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Trial record 6 of 9 for:    MECLIZINE

Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00641797
Recruitment Status : Completed
First Posted : March 24, 2008
Results First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
David Burmeister, Lehigh Valley Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Care Provider);   Primary Purpose: Treatment
Condition Benign Paroxysmal Positional Vertigo
Interventions Drug: Meclizine
Other: Epley Maneuver
Drug: Lorazepam
Drug: Diphenhydramine
Drug: Ondansetron
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1, Conventional Therapy Arm 2, Epley Maneuver
Hide Arm/Group Description

Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).

Meclizine: medication administration 25mg PO one time

Lorazepam: Lorazepam 1 - 5mg PO/IV prn

Diphenhydramine: 25 - 50mg PO/IV once prn

Ondansetron: Ondansetron 4 - 8 mg PO/IV prn

Patients will receive vestibular rehabilitation (the Epley Maneuver).

Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver.

Period Title: Overall Study
Started 11 15
Completed 11 15
Not Completed 0 0
Arm/Group Title Arm 1, Conventional Therapy Arm 2, Epley Maneuver Total
Hide Arm/Group Description

Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).

Meclizine: medication administration 25mg PO one time

Lorazepam: Lorazepam 1 - 5mg PO/IV prn

Diphenhydramine: 25 - 50mg PO/IV once prn

Ondansetron: Ondansetron 4 - 8 mg PO/IV prn

Patients will receive vestibular rehabilitation (the Epley Maneuver).

Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver.

Total of all reporting groups
Overall Number of Baseline Participants 11 15 26
Hide Baseline Analysis Population Description
To be included in the study, patients had to be at least 18 years of age, presenting to the ED weekdays during business hours, and have a positive DH test.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 15 participants 26 participants
59  (12.6) 64  (11.2) 61.5  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 15 participants 26 participants
Female
3
  27.3%
10
  66.7%
13
  50.0%
Male
8
  72.7%
5
  33.3%
13
  50.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 11 participants 15 participants 26 participants
11
 100.0%
15
 100.0%
26
 100.0%
1.Primary Outcome
Title Likert Scale for Satisfaction
Hide Description The Likert Scale measured patient satisfaction on a 0-10 score range (0 = Least Satisfied; 10 = Most Satisfied).
Time Frame 0 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1, Conventional Therapy Arm 2, Epley Maneuver
Hide Arm/Group Description:

Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).

Meclizine: medication administration 25mg PO one time

Lorazepam: Lorazepam 1 - 5mg PO/IV prn

Diphenhydramine: 25 - 50mg PO/IV once prn

Ondansetron: Ondansetron 4 - 8 mg PO/IV prn

Patients will receive vestibular rehabilitation (the Epley Maneuver).

Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver.

Overall Number of Participants Analyzed 11 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
9  (1.5) 9  (1.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1, Conventional Therapy Arm 2, Epley Maneuver
Hide Arm/Group Description

Patients will receive standard conventional medication therapy (i.e., meclizine, diphenhydramine, lorazepam, ondansetron).

Meclizine: medication administration 25mg PO one time

Lorazepam: Lorazepam 1 - 5mg PO/IV prn

Diphenhydramine: 25 - 50mg PO/IV once prn

Ondansetron: Ondansetron 4 - 8 mg PO/IV prn

Patients will receive vestibular rehabilitation (the Epley Maneuver).

Epley Maneuver: Patient has vestibular rehabilitation utilizing the Epley Maneuver.

All-Cause Mortality
Arm 1, Conventional Therapy Arm 2, Epley Maneuver
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1, Conventional Therapy Arm 2, Epley Maneuver
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1, Conventional Therapy Arm 2, Epley Maneuver
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Regina Sacco, DPT, BA, BHSC
Organization: Lehigh Valley Health Network
Phone: 610-969-0300
EMail: Regina_R.Sacco@lvhn.org
Layout table for additonal information
Responsible Party: David Burmeister, Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT00641797     History of Changes
Other Study ID Numbers: 2-2006123IRB#
First Submitted: February 13, 2008
First Posted: March 24, 2008
Results First Submitted: September 19, 2017
Results First Posted: April 3, 2018
Last Update Posted: April 3, 2018