Trial Outcomes & Findings for An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder (NCT NCT00579982)
NCT ID: NCT00579982
Last Updated: 2016-12-16
Results Overview
The CSS is the sum of items 9 (values: 1=Extremely difficult - 7=Extremely easy), 10 (same set of values as for 9), and 11 (1=Extremely inconvenient - 7=Extremely convenient). The sum has 3 subtracted from it, is divided by 18, and then multiplied by 100; the range is 0-100. Change from baseline=end of study CSS minus baseline score.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
97 participants
Primary outcome timeframe
Baseline, End of Study (Week 3) or Early Withdrawal
Results posted on
2016-12-16
Participant Flow
Participant milestones
| Measure |
Lamotrigine
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Overall Study
STARTED
|
97
|
|
Overall Study
COMPLETED
|
89
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Lamotrigine
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Protocol Violation
|
4
|
Baseline Characteristics
An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder
Baseline characteristics by cohort
| Measure |
Lamotrigine
n=97 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 12.07 • n=5 Participants
|
|
Gender
Female
|
83 Participants
n=5 Participants
|
|
Gender
Male
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
94 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, End of Study (Week 3) or Early WithdrawalPopulation: Intent to Treat (ITT). Ninety-eight participants were enrolled in the study, but one withdrew prior to receiving lamotrigine ODT treatment. All efficacy and safety analyses are based on the Intent to Treat population, which includes the 97 patients who received at least one dose of ODT treatment.
The CSS is the sum of items 9 (values: 1=Extremely difficult - 7=Extremely easy), 10 (same set of values as for 9), and 11 (1=Extremely inconvenient - 7=Extremely convenient). The sum has 3 subtracted from it, is divided by 18, and then multiplied by 100; the range is 0-100. Change from baseline=end of study CSS minus baseline score.
Outcome measures
| Measure |
Lamotrigine
n=97 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Mean Change From Baseline in the Convenience Subscale Score (CSS) Derived From the Treatment Satisfaction Questionnaire for Medication (TSQM v 1.4) Using Items 9 (Ease of Use), 10 (Ease of Planning to Use), and 11 (Convenience) at Week 3.
|
23.3 Points on a subscale
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: Baseline, End of Study (Week 3) or Early WithdrawalPopulation: ITT
The Global Satisfaction Subscale Score is the sum of item 12 (values: 1=Not at all confident - 5=Extremely confident), item 13 (values: 1=Not at all certain - 5=Extremely certain), and item 14 (Extremely dissatisfied - 7=Extremely satisfied). The sum has 3 subtracted from it, is divided by 14, and then multiplied by 100; thus, the range is 0-100.
Outcome measures
| Measure |
Lamotrigine
n=97 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Mean Change From Baseline in the Global Satisfaction Subscale Score, From the TSQM Using Items 12 (Confidence in Medicine), 13 (Certainty That Good Things About Medication Outweigh Bad Things), and 14 (Satisfaction With Medication) at Week 3
|
-0.3 Points on a subscale
Standard Deviation 29.34
|
SECONDARY outcome
Timeframe: Baseline, End of Study (Week 3) or at Early WithdrawalPopulation: ITT
Clinician assessment evaluating how mentally ill the patient is at time of evaluation. The questionnaire is based on a 7-point scale (from1 = Normal to 7 = Among the most extremely ill patients).
Outcome measures
| Measure |
Lamotrigine
n=96 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3
|
0.0 Points on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Baseline, End of Study (Week 3 weeks) or at Early WithdrawalPopulation: ITT
Participant-reported questionnaire consisting of 21 items on a 4 point scale (0 to 3, with 3 indicating most severely ill), with the score being the sum of the items. The change from baseline is the end of study score minus the baseline score; larger values indicate more depression with the ODT formulation relative to the IR formulation.
Outcome measures
| Measure |
Lamotrigine
n=97 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Mean Change From Baseline in the Beck Depression Inventory (BDI-II) Score at Week 3
|
-1.7 Points on a scale
Standard Deviation 9.52
|
SECONDARY outcome
Timeframe: End of Study (Week 3) or Early WithdrawalPopulation: ITT
The Organoleptic Questionnaire (9 items) was used to assess the participants' satisfaction with the physical characteristics of the ODT formulation e.g. rate of dissolution, flavor. Question number 1 on organoleptic questionnaire: Did the tablets dissolve instantly (yes or no)?
Outcome measures
| Measure |
Lamotrigine
n=97 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Number of Participants Answering the Question "Did the Tablets Dissolve Instantly (Yes or no)?" at Week 3
Yes
|
60 Number of participants
|
|
Number of Participants Answering the Question "Did the Tablets Dissolve Instantly (Yes or no)?" at Week 3
No
|
37 Number of participants
|
SECONDARY outcome
Timeframe: Baseline, End of Study (Week 3) or Early WithdrawalPopulation: ITT
Question number 2 on organoleptic questionnaire: How satisfied or dissatisfied were you with the time it took the tablet to dissolve? \[from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)\]
Outcome measures
| Measure |
Lamotrigine
n=97 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Number of Participants Answering the Question "How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve" at Week 3
Extremely satisfied
|
29 Number of participants
|
|
Number of Participants Answering the Question "How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve" at Week 3
Extremely dissatisfied
|
3 Number of participants
|
|
Number of Participants Answering the Question "How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve" at Week 3
Very dissatisfied
|
10 Number of participants
|
|
Number of Participants Answering the Question "How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve" at Week 3
Satisfied
|
37 Number of participants
|
|
Number of Participants Answering the Question "How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve" at Week 3
Very satisfied
|
18 Number of participants
|
SECONDARY outcome
Timeframe: End of Study (Week 3) or Early WithdrawalPopulation: ITT
Question number 3 on organoleptic questionnaire: How did the dissolved tablet feel in your mouth? \[from a rating of 1 (Extremely gritty) to 5 (Extremely smooth)\]
Outcome measures
| Measure |
Lamotrigine
n=97 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Number of Participants Answering the Question "How Did the Dissolved Tablet Feel in Your Mouth?" at Week 3
Extremely gritty
|
0 Number of participants
|
|
Number of Participants Answering the Question "How Did the Dissolved Tablet Feel in Your Mouth?" at Week 3
Very gritty
|
19 Number of participants
|
|
Number of Participants Answering the Question "How Did the Dissolved Tablet Feel in Your Mouth?" at Week 3
Smooth
|
45 Number of participants
|
|
Number of Participants Answering the Question "How Did the Dissolved Tablet Feel in Your Mouth?" at Week 3
Very smooth
|
19 Number of participants
|
|
Number of Participants Answering the Question "How Did the Dissolved Tablet Feel in Your Mouth?" at Week 3
Extremely smooth
|
14 Number of participants
|
SECONDARY outcome
Timeframe: End of Study (Week 3) or Early WithdrawalPopulation: ITT
Question number 4 on organoleptic questionnaire: How satisfied were you with the flavor of the tablet? \[from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)\]
Outcome measures
| Measure |
Lamotrigine
n=97 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Number of Participants Answering the Question "How Satisfied Were You With the Flavor of the Tablet?" at Week 3
Extremely dissatisfied
|
5 Number of participants
|
|
Number of Participants Answering the Question "How Satisfied Were You With the Flavor of the Tablet?" at Week 3
Very dissatisfied
|
10 Number of participants
|
|
Number of Participants Answering the Question "How Satisfied Were You With the Flavor of the Tablet?" at Week 3
Satisfied
|
26 Number of participants
|
|
Number of Participants Answering the Question "How Satisfied Were You With the Flavor of the Tablet?" at Week 3
Very satisfied
|
23 Number of participants
|
|
Number of Participants Answering the Question "How Satisfied Were You With the Flavor of the Tablet?" at Week 3
Extremely satisfied
|
33 Number of participants
|
SECONDARY outcome
Timeframe: End of Study (Week 3) or Early WithdrawalPopulation: ITT
Organoleptic Questionnaire, question 5: How would you rate the strength of the flavor of the tablet? \[from 1 a rating of (Extremely bothersome) to 5 (Extremely pleasant)\]
Outcome measures
| Measure |
Lamotrigine
n=97 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Number of Participants Answering the Question "How Would You Rate the Strength of the Flavor of the Tablet"? at Week 3
Extremely bothersome
|
2 Number of participants
|
|
Number of Participants Answering the Question "How Would You Rate the Strength of the Flavor of the Tablet"? at Week 3
Very bothersome
|
14 Number of participants
|
|
Number of Participants Answering the Question "How Would You Rate the Strength of the Flavor of the Tablet"? at Week 3
Pleasant
|
36 Number of participants
|
|
Number of Participants Answering the Question "How Would You Rate the Strength of the Flavor of the Tablet"? at Week 3
Very pleasant
|
22 Number of participants
|
|
Number of Participants Answering the Question "How Would You Rate the Strength of the Flavor of the Tablet"? at Week 3
Extremely pleasant
|
23 Number of participants
|
SECONDARY outcome
Timeframe: End of Study (Week 3) or Early WithdrawalPopulation: ITT
Organoleptic Questionnaire, question 6: How would you rate the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? \[from a rating of 1 (Extremely bothersome) to 6 (Did NOT experience an aftertaste)\]
Outcome measures
| Measure |
Lamotrigine
n=97 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Number of Participants Answering the Question "How Would You Rate the Aftertaste of the Tablet"? at Week 3.
Extremely bothersome
|
4 Number of participants
|
|
Number of Participants Answering the Question "How Would You Rate the Aftertaste of the Tablet"? at Week 3.
Very bothersome
|
20 Number of participants
|
|
Number of Participants Answering the Question "How Would You Rate the Aftertaste of the Tablet"? at Week 3.
Pleasant
|
25 Number of participants
|
|
Number of Participants Answering the Question "How Would You Rate the Aftertaste of the Tablet"? at Week 3.
Very pleasant
|
7 Number of participants
|
|
Number of Participants Answering the Question "How Would You Rate the Aftertaste of the Tablet"? at Week 3.
Extremely pleasant
|
12 Number of participants
|
|
Number of Participants Answering the Question "How Would You Rate the Aftertaste of the Tablet"? at Week 3.
I did NOT experience an aftertaste
|
29 Number of participants
|
SECONDARY outcome
Timeframe: Baseline, End of Study (Week 3) or Early WithdrawalPopulation: ITT
Organoleptic Questionnaire, question 7: How satisfied were you with the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? \[from a rating of 1 (Extremely dissatisfied) to 6 (I did NOT experience an aftertaste)\]
Outcome measures
| Measure |
Lamotrigine
n=97 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Number of Participants Answering the Question "How Satisfied Were You With the Aftertaste of the Tablet"? at Week 3
Extremely dissatisfied
|
3 Number of participants
|
|
Number of Participants Answering the Question "How Satisfied Were You With the Aftertaste of the Tablet"? at Week 3
Very dissatisfied
|
16 Number of participants
|
|
Number of Participants Answering the Question "How Satisfied Were You With the Aftertaste of the Tablet"? at Week 3
Satisfied
|
28 Number of participants
|
|
Number of Participants Answering the Question "How Satisfied Were You With the Aftertaste of the Tablet"? at Week 3
Very satisfied
|
11 Number of participants
|
|
Number of Participants Answering the Question "How Satisfied Were You With the Aftertaste of the Tablet"? at Week 3
Extremely satisfied
|
11 Number of participants
|
|
Number of Participants Answering the Question "How Satisfied Were You With the Aftertaste of the Tablet"? at Week 3
I did NOT experience an aftertaste
|
28 Number of participants
|
SECONDARY outcome
Timeframe: End of Study (Week 3) or at Early WithdrawalPopulation: ITT
Organoleptic Questionnaire, question 8: Compared to standard tablets that need to be swallowed with liquid, how convenient or inconvenient did you find this orally disintegrating tablet? (from a rating of 1 \[Extremely inconvenient\] to 5 \[Extremely convenient\])
Outcome measures
| Measure |
Lamotrigine
n=97 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet"? at Week 3
Extremely inconvenient
|
8 Number of participants
|
|
Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet"? at Week 3
Very inconvenient
|
9 Number of participants
|
|
Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet"? at Week 3
Convenient
|
16 Number of participants
|
|
Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet"? at Week 3
Very convenient
|
17 Number of participants
|
|
Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet"? at Week 3
Extremely convenient
|
47 Number of participants
|
SECONDARY outcome
Timeframe: End of Study (Week 3) or at Early WithdrawalPopulation: ITT
Organoleptic Questionnaire, question 9: Compared to standard tablets that need to be swallowed with liquid, how easy or difficult is it to use this orally disintegrating tablet? \[from a rating of 1 (Extremely difficult) to 5 (Extremely easy)\]
Outcome measures
| Measure |
Lamotrigine
n=97 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet?" at Week 3
Extremely difficult
|
2 Number of participants
|
|
Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet?" at Week 3
Very difficult
|
3 Number of participants
|
|
Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet?" at Week 3
Easy
|
17 Number of participants
|
|
Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet?" at Week 3
Very easy
|
20 Number of participants
|
|
Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet?" at Week 3
Extremely easy
|
55 Number of participants
|
SECONDARY outcome
Timeframe: End of Study (Week 3) or at Early WithdrawalPopulation: ITT
Participant indicated whether preference was for ODT or the standard IR tablet
Outcome measures
| Measure |
Lamotrigine
n=97 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Number of Participants Indicating a Preference for ODT or the Standard IR Tablet at Week 3
Prefer ODT
|
72 Number of participants
|
|
Number of Participants Indicating a Preference for ODT or the Standard IR Tablet at Week 3
Prefer standard IR tablet
|
25 Number of participants
|
SECONDARY outcome
Timeframe: End of Study (Week 3) or at Early WithdrawalPopulation: ITT
Companion/Caregiver indicates whether ODT is more convenient or standard IR tablet is more convenient
Outcome measures
| Measure |
Lamotrigine
n=97 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Number of Companions/Caregivers Indicating Whether ODT or Standard IR Tablet is More Convenient at Week 3
ODT more convenient
|
79 Number of participants
|
|
Number of Companions/Caregivers Indicating Whether ODT or Standard IR Tablet is More Convenient at Week 3
Standard IR tablet more convenient
|
18 Number of participants
|
SECONDARY outcome
Timeframe: End of Study (Week 3) or at Early WithdrawalPopulation: ITT: Only 94 of the 97 subjects in the ITT Population responded to the Tablet Routine Questionnaire.
Tablet Routine Questionnaire (Adherence): Adherence to the treatment was evaluated by asking if the participant would be more likely to take the ODT formulation (yes/no)
Outcome measures
| Measure |
Lamotrigine
n=94 Participants
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Number of Participants Indicating at Week 3 (by Answering Yes/no) That They Would be More Likely to Take the ODT Formulation
Yes
|
84 Number of participants
|
|
Number of Participants Indicating at Week 3 (by Answering Yes/no) That They Would be More Likely to Take the ODT Formulation
No
|
10 Number of participants
|
Adverse Events
Lamotrigine
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lamotrigine
n=97 participants at risk
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/97
|
Other adverse events
| Measure |
Lamotrigine
n=97 participants at risk
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation \[SD\]) ODT dose was 261.3 (118.9) mg/day.
|
|---|---|
|
Psychiatric disorders
Anxiety
|
3.1%
3/97
|
|
Psychiatric disorders
Depression
|
3.1%
3/97
|
|
Psychiatric disorders
Hypomania
|
3.1%
3/97
|
|
Psychiatric disorders
Depressed mood
|
1.0%
1/97
|
|
Psychiatric disorders
Insomnia
|
1.0%
1/97
|
|
Psychiatric disorders
Restlessness
|
1.0%
1/97
|
|
Psychiatric disorders
Suicidal ideation
|
1.0%
1/97
|
|
Nervous system disorders
Headache
|
5.2%
5/97
|
|
Nervous system disorders
Dizziness
|
1.0%
1/97
|
|
Gastrointestinal disorders
Nausea
|
2.1%
2/97
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
1/97
|
|
Gastrointestinal disorders
Gastrooeophageal reflux disease
|
1.0%
1/97
|
|
Gastrointestinal disorders
Glossodynia
|
1.0%
1/97
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/97
|
|
Infections and infestations
Bronchitis
|
1.0%
1/97
|
|
Infections and infestations
Influenza
|
1.0%
1/97
|
|
Infections and infestations
Nasopharyngitis
|
1.0%
1/97
|
|
Infections and infestations
Pneumonia
|
1.0%
1/97
|
|
Infections and infestations
Upper respiratory infection
|
1.0%
1/97
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/97
|
|
General disorders
Chest pain
|
1.0%
1/97
|
|
General disorders
Influenza-like illness
|
1.0%
1/97
|
|
General disorders
Irritability
|
1.0%
1/97
|
|
General disorders
Pain
|
1.0%
1/97
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/97
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.0%
1/97
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
1/97
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.0%
1/97
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
1.0%
1/97
|
|
Eye disorders
Vision blurred
|
1.0%
1/97
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
1.0%
1/97
|
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