Posted Date ICMJE | May 5, 2015 | ||||
Results First Submitted Date ICMJE | March 29, 2016 | ||||
Results First Posted Date ICMJE | November 30, 2016 | ||||
Last Update Posted Date | November 30, 2016 | ||||
Study Start Date ICMJE | September 2013 | ||||
Actual Primary Completion Date | January 2015 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Reflux Symptom Index [ Time Frame: 8 weeks ] Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT02434523 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Trial of the Treatment of Chronic Laryngitis With Amitryptiline | ||||
Official Title ICMJE | Double-blind Placebo Controlled Trial of the Treatment of Chronic Laryngitis With Amitryptiline | ||||
Brief Summary | The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis. | ||||
Detailed Description | The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis. At the baseline visit, subjects will be assigned at random to amitriptyline or placebo which they will take for 8 weeks. Subjects will be seen in the clinic at baseline and at 8 weeks. Improvement will be measured using standardized symptom scales, and a self-reported subjective improvement percentage. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE |
80 | ||||
Actual Study Completion Date ICMJE | January 2015 | ||||
Actual Primary Completion Date | January 2015 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 64 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02434523 | ||||
Other Study ID Numbers ICMJE | H-29925 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | J Pieter Noordzij, Boston Medical Center | ||||
Study Sponsor ICMJE | Boston Medical Center | ||||
Collaborators ICMJE | American Laryngological Association | ||||
Investigators ICMJE |
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PRS Account | Boston Medical Center | ||||
Verification Date | October 2016 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |