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Trial record 5 of 179 for:    "Panic Disorder"

A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder

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ClinicalTrials.gov Identifier: NCT00677352
Recruitment Status : Completed
First Posted : May 14, 2008
Results First Posted : May 6, 2011
Last Update Posted : May 20, 2011
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Panic Disorder
Interventions Drug: sertraline
Drug: Paroxetine
Enrollment 321
Recruitment Details Participants were screened at 34 centers in Japan.
Pre-assignment Details Subjects who experienced at least one panic attack that met the DSM-IV diagnostic criteria per week between the start of the washout/observation period and the start of the double-blind treatment period and who had a total score of 18 or higher on the Panic and Agoraphobia Scale at the start of the double-blind treatment period.
Arm/Group Title Sertraline Paroxetine
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Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.

At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks.

Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.

At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks.

Period Title: Treatment Phase
Started 157 [1] 164 [2]
Completed 132 122
Not Completed 25 42
Reason Not Completed
Adverse Event             14             22
Lack of Efficacy             2             3
Lost to Follow-up             0             1
Withdrawal by Subject             7             7
Physician Decision             1             0
Pregnancy             0             1
Protocol Violation             1             1
Transference or work related matter             0             5
Not treated             0             2
[1]
All 157 subjects were treated with Sertraline.
[2]
2 subjects were not teated, therefore 162 subjects were treated with paroxetine.
Period Title: Tapering Phase
Started 132 122
Completed 126 112
Not Completed 6 10
Reason Not Completed
Adverse Event             1             5
Withdrawal by Subject             5             3
Pregnancy             0             1
Job transfer             0             1
Arm/Group Title Sertraline Paroxetine Total
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Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.

At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks.

Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.

At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 157 162 319
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 157 participants 162 participants 319 participants
< 18 years 0 0 0
18 - 44 years 119 126 245
45 -64 years 38 36 74
>= 65 years 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 162 participants 319 participants
Female
113
  72.0%
109
  67.3%
222
  69.6%
Male
44
  28.0%
53
  32.7%
97
  30.4%
1.Primary Outcome
Title Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase
Hide Description Panic and Agoraphobia Scale has 13 items with a 5-point scale (range: 0 to 4). The total possible score is ranged from 0 to 52. The increasing value are considered worse outcome. The scale is grouped into 5 subscores (not including item U in total score): panic attacks ; agoraphobia/avoidance behavior ; anticipatory anxiety; disability; and health worries. Four point difference in reduction of the PAS total score has been identified as not clinically meaningful in the assessment of Panic Disorder symptomatology.
Time Frame Baseline and 12 weeks
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Hide Analysis Population Description

Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.

Last Observation Carried Forward

Arm/Group Title Sertraline Paroxetine
Hide Arm/Group Description:

Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.

At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks.

Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.

At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks.

Overall Number of Participants Analyzed 127 127
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on scale
-17.4
(-18.9 to -15.9)
-17.0
(-18.4 to -15.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Paroxetine
Comments The two-sided 95% confidence interval (CI) of the intergroup difference (sertraline group – paroxetine group) of the mean reduction in the PAS total score at each dose during the treatment phase was calculated using an analysis of covariance (ANCOVA) model with treatment group as a factor and baseline PAS total score as a covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sertraline was concluded to be non-inferior to paroxetine when the upper limit of the CI fell below the non-inferiority margin of 4.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-2.5 to 1.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement
Hide Description

The ratings were rated to compare with baseline by 7-point " 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse".

Responder was defined as number of participants who were assessed as "very much improved" or " much improved".

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.

Last Observation Carried Forward

Arm/Group Title Sertraline Paroxetine
Hide Arm/Group Description:

Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.

At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks.

Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.

At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks.

Overall Number of Participants Analyzed 127 127
Measure Type: Number
Unit of Measure: Percentage of participants
83.5 85.0
3.Secondary Outcome
Title Mean Change From Baseline in Panic Attack at the End of Treatment Phase
Hide Description Panic attacks were defined as having four or more of the following Diagnostic and Statistical Manual of Mental Disorders symptoms. Palpitations or increased heart rate, Sweating, Trembling or shaking, Shortness of breath or smothering sensations, Choking, Chest pain or discomfort, Nausea or upset stomach, Dizziness, unsteady feelings or faintness, Feeling unlike yourself, or detached from a situation and/or like things happening around you are strange and unreal, Fear of going crazy or doing something uncontrolled, Fear of dying, Abnormal sense, Hot flashes or chills.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.

Last Observation Carried Forward

Arm/Group Title Sertraline Paroxetine
Hide Arm/Group Description:

Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.

At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks.

Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.

At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks.

Overall Number of Participants Analyzed 127 127
Mean (Standard Deviation)
Unit of Measure: panic attacks per week
-4.07  (6.12) -4.59  (7.52)
4.Secondary Outcome
Title Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase
Hide Description

The Hamilton Anxiety Rating Scale provided a 5-point intensity rating (0=None to 4=Very severe) of anxiety symptoms in 14 items.

The increasing values are considered worse outcome. The total possible score is ranged from 0 to 52.

Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.

Last Observation Carried Forward

Arm/Group Title Sertraline Paroxetine
Hide Arm/Group Description:

Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.

At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks.

Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.

At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks.

Overall Number of Participants Analyzed 127 127
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-11.35  (10.45) -10.36  (8.27)
5.Secondary Outcome
Title Number of Participants With Summary of Adverse Events in Treatment Phase
Hide Description Number of sparticipants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants were counted only once per treatment in each row.
Time Frame 1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug.
Arm/Group Title Sertraline Paroxetine
Hide Arm/Group Description:

Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.

At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks.

Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.

At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks.

Overall Number of Participants Analyzed 157 162
Measure Type: Number
Unit of Measure: Participants
Subjects with adverse events 127 134
Subjects with serious adverse events 1 1
Subjects with severe adverse events 3 14
Subjects discontinued due to adverse events 14 23
Dose reduced or temporary discontinuation 13 14
6.Secondary Outcome
Title Summary of Adverse Events in Tapering Phase
Hide Description Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects were counted only once per treatment in each row.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug.
Arm/Group Title Sertraline Paroxetine
Hide Arm/Group Description:

Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.

At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks.

Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.

At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks.

Overall Number of Participants Analyzed 132 122
Measure Type: Number
Unit of Measure: Participants
Subjects with adverse events 73 87
Subjects with serious adverse events 1 0
Subjects with severe adverse events 11 16
Subjects discontinued due to adverse events 1 4
Dose reduced or temporary discontinuation 0 0
7.Secondary Outcome
Title Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase
Hide Description The percentage of participants divided was calcurated as follows: Devide the number of participants who had experienced new symptoms in Week 16, regardless of causal relationship with the study drug, or worsening of the severity in Week 16 compared with Week 12, by total number of participants in each treatment group.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Completer Set : Subset of patients in the EES who had a PAS rating at Week 16.
Arm/Group Title Sertraline Paroxetine
Hide Arm/Group Description:

Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.

At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks.

Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.

At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks.

Overall Number of Participants Analyzed 124 118
Measure Type: Number
Unit of Measure: Percentage of participants
59.7 76.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline, Paroxetine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0062
Comments The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05 (two-sided).
Method Fisher Exact
Comments [Not Specified]
Time Frame 16 weeks
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Sertraline Paroxetine
Hide Arm/Group Description

Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.

At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks.

Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.

At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks.

All-Cause Mortality
Sertraline Paroxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sertraline Paroxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   2/157 (1.27%)   1/162 (0.62%) 
Infections and infestations     
Enteritis infectious  1  0/157 (0.00%)  1/162 (0.62%) 
Psychiatric disorders     
Suicidal ideation  1  1/157 (0.64%)  0/162 (0.00%) 
Skin and subcutaneous tissue disorders     
Erythema multiforme  1  1/157 (0.64%)  0/162 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Sertraline Paroxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   132/157 (84.08%)   137/162 (84.57%) 
Cardiac disorders     
Palpitations  1  7/157 (4.46%)  10/162 (6.17%) 
Tachycardia  1  5/157 (3.18%)  13/162 (8.02%) 
Ear and labyrinth disorders     
Tinnitus  1  1/157 (0.64%)  10/162 (6.17%) 
Vertigo  1  7/157 (4.46%)  21/162 (12.96%) 
Gastrointestinal disorders     
Abdominal discomfort  1  7/157 (4.46%)  6/162 (3.70%) 
Abdominal pain upper  1  11/157 (7.01%)  8/162 (4.94%) 
Constipation  1  7/157 (4.46%)  23/162 (14.20%) 
Diarrhoea  1  37/157 (23.57%)  29/162 (17.90%) 
Dry mouth  1  15/157 (9.55%)  10/162 (6.17%) 
Nausea  1  43/157 (27.39%)  66/162 (40.74%) 
Stomatitis  1  5/157 (3.18%)  1/162 (0.62%) 
Vomiting  1  7/157 (4.46%)  13/162 (8.02%) 
General disorders     
Asthenia  1  7/157 (4.46%)  15/162 (9.26%) 
Chills  1  9/157 (5.73%)  16/162 (9.88%) 
Fatigue  1  12/157 (7.64%)  17/162 (10.49%) 
Feeling jittery  1  6/157 (3.82%)  15/162 (9.26%) 
Irritability  1  8/157 (5.10%)  22/162 (13.58%) 
Malaise  1  12/157 (7.64%)  17/162 (10.49%) 
Thirst  1  6/157 (3.82%)  7/162 (4.32%) 
Infections and infestations     
Nasopharyngitis  1  37/157 (23.57%)  35/162 (21.60%) 
Metabolism and nutrition disorders     
Decreased appetite  1  6/157 (3.82%)  9/162 (5.56%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal stiffness  1  7/157 (4.46%)  1/162 (0.62%) 
Myalgia  1  7/157 (4.46%)  16/162 (9.88%) 
Nervous system disorders     
Disturbance in attention  1  9/157 (5.73%)  19/162 (11.73%) 
Dizziness  1  42/157 (26.75%)  61/162 (37.65%) 
Headache  1  20/157 (12.74%)  47/162 (29.01%) 
Hypoaesthesia  1  5/157 (3.18%)  9/162 (5.56%) 
Myoclonus  1  4/157 (2.55%)  6/162 (3.70%) 
Paraesthesia  1  4/157 (2.55%)  11/162 (6.79%) 
Somnolence  1  34/157 (21.66%)  62/162 (38.27%) 
Tremor  1  6/157 (3.82%)  19/162 (11.73%) 
Psychiatric disorders     
Abnormal dreams  1  4/157 (2.55%)  11/162 (6.79%) 
Anxiety  1  16/157 (10.19%)  24/162 (14.81%) 
Depression  1  9/157 (5.73%)  14/162 (8.64%) 
Insomnia  1  19/157 (12.10%)  30/162 (18.52%) 
Mood altered  1  8/157 (5.10%)  15/162 (9.26%) 
Panic disorder  1  2/157 (1.27%)  6/162 (3.70%) 
Respiratory, thoracic and mediastinal disorders     
Yawning  1  3/157 (1.91%)  8/162 (4.94%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  16/157 (10.19%)  18/162 (11.11%) 
Urticaria  1  5/157 (3.18%)  2/162 (1.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
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: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00677352     History of Changes
Other Study ID Numbers: A0501088
First Submitted: May 9, 2008
First Posted: May 14, 2008
Results First Submitted: January 19, 2011
Results First Posted: May 6, 2011
Last Update Posted: May 20, 2011