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Trial record 1 of 1 for:    NCT00160680
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ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

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: NCT00160680
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : January 22, 2019
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB S.A. - Pharma Sector )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rhinitis, Allergic, Perennial
Intervention Drug: Levocetirizine
Enrollment 62
Recruitment Details The study started to enroll patients in March 2005 and concluded in June 2006.
Pre-assignment Details Participant Flow refers to the Randomized Set.
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT)
Hide Arm/Group Description 5 mg of Levocetirizine (LCTZ) was taken orally once a day. 5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Period Title: Overall Study
Started 31 31
Completed 22 18
Not Completed 9 13
Reason Not Completed
Adverse Event             0             1
Lack of Efficacy             2             1
Lost to Follow-up             3             2
Withdrawal by Subject             4             9
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT) Total Title
Hide Arm/Group Description 5 mg of Levocetirizine (LCTZ) was taken orally once a day. 5 mg of Levocetirizine (LCTZ) was taken whenever needed. [Not Specified]
Overall Number of Baseline Participants 31 31 62
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Intention-to-Treat Population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
  96.8%
30
  96.8%
60
  96.8%
>=65 years
1
   3.2%
1
   3.2%
2
   3.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 31 participants 62 participants
34.74  (12.33) 35.20  (10.71) 34.97  (11.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
Female
19
  61.3%
24
  77.4%
43
  69.4%
Male
12
  38.7%
7
  22.6%
19
  30.6%
1.Primary Outcome
Title Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period
Hide Description The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Time Frame During the treatment period until week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with a valid mean weekly T4SS during the treatment period were included in the analysis.
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT)
Hide Arm/Group Description:
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Overall Number of Participants Analyzed 29 29
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.89  (0.43) 3.15  (0.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Treatment (CT), On Demand Treatment (ODT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.667
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-0.96 to 1.50
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period
Hide Description The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Time Frame During month 1 of the 6 months treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with a valid T4SS at month 1 were included in the analysis.
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT)
Hide Arm/Group Description:
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Overall Number of Participants Analyzed 28 29
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.55  (0.61) 3.83  (0.61)
3.Secondary Outcome
Title Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period
Hide Description The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Time Frame During month 2 of the 6 months treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with a valid T4SS at month 2 were included in the analysis.
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT)
Hide Arm/Group Description:
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Overall Number of Participants Analyzed 27 26
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.04  (0.63) 3.14  (0.63)
4.Secondary Outcome
Title Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period
Hide Description The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Time Frame During month 3 of the 6 months treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with a valid T4SS at month 3 were included in the analysis.
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT)
Hide Arm/Group Description:
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Overall Number of Participants Analyzed 25 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.98  (0.50) 2.58  (0.51)
5.Secondary Outcome
Title Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period
Hide Description The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Time Frame During month 4 of the 6 months treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with a valid T4SS at month 4 were included in the analysis.
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT)
Hide Arm/Group Description:
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Overall Number of Participants Analyzed 26 20
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.47  (0.47) 2.67  (0.50)
6.Secondary Outcome
Title Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period
Hide Description The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Time Frame During month 5 of the 6 months treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with a valid T4SS at month 5 were included in the analysis.
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT)
Hide Arm/Group Description:
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Overall Number of Participants Analyzed 22 18
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.74  (0.45) 3.31  (0.48)
7.Secondary Outcome
Title Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period
Hide Description The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Time Frame During month 6 of the 6 months treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with a valid T4SS at month 6 were included in the analysis.
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT)
Hide Arm/Group Description:
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Overall Number of Participants Analyzed 19 19
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.19  (0.57) 3.64  (0.59)
8.Secondary Outcome
Title Mean Weekly Individual Symptoms Scores During the Treatment Period
Hide Description

Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.

The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.

Time Frame During the treatment period until week 24
Hide Outcome Measure Data
Hide Analysis Population Description
31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean weekly individual symptoms scores were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT)
Hide Arm/Group Description:
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Overall Number of Participants Analyzed 31 31
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Sneezing Score Number Analyzed 30 participants 30 participants
0.82  (0.11) 0.94  (0.12)
Rhinorrhea Score Number Analyzed 30 participants 30 participants
0.80  (0.12) 0.80  (0.12)
Nasal Pruritus Score Number Analyzed 29 participants 30 participants
0.71  (0.12) 0.74  (0.12)
Ocular Pruritus Score Number Analyzed 29 participants 29 participants
0.55  (0.10) 0.68  (0.10)
Nasal Congestion Score Number Analyzed 26 participants 28 participants
0.87  (0.14) 1.08  (0.14)
9.Secondary Outcome
Title Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period
Hide Description

Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.

The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.

Time Frame During month 1 of the 6 months treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 1 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT)
Hide Arm/Group Description:
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Overall Number of Participants Analyzed 31 31
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Sneezing Score Number Analyzed 29 participants 30 participants
1.31  (0.15) 1.12  (0.15)
Rhinorrhea Score Number Analyzed 29 participants 30 participants
1.33  (0.16) 0.93  (0.16)
Nasal Pruritus Score Number Analyzed 28 participants 30 participants
1.06  (0.17) 0.97  (0.16)
Ocular Pruritus Score Number Analyzed 28 participants 29 participants
0.90  (0.17) 0.86  (0.17)
Nasal Congestion Score Number Analyzed 24 participants 28 participants
1.25  (0.19) 1.25  (0.18)
10.Secondary Outcome
Title Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period
Hide Description

Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.

The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.

Time Frame During month 2 of the 6 months treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 2 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT)
Hide Arm/Group Description:
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Overall Number of Participants Analyzed 31 31
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Sneezing Score Number Analyzed 27 participants 27 participants
1.20  (0.16) 0.87  (0.16)
Rhinorrhea Score Number Analyzed 27 participants 26 participants
1.14  (0.17) 0.80  (0.17)
Nasal Pruritus Score Number Analyzed 27 participants 26 participants
0.98  (0.16) 0.75  (0.16)
Ocular Pruritus Score Number Analyzed 27 participants 26 participants
0.77  (0.17) 0.77  (0.17)
Nasal Congestion Score Number Analyzed 24 participants 25 participants
1.03  (0.19) 1.04  (0.18)
11.Secondary Outcome
Title Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period
Hide Description

Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.

The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.

Time Frame During month 3 of the 6 months treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 3 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT)
Hide Arm/Group Description:
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Overall Number of Participants Analyzed 31 31
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Sneezing Score Number Analyzed 25 participants 24 participants
0.82  (0.14) 0.81  (0.15)
Rhinorrhea Score Number Analyzed 25 participants 24 participants
0.84  (0.14) 0.66  (0.14)
Nasal Pruritus Score Number Analyzed 25 participants 24 participants
0.74  (0.13) 0.53  (0.13)
Ocular Pruritus Score Number Analyzed 25 participants 24 participants
0.61  (0.13) 0.60  (0.14)
Nasal Congestion Score Number Analyzed 24 participants 23 participants
0.87  (0.16) 0.91  (0.16)
12.Secondary Outcome
Title Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period
Hide Description

Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.

The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.

Time Frame During month 4 of the 6 months treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 4 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT)
Hide Arm/Group Description:
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Overall Number of Participants Analyzed 31 31
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Sneezing Score Number Analyzed 26 participants 20 participants
0.78  (0.14) 0.85  (0.15)
Rhinorrhea Score Number Analyzed 26 participants 20 participants
0.69  (0.14) 0.72  (0.14)
Nasal Pruritus Score Number Analyzed 26 participants 20 participants
0.60  (0.13) 0.59  (0.14)
Ocular Pruritus Score Number Analyzed 26 participants 20 participants
0.44  (0.11) 0.53  (0.12)
Nasal Congestion Score Number Analyzed 25 participants 19 participants
0.75  (0.15) 1.07  (0.16)
13.Secondary Outcome
Title Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period
Hide Description

Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.

The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.

Time Frame During month 5 of the 6 months treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 5 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT)
Hide Arm/Group Description:
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Overall Number of Participants Analyzed 31 31
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Sneezing Score Number Analyzed 22 participants 18 participants
0.51  (0.12) 1.00  (0.13)
Rhinorrhea Score Number Analyzed 22 participants 18 participants
0.51  (0.14) 0.93  (0.15)
Nasal Pruritus Score Number Analyzed 22 participants 18 participants
0.44  (0.12) 0.77  (0.13)
Ocular Pruritus Score Number Analyzed 22 participants 18 participants
0.27  (0.10) 0.63  (0.11)
Nasal Congestion Score Number Analyzed 21 participants 17 participants
0.63  (0.15) 1.08  (0.16)
14.Secondary Outcome
Title Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period
Hide Description

Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.

The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.

Time Frame During month 6 of the 6 months treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
31 patients were included in the ITT-Set for each treatment group. Only patients with valid mean monthly individual symptoms scores at month 6 were included in the analysis of this outcome measure. Number of patients analyzed are given for each individual symptoms score.
Arm/Group Title Continuous Treatment (CT) On Demand Treatment (ODT)
Hide Arm/Group Description:
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Overall Number of Participants Analyzed 31 31
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Sneezing Score Number Analyzed 19 participants 19 participants
0.61  (0.15) 1.11  (0.16)
Rhinorrhea Score Number Analyzed 19 participants 19 participants
0.57  (0.15) 1.00  (0.16)
Nasal Pruritus Score Number Analyzed 19 participants 19 participants
0.59  (0.15) 0.84  (0.16)
Ocular Pruritus Score Number Analyzed 19 participants 19 participants
0.36  (0.14) 0.69  (0.14)
Nasal Congestion Score Number Analyzed 18 participants 18 participants
0.82  (0.17) 1.15  (0.18)
Time Frame Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).
Adverse Event Reporting Description Adverse Events refer to the Safety Population consisting of all randomized subjects. One subject took the treatment under on demand regimen instead of continuous regimen. For the safety analyses, this subject was analyzed according to actual regimen received. Therefore, the Safety Population consisted of 62 subjects: 30 under the continuous regimen and 32 under the on demand regimen.
 
Arm/Group Title Continuous Treatment (SS) On Demand Treatment (SS)
Hide Arm/Group Description 5 mg of Levocetirizine (LCTZ) was taken orally once a day. 5 mg of Levocetirizine (LCTZ) was taken whenever needed.
All-Cause Mortality
Continuous Treatment (SS) On Demand Treatment (SS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/32 (0.00%) 
Hide Serious Adverse Events
Continuous Treatment (SS) On Demand Treatment (SS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/32 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Continuous Treatment (SS) On Demand Treatment (SS)
Affected / at Risk (%) Affected / at Risk (%)
Total   4/30 (13.33%)   10/32 (31.25%) 
Ear and labyrinth disorders     
Eustachian tube obstruction * 1  0/30 (0.00%)  1/32 (3.13%) 
Vertigo * 1  1/30 (3.33%)  0/32 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper * 1  0/30 (0.00%)  1/32 (3.13%) 
General disorders     
Pain * 1  0/30 (0.00%)  1/32 (3.13%) 
Infections and infestations     
Ear infection * 1  0/30 (0.00%)  1/32 (3.13%) 
Influenza * 1  1/30 (3.33%)  2/32 (6.25%) 
Nasopharyngitis * 1  0/30 (0.00%)  2/32 (6.25%) 
Pharyngitis * 1  0/30 (0.00%)  1/32 (3.13%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/30 (0.00%)  1/32 (3.13%) 
Nervous system disorders     
Headache * 1  0/30 (0.00%)  2/32 (6.25%) 
Neuralgia * 1  0/30 (0.00%)  1/32 (3.13%) 
Somnolence * 1  1/30 (3.33%)  3/32 (9.38%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  0/30 (0.00%)  1/32 (3.13%) 
Epistaxis * 1  1/30 (3.33%)  2/32 (6.25%) 
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB S.A. - Pharma Sector )
ClinicalTrials.gov Identifier: NCT00160680    
Other Study ID Numbers: A00392
2004-003858-26 ( EudraCT Number )
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: October 10, 2017
Results First Posted: January 22, 2019
Last Update Posted: January 22, 2019