ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

• 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: UCB S.A. - Pharma Sector
• 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

Participant Flow

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)
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

Baseline Characteristics

Arm/Group Title		Continuous Treatment (CT)	On Demand Treatment (ODT)	Total Title
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
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%

Outcome Measures

1. Primary Outcome

Title	Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period
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

Outcome Measure Data

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)
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)

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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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)

Adverse Events

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)
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%)
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%)
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: UCB
• Organization: Cares
• Phone: +1844 599 ext 2273
• EMail: UCBCares@ucb.com

• 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