Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge

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: NCT00562120
Recruitment Status : Completed
First Posted : November 21, 2007
Results First Posted : April 16, 2014
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Allergic Rhinitis
Interventions Drug: Placebo
Drug: Allegra
Drug: Allegra-D
Drug: PF-03654746
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-03654746 10 mg, Placebo, PF-03654746 1 mg, Allegra-D PF-03654746 1 mg, PF-03654746 10 mg, Allegra-D, Placebo Allegra-D, PF-03654746 1 mg, Placebo, PF-03654746 10 mg Placebo, Allegra-D, PF-03654746 10 mg, PF-03654746 1 mg
Hide Arm/Group Description PF-03654746 10 milligram (mg) capsule and Allegra (fexofenadine 60 mg) tablet-in-capsule along with placebo matched to Allegra-D (fexofenadine 60 mg in combination with pseudoephedrine 120 mg) tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period. PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule and Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period. Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period. Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
Period Title: First Intervention Period
Started 6 5 5 5
Treated 5 5 5 5
Completed 4 5 5 5
Not Completed 2 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0
Randomized but not Treated             1             0             0             0
Period Title: Washout Period 1 (At Least 14 Days)
Started 4 5 5 5
Completed 4 5 5 5
Not Completed 0 0 0 0
Period Title: Second Intervention Period
Started 4 5 5 5
Completed 4 5 5 5
Not Completed 0 0 0 0
Period Title: Washout Period 2 (At Least 14 Days)
Started 4 5 5 5
Completed 4 5 5 5
Not Completed 0 0 0 0
Period Title: Third Intervention Period
Started 4 5 5 5
Completed 4 5 5 5
Not Completed 0 0 0 0
Period Title: Washout Period 3 (At Least 14 Days)
Started 4 5 5 5
Completed 4 5 5 5
Not Completed 0 0 0 0
Period Title: Fourth Intervention Period
Started 4 5 5 5
Completed 4 5 5 5
Not Completed 0 0 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description All participants randomized to any treatment (PF-03654746 10 mg capsule first, PF-03654746 1 mg capsule first, Allegra-D tablet-in-capsule first and placebo first).
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Safety analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
18 to 44 years 15
45 to 64 years 5
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
12
  60.0%
Male
8
  40.0%
1.Primary Outcome
Title Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry
Hide Description Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hours (hrs) 10 minutes (min), 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin ‘post-allergen challenge’ measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single ‘post-allergen challenge’ value. Amin proportion was defined as ratio of ‘post-allergen challenge’ value and ‘Baseline/pre-allergen challenge value’. Diluent used was saline and allergen was short ragweed extract.
Time Frame 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.
Arm/Group Title PF-03654746 10 mg PF-03654746 1 mg Allegra-D Placebo
Hide Arm/Group Description:
PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Overall Number of Participants Analyzed 20 19 19 19
Mean (Standard Deviation)
Unit of Measure: ratio
0.760  (0.1504) 0.742  (0.2552) 0.717  (0.1935) 0.795  (0.3044)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Placebo
Comments An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.302
Comments P-value was based on one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Allegra-D, Placebo
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Placebo
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.229
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Allegra-D
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.544
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Allegra-D
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.710
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, PF-03654746 1 mg
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.816
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Nasal Volume Proportion Measured Using Acoustic Rhinometry
Hide Description Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Nasal volume at Baseline was defined as mean of 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume ‘post-allergen challenge’ measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single ‘post-allergen challenge’ value. Nasal volume proportion was defined as ratio of ‘post-allergen challenge’ value and ‘Baseline/pre-allergen challenge value’. Diluent used was saline and allergen was short ragweed extract.
Time Frame 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.
Arm/Group Title PF-03654746 10 mg PF-03654746 1 mg Allegra-D Placebo
Hide Arm/Group Description:
PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Overall Number of Participants Analyzed 20 19 19 19
Mean (Standard Deviation)
Unit of Measure: ratio
0.800  (0.1825) 0.796  (0.2641) 0.744  (0.1594) 0.856  (0.3859)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Placebo
Comments An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.269
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Allegra-D, Placebo
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.097
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Placebo
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.252
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Allegra-D
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.479
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Allegra-D
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.521
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, PF-03654746 1 mg
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.952
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Minimum Cross-Sectional Area (Amin) Maximum Fall Measured Using Acoustic Rhinometry
Hide Description Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of the 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin ‘post-allergen challenge’ measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall in Amin was calculated as baseline measure minus smallest ‘post-allergen challenge’ Amin measurement of the 3 measures.
Time Frame 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.
Arm/Group Title PF-03654746 10 mg PF-03654746 1 mg Allegra-D Placebo
Hide Arm/Group Description:
PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Overall Number of Participants Analyzed 20 19 19 19
Mean (Standard Deviation)
Unit of Measure: square centimeter (cm^2)
0.155  (0.0876) 0.157  (0.1159) 0.204  (0.0951) 0.190  (0.1510)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Placebo
Comments An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.130
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Allegra-D, Placebo
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.663
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Placebo
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.138
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Allegra-D
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Allegra-D
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, PF-03654746 1 mg
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.978
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Nasal Volume Maximum Fall Measured Using Acoustic Rhinometry
Hide Description Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Nasal volume at Baseline was defined as mean of the 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume ‘post-allergen challenge’ measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall for nasal volume was calculated as baseline measure minus smallest ‘post-allergen challenge’ nasal volume measurement among the 3 measures.
Time Frame 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.
Arm/Group Title PF-03654746 10 mg PF-03654746 1 mg Allegra-D Placebo
Hide Arm/Group Description:
PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Overall Number of Participants Analyzed 20 19 19 19
Mean (Standard Deviation)
Unit of Measure: cubic centimeter (cm^3)
3.132  (2.4120) 3.244  (2.3676) 4.443  (2.9502) 3.275  (2.7001)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Placebo
Comments An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.357
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Allegra-D, Placebo
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.952
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Placebo
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.480
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Allegra-D
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Allegra-D
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, PF-03654746 1 mg
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.753
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea
Hide Description Nasal symptoms included; nasal congestion: participants rated sensation of nasal blockage on 0 (no blockage) to 5 (total blockage) scale, nasal itching: participants rated sensation of nasal itch on 0 (no itch) to 5 (very itchy) scale, rhinorrhea: participants rated sensation of runny nose on 0 (no running) to 5 (very runny) scale. Symptom scores were assessed as mean of each intervention period at specified time-points for ‘post-diluent, pre-allergen challenge’ measure and ‘post-challenge’ measure. Post-diluent, pre-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and post-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period and (for congestion only) 3 hrs 40 min post PF-03654746/placebo dose (Post-oxymetazoline) at each intervention period.
Time Frame 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Pre-allergen challenge); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose (Post-allergen challenge); 3 hrs 40 min post dose (Post-oxymetazoline) on Day 1 of each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.
Arm/Group Title PF-03654746 10 mg PF-03654746 1 mg Allegra-D Placebo
Hide Arm/Group Description:
PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Overall Number of Participants Analyzed 20 19 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Nasal congestion: Pre-allergen challenge 0.2  (0.36) 0.4  (0.42) 0.4  (0.57) 0.4  (0.59)
Nasal congestion: Post-allergen challenge 1.5  (1.20) 1.8  (1.30) 1.9  (1.42) 2.2  (1.48)
Nasal congestion: Post-oxymetazoline 0.8  (1.16) 0.8  (1.21) 0.9  (0.85) 0.9  (1.20)
Nasal Itching: Pre-allergen challenge 0.0  (0.07) 0.1  (0.23) 0.0  (0.08) 0.1  (0.31)
Nasal Itching: Post-allergen challenge 0.4  (0.71) 0.8  (1.10) 0.9  (1.12) 1.4  (1.43)
Rhinorrhea: Pre-allergen challenge 0.1  (0.23) 0.1  (0.17) 0.2  (0.39) 0.1  (0.33)
Rhinorrhea: Post-allergen challenge 0.6  (1.01) 1.1  (1.48) 1.3  (1.30) 1.9  (1.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Placebo
Comments Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Allegra-D, Placebo
Comments Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.127
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Placebo
Comments Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Allegra-D
Comments Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.218
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Allegra-D
Comments Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.905
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, PF-03654746 1 mg
Comments Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.273
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Placebo
Comments Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Allegra-D, Placebo
Comments Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Placebo
Comments Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Allegra-D
Comments Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Allegra-D
Comments Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.496
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, PF-03654746 1 mg
Comments Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.190
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Placebo
Comments Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Allegra-D, Placebo
Comments Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Placebo
Comments Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Allegra-D
Comments Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.061
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Allegra-D
Comments Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.778
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, PF-03654746 1 mg
Comments Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Nasal Symptom Scores: Sneezing
Hide Description The absolute number of sneezes was recorded by the participants under supervision of study personnel. Nasal symptom score for sneezing was assessed as the total number of sneezes of each intervention period at specified time-points for the post-diluent and post-challenge and post where ‘post-diluent, pre-allergen challenge’ included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and ‘post-allergen challenge’ included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period.
Time Frame 2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.
Arm/Group Title PF-03654746 10 mg PF-03654746 1 mg Allegra-D Placebo
Hide Arm/Group Description:
PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Overall Number of Participants Analyzed 20 19 19 19
Mean (Standard Deviation)
Unit of Measure: sneezes
Sneezing: Pre-allergen challenge 0.0  (0.07) 0.1  (0.23) 0.1  (0.61) 0.1  (0.17)
Sneezing: Post-allergen challenge 0.7  (1.54) 0.6  (0.92) 1.2  (1.94) 3.6  (3.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Placebo
Comments An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Allegra-D, Placebo
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Placebo
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments P-value was based on a one-sided test. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, Allegra-D
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.217
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-03654746 1 mg, Allegra-D
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.156
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-03654746 10 mg, PF-03654746 1 mg
Comments An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.848
Comments P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.
Method ANOVA
Comments [Not Specified]
7.Other Pre-specified Outcome
Title Serum PF-03654746 Concentration
Hide Description Only participants receiving PF-03654746 were analyzed for this outcome measure. Mean serum concentration of PF-03654746 was calculated of each intervention period.
Time Frame 1 hr 30 min post dose on Day 1 of each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.
Arm/Group Title PF-03654746 10 mg PF-03654746 1 mg
Hide Arm/Group Description:
PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
34.16  (17.85) 2.78  (1.55)
Time Frame [Not Specified]
Adverse Event Reporting Description All participants included in safety analysis set were evaluable for adverse events. Participants at risk = 20, 19, 19, 19 for each arm group, respectively.
 
Arm/Group Title PF-03654746 10 mg PF-03654746 1 mg Allegra-D Placebo
Hide Arm/Group Description PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods. Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
All-Cause Mortality
PF-03654746 10 mg PF-03654746 1 mg Allegra-D Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PF-03654746 10 mg PF-03654746 1 mg Allegra-D Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%)   0/19 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PF-03654746 10 mg PF-03654746 1 mg Allegra-D Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/20 (25.00%)   2/19 (10.53%)   0/19 (0.00%)   2/19 (10.53%) 
General disorders         
Feeling jittery * 1  1/20 (5.00%)  0/19 (0.00%)  0/19 (0.00%)  0/19 (0.00%) 
Infections and infestations         
Bronchitis * 1  0/20 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  0/19 (0.00%) 
Gastroenteritis * 1  1/20 (5.00%)  0/19 (0.00%)  0/19 (0.00%)  0/19 (0.00%) 
Sinusitis * 1  0/20 (0.00%)  1/19 (5.26%)  0/19 (0.00%)  0/19 (0.00%) 
Urinary tract infection * 1  1/20 (5.00%)  0/19 (0.00%)  0/19 (0.00%)  1/19 (5.26%) 
Viral upper respiratory tract infection * 1  0/20 (0.00%)  0/19 (0.00%)  0/19 (0.00%)  1/19 (5.26%) 
Metabolism and nutrition disorders         
Anorexia * 1  1/20 (5.00%)  0/19 (0.00%)  0/19 (0.00%)  0/19 (0.00%) 
Psychiatric disorders         
Disorientation * 1  1/20 (5.00%)  0/19 (0.00%)  0/19 (0.00%)  0/19 (0.00%) 
Hallucination * 1  1/20 (5.00%)  0/19 (0.00%)  0/19 (0.00%)  0/19 (0.00%) 
Insomnia * 1  2/20 (10.00%)  1/19 (5.26%)  0/19 (0.00%)  0/19 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00562120     History of Changes
Other Study ID Numbers: A8801003
First Submitted: November 19, 2007
First Posted: November 21, 2007
Results First Submitted: March 10, 2014
Results First Posted: April 16, 2014
Last Update Posted: April 16, 2014