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Efficacy of Lansoprazole in Chronic Post Nasal Drip (PND)

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: NCT00335283
Recruitment Status : Completed
First Posted : June 9, 2006
Results First Posted : August 21, 2012
Last Update Posted : August 21, 2012
Sponsor:
Collaborator:
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Larynx Disease
Interventions Drug: Lansoprazole Tablet
Procedure: PH and impedence testing
Procedure: manometry
Drug: lansoprazole
Drug: placebo
Enrollment 75
Recruitment Details The PI and/or study coordinator or other GI research nurses will meet with the patients referred by Vanderbilt's Asthma, Sinus and Allergy Program. The patients will be given the consent form to read, the document will be reviewed, and all questions will be answered.
Pre-assignment Details  
Arm/Group Title Lansoprazole Placebo (Sugar Pill)
Hide Arm/Group Description 40 mg twice a day one tablet twice a day
Period Title: Overall Study
Started 36 39
Completed 30 34
Not Completed 6 5
Arm/Group Title Lansoprazole Placebo (Sugar Pill) Total
Hide Arm/Group Description 40 mg twice a day one tablet twice a day Total of all reporting groups
Overall Number of Baseline Participants 36 39 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 39 participants 75 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
  91.7%
36
  92.3%
69
  92.0%
>=65 years
3
   8.3%
3
   7.7%
6
   8.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 39 participants 75 participants
46  (15) 45  (13) 45  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 39 participants 75 participants
Female
30
  83.3%
26
  66.7%
56
  74.7%
Male
6
  16.7%
13
  33.3%
19
  25.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants 39 participants 75 participants
36 39 75
1.Primary Outcome
Title Post Nasal Drainage Symptom Response
Hide Description The primary outcome measure was postnasal drainage symptom response measured by using a visual analogue scale. At 8 and 16 weeks, a horizontal symptoms scale from 0% (no change) to 100% (symptoms completely resolved) was presented to participants to assess improvement in postnasal drainage symptoms.
Time Frame 8 and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.
Arm/Group Title Lansoprazole Placebo (Sugar Pill)
Hide Arm/Group Description:
40 mg twice a day
one tablet twice a day
Overall Number of Participants Analyzed 30 34
Median (Inter-Quartile Range)
Unit of Measure: Scores on a Scale
8 week
55
(12.5 to 80)
3.5
(0 to 53.8)
16 week
50
(10 to 72)
5
(0 to 40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole, Placebo (Sugar Pill)
Comments This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .01
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 3.12
Confidence Interval (2-Sided) 95%
1.28 to 7.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lansoprazole, Placebo (Sugar Pill)
Comments This applies to the 16 week treatment affect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .006
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
1.41 to 8.67
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Rhinosinusitis Outcome Measure(RSOM-31)
Hide Description RSOM-31 includes 31 questions combined into a total score ranging from 0 to 155 with higher scores representing greater disease burden. Values are based on patient report.
Time Frame Baseline, 8 weeks, and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.
Arm/Group Title Lansoprazole Placebo (Sugar Pill)
Hide Arm/Group Description:
40 mg twice a day
one tablet twice a day
Overall Number of Participants Analyzed 30 34
Median (Inter-Quartile Range)
Unit of Measure: Scores on a Scale
Baseline
63
(50 to 93)
51
(38 to 69)
8 weeks
40
(23 to 65)
36
(20 to 60)
16 weeks
35
(21 to 61)
35
(23 to 55)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole, Placebo (Sugar Pill)
Comments This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .97
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.38 to 2.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lansoprazole, Placebo (Sugar Pill)
Comments This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .84
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.40 to 3.06
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Sino Nasal Outcome Test (SNOT-20)
Hide Description SNOT-20 includes 20 questions combined into a total score ranging from 0 to 100 with higher numbers representing greater rhinosinusitis health burden and represents patient-reported symptom severity.
Time Frame Baseline, 8 weeks and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.
Arm/Group Title Lansoprazole Placebo (Sugar Pill)
Hide Arm/Group Description:
40 mg twice a day
one tablet twice a day
Overall Number of Participants Analyzed 30 34
Median (Inter-Quartile Range)
Unit of Measure: Scores on a Scale
Baseline
36
(31 to 52)
35
(31 to 45)
8 weeks
25
(17 to 35)
32
(17 to 39)
16 weeks
20
(19 to 40)
27
(16 to 38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole, Placebo (Sugar Pill)
Comments This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .06
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 2.44
Confidence Interval (2-Sided) 95%
.95 to 6.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lansoprazole, Placebo (Sugar Pill)
Comments This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .007
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 4.51
Confidence Interval (2-Sided) 95%
1.5 to 13.6
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Quality of Life Questionnaire (QOLRAD)
Hide Description The patient-reported QOLRAD consists of 25 questions combined into a total score ranging from 25 to 175 with higher numbers representing better quality of life.
Time Frame Baseline, 8 weeks and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.
Arm/Group Title Lansoprazole Placebo (Sugar Pill)
Hide Arm/Group Description:
40 mg twice a day
one tablet twice a day
Overall Number of Participants Analyzed 30 34
Median (Inter-Quartile Range)
Unit of Measure: Scores on a Scale
Baseline
155
(126 to 169)
160
(142 to 170)
8 weeks
174
(157 to 175)
155
(148 to 170)
16 weeks
173
(158 to 174)
160
(146 to 172)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole, Placebo (Sugar Pill)
Comments This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .006
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 5.17
Confidence Interval (2-Sided) 95%
2.02 to 13.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lansoprazole, Placebo (Sugar Pill)
Comments This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 5.31
Confidence Interval (2-Sided) 95%
1.97 to 14.3
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lansoprazole Placebo (Sugar Pill)
Hide Arm/Group Description 40 mg twice a day one tablet twice a day
All-Cause Mortality
Lansoprazole Placebo (Sugar Pill)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Lansoprazole Placebo (Sugar Pill)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/39 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lansoprazole Placebo (Sugar Pill)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/39 (0.00%) 
Sample size of 75 participants is small. Lack of an objective measure of postnasal drainage limited the study outcome to be symptom based.
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: Manager, Clinical Trials
Organization: Vanderbilt University Medical Center
Phone: 615-322-4643
EMail: tina.higginbotham@vanderbilt.edu
Layout table for additonal information
Responsible Party: Michael Vaezi, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00335283    
Other Study ID Numbers: 051169
First Submitted: June 7, 2006
First Posted: June 9, 2006
Results First Submitted: March 28, 2011
Results First Posted: August 21, 2012
Last Update Posted: August 21, 2012