Trial Outcomes & Findings for A Study to Assess Intranasal Repeat Dose Effect of Levocabastine in the Subjects With Allergic Rhinitis (NCT NCT01949051)
NCT ID: NCT01949051
Last Updated: 2017-06-06
Results Overview
The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch, and sneezing, each scored on 0-3 scale \[0=none, 1=mild, 2=moderate, 3=severe\]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
Day 8 of each treatment period (up to 13 Weeks)
Results posted on
2017-06-06
Participant Flow
Participants who met the eligibility criteria at Screening were randomized to 1 of 6 treatment sequences. The treatment phase was comprised of three 7-day treatment periods, each separated by a 14- to 20-day washout period.
Participant milestones
| Measure |
Sequence 1: Levo 200 µg, Levo 400µg, Placebo
Participants received levocabastine (Levo) 200 micrograms (µg), Levo 400µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg once daily (OD) in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg twice daily (BID) in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
|
Sequence 2: Levo 400µg, Placebo and Levo 200µg
Participants received Levo 400µg, placebo and Levo 200µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
|
Sequence 3: Placebo, Levo 200µg and Levo 400µg
Participants received placebo, Levo 200µg and Levo 400µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
|
Sequence 4: Levo 200µg, Placebo, and Levo 400µg
Participants received Levo 200µg, placebo, and Levo 400µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
|
Sequence 5: Levo 400µg, Levo 200µg and Placebo
Participants received Levo 400µg, Levo 200µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
|
Sequence 6: Placebo, Levo 400µg and Levo 200µg
Participants received placebo, Levo 400µg and Levo 200µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1 (7 Days)
STARTED
|
13
|
13
|
13
|
13
|
13
|
13
|
|
Treatment Period 1 (7 Days)
COMPLETED
|
11
|
13
|
13
|
12
|
13
|
13
|
|
Treatment Period 1 (7 Days)
NOT COMPLETED
|
2
|
0
|
0
|
1
|
0
|
0
|
|
Washout Period 1 (14 to 20 Days)
STARTED
|
11
|
13
|
13
|
12
|
13
|
13
|
|
Washout Period 1 (14 to 20 Days)
COMPLETED
|
11
|
13
|
13
|
12
|
13
|
13
|
|
Washout Period 1 (14 to 20 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (7 Days)
STARTED
|
11
|
13
|
13
|
12
|
13
|
13
|
|
Treatment Period 2 (7 Days)
COMPLETED
|
11
|
12
|
12
|
12
|
13
|
12
|
|
Treatment Period 2 (7 Days)
NOT COMPLETED
|
0
|
1
|
1
|
0
|
0
|
1
|
|
Washout Period 2 (14 to 20 Days)
STARTED
|
11
|
12
|
12
|
12
|
13
|
12
|
|
Washout Period 2 (14 to 20 Days)
COMPLETED
|
11
|
12
|
12
|
12
|
13
|
12
|
|
Washout Period 2 (14 to 20 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (7 Days)
STARTED
|
11
|
12
|
12
|
12
|
13
|
12
|
|
Treatment Period 3 (7 Days)
COMPLETED
|
11
|
12
|
12
|
12
|
13
|
12
|
|
Treatment Period 3 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: Levo 200 µg, Levo 400µg, Placebo
Participants received levocabastine (Levo) 200 micrograms (µg), Levo 400µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg once daily (OD) in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg twice daily (BID) in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
|
Sequence 2: Levo 400µg, Placebo and Levo 200µg
Participants received Levo 400µg, placebo and Levo 200µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
|
Sequence 3: Placebo, Levo 200µg and Levo 400µg
Participants received placebo, Levo 200µg and Levo 400µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
|
Sequence 4: Levo 200µg, Placebo, and Levo 400µg
Participants received Levo 200µg, placebo, and Levo 400µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
|
Sequence 5: Levo 400µg, Levo 200µg and Placebo
Participants received Levo 400µg, Levo 200µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
|
Sequence 6: Placebo, Levo 400µg and Levo 200µg
Participants received placebo, Levo 400µg and Levo 200µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1 (7 Days)
Protocol Violation
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 1 (7 Days)
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (7 Days)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 2 (7 Days)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (7 Days)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Assess Intranasal Repeat Dose Effect of Levocabastine in the Subjects With Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
Placebo/Levocabastine
n=78 Participants
Participants received placebo/ Levo at a dose of 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) into each nostril or 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days each, in a crossover design. Treatment was given in one of six sequences in Periods 1, 2, and 3, (14 to 20 day washout period between treatments): ABC, BCA, CAB, ACB, BAC, CBA (A, Levo 200µg; B, Levo 400µg: C, Placebo). On Day 8 of each treatment period (approximately 12 hours post dosing for treatment A and 24 hours post dosing for treatment B and C), participants entered the environmental exposure chamber (EEC) for a 4-hour period, and the assessments were conducted 12-24 hours post-dose. All participants attended a follow-up visit within 7 to 14 day after their final dose, and the overall duration for participation in the study (screening to follow-up) was 13 weeks.
|
|---|---|
|
Age, Continuous
|
42.3 Years
STANDARD_DEVIATION 11.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Mixed Race
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 8 of each treatment period (up to 13 Weeks)Population: Per Protocol Population: all participants in the Intent-to-Treat Population (defined as all participants who were randomized and received \>= 1 dose of study medication) and not identified as full protocol deviators with respect to criteria that were considered to impact the primary efficacy analysis. Only those participants contributing data at the
The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch, and sneezing, each scored on 0-3 scale \[0=none, 1=mild, 2=moderate, 3=severe\]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.
Outcome measures
| Measure |
Placebo
n=71 Participants
Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
|
Levocabastine 200µg OD
n=71 Participants
Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
|
Levocabastine 400µg BID
n=71 Participants
Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
|
|---|---|---|---|
|
Weighted Mean of the Total Nasal Symptom Score (TNSS) (0-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 8
|
5.190 Scores on a scale
Interval 4.62 to 5.76
|
4.071 Scores on a scale
Interval 3.502 to 4.641
|
3.840 Scores on a scale
Interval 3.271 to 4.41
|
SECONDARY outcome
Timeframe: Day 8 of each treatment period (up to 13 Weeks)Population: ITT Population. Only those participants contributing data at the indicated time points were analyzed.
TNSS contains symtom scores for the four individual components (nasal congestion \[NACG\], rhinorrhea \[RHSCR\], nasal itching \[NAITS\] and sneezing \[SNZS\]), each scored on a 0 - 3 scale \[0=none, 1=mild, 2=moderate, 3=severe\]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen is administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. The participants recorded their symptom scores on an e-diary. The mean score for each participant was calculated using the available diary data from the assessment periods, taking the average of non-missing data during the period. Weighted mean of the individual symptoms of theTNSS were calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
|
Levocabastine 200µg OD
n=73 Participants
Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
|
Levocabastine 400µg BID
n=73 Participants
Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
|
|---|---|---|---|
|
Weighted Mean of the Symptom Scores for the Four Individual Components of the Total Nasal Symptom Score (TNSS) (Nasal Congestion, Rhinorrhea, Nasal Itching and Sneezing) (0-4) Hours Post Start of the Allergen Chamber Challenge on Day 8
NACG
|
1.483 Scores on a scale
Interval 1.322 to 1.643
|
1.217 Scores on a scale
Interval 1.056 to 1.378
|
1.226 Scores on a scale
Interval 1.065 to 1.387
|
|
Weighted Mean of the Symptom Scores for the Four Individual Components of the Total Nasal Symptom Score (TNSS) (Nasal Congestion, Rhinorrhea, Nasal Itching and Sneezing) (0-4) Hours Post Start of the Allergen Chamber Challenge on Day 8
RHSCR
|
1.403 Scores on a scale
Interval 1.232 to 1.574
|
1.035 Scores on a scale
Interval 0.863 to 1.206
|
1.004 Scores on a scale
Interval 0.833 to 1.176
|
|
Weighted Mean of the Symptom Scores for the Four Individual Components of the Total Nasal Symptom Score (TNSS) (Nasal Congestion, Rhinorrhea, Nasal Itching and Sneezing) (0-4) Hours Post Start of the Allergen Chamber Challenge on Day 8
NAITS
|
1.257 Scores on a scale
Interval 1.092 to 1.423
|
1.099 Scores on a scale
Interval 0.932 to 1.265
|
1.040 Scores on a scale
Interval 0.874 to 1.207
|
|
Weighted Mean of the Symptom Scores for the Four Individual Components of the Total Nasal Symptom Score (TNSS) (Nasal Congestion, Rhinorrhea, Nasal Itching and Sneezing) (0-4) Hours Post Start of the Allergen Chamber Challenge on Day 8
SNZS
|
1.018 Scores on a scale
Interval 0.857 to 1.178
|
0.647 Scores on a scale
Interval 0.486 to 0.808
|
0.529 Scores on a scale
Interval 0.368 to 0.69
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Levocabastine 200µg OD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Levocabastine 400µg BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=75 participants at risk
Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
|
Levocabastine 200µg OD
n=76 participants at risk
Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
|
Levocabastine 400µg BID
n=74 participants at risk
Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
1.3%
1/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
0.00%
0/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
4.1%
3/74 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
|
Nervous system disorders
Somnolence
|
1.3%
1/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
0.00%
0/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
1.4%
1/74 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
0.00%
0/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
1.4%
1/74 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
|
General disorders
Fatigue
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
1.3%
1/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
0.00%
0/74 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
|
Investigations
Blood pressure increased
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
1.3%
1/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
0.00%
0/74 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
1.3%
1/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
0.00%
0/74 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/75 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
1.3%
1/76 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
0.00%
0/74 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the follow-up contact (up to 13 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all randomized participants who received at least one dose of investigational product , according to the actual treatment received.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER