Trial Outcomes & Findings for Oral DS107 in Moderate to Severe Atopic Dermatitis (NCT NCT02211417)
NCT ID: NCT02211417
Last Updated: 2022-10-07
Results Overview
The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
Week 8
Results posted on
2022-10-07
Participant Flow
The study was conducted in 2 countries at 17 sites.
A total of 102 patients were randomised. Patients were randomised (1:1) at baseline visit to either receive Oral DS107 capsules (2 g) or Placebo once daily for 8 weeks in a fasting state (minimum 8 hour fast).
Participant milestones
| Measure |
Placebo
Placebo capsules matching Oral DS107 capsules
|
Oral DS107 2g
Oral DS1072g, 4 x 500mg capsules administered orally once a day
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
36
|
35
|
|
Overall Study
NOT COMPLETED
|
15
|
16
|
Reasons for withdrawal
| Measure |
Placebo
Placebo capsules matching Oral DS107 capsules
|
Oral DS107 2g
Oral DS1072g, 4 x 500mg capsules administered orally once a day
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
8
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Adverse Event
|
1
|
4
|
Baseline Characteristics
Oral DS107 in Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=51 Participants
Placebo capsules matching Oral DS107 capsules
|
Oral DS107 2g
n=51 Participants
Oral DS107 2g, 4 x 500mg capsules administered orally once a day
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 15.7 • n=99 Participants
|
35.7 years
STANDARD_DEVIATION 13.6 • n=107 Participants
|
39.8 years
STANDARD_DEVIATION 15.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses.
The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo capsules matching Oral DS107 capsules
|
Oral DS107 2g
n=51 Participants
Oral DS1072g, 4 x 500mg capsules administered orally once a day
|
|---|---|---|
|
Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8.
|
0.12 Proportion of participants
|
0.22 Proportion of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4 and Week 8Population: ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses.
The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo capsules matching Oral DS107 capsules
|
Oral DS107 2g
n=51 Participants
Oral DS1072g, 4 x 500mg capsules administered orally once a day
|
|---|---|---|
|
Change From Baseline in IGA at Week 2, 4 and 8.
Week 4
|
-0.4 units on a scale
Standard Deviation 0.6
|
-0.9 units on a scale
Standard Deviation 0.7
|
|
Change From Baseline in IGA at Week 2, 4 and 8.
Week 2
|
-0.2 units on a scale
Standard Deviation 0.4
|
-0.4 units on a scale
Standard Deviation 0.7
|
|
Change From Baseline in IGA at Week 2, 4 and 8.
Week 8
|
-0.9 units on a scale
Standard Deviation 0.8
|
-1.3 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4 and Week 8Population: ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses
EASI quantifies the severity of a patient's AD based on both lesion severity and the percent of BSA affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted): * 0 = no symptoms * 1 = slight * 2 = moderate * 3 = marked A decrease in EASI score indicates a positive outcome for the participant.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo capsules matching Oral DS107 capsules
|
Oral DS107 2g
n=51 Participants
Oral DS1072g, 4 x 500mg capsules administered orally once a day
|
|---|---|---|
|
Change From Baseline in Eczema Area and Severity Index (EASI) at Week 2, 4 and 8.
Week 2
|
-1.2 units on a scale
Standard Deviation 3.6
|
-2.8 units on a scale
Standard Deviation 5.1
|
|
Change From Baseline in Eczema Area and Severity Index (EASI) at Week 2, 4 and 8.
Week 4
|
-5.2 units on a scale
Standard Deviation 7.9
|
-7.2 units on a scale
Standard Deviation 8.5
|
|
Change From Baseline in Eczema Area and Severity Index (EASI) at Week 2, 4 and 8.
Week 8
|
-8.4 units on a scale
Standard Deviation 9.5
|
-9.4 units on a scale
Standard Deviation 11.11
|
SECONDARY outcome
Timeframe: Up to 8 weeks.Population: ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses
The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo capsules matching Oral DS107 capsules
|
Oral DS107 2g
n=51 Participants
Oral DS1072g, 4 x 500mg capsules administered orally once a day
|
|---|---|---|
|
Proportion of Patients Achieving at Least a 1-point Decrease in IGA at Week 8.
|
0.43 Proportion of participants
|
0.51 Proportion of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4 and Week 8Population: ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses
The Patient-Oriented Eczema Measure (POEM) is a self-assessment of disease severity by the patient. POEM has a maximum value of twenty-eight based on the patient's response to seven questions scored according to the following scale: * No Days = 0 * 1-2 Days = 1 * 3-4 Days = 2 * 5-6 Days = 3 * Everyday = 4 POEM scale ranges from 0 to 28. 0 to 2 = clear or almost clear. 3 to 7 = mild eczema. 8 to 16 = moderate eczema. 17 to 24 = severe eczema. 25 to 28 = very severe eczema. Lower scores on the scale represent a better outcome for the patient.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo capsules matching Oral DS107 capsules
|
Oral DS107 2g
n=51 Participants
Oral DS1072g, 4 x 500mg capsules administered orally once a day
|
|---|---|---|
|
Change From Baseline in the Patient Orientated Eczema Measure (POEM) at Week 2, 4 and 8.
Week 2
|
-3.5 score on a scale
Standard Deviation 5.6
|
-5.0 score on a scale
Standard Deviation 5.6
|
|
Change From Baseline in the Patient Orientated Eczema Measure (POEM) at Week 2, 4 and 8.
Week 4
|
-4.0 score on a scale
Standard Deviation 6.5
|
-6.9 score on a scale
Standard Deviation 6.3
|
|
Change From Baseline in the Patient Orientated Eczema Measure (POEM) at Week 2, 4 and 8.
Week 8
|
-5.0 score on a scale
Standard Deviation 7.7
|
-5.7 score on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4 and Week 8Population: ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses
The DLQI is a simple 10-question validated questionnaire measuring the impact of a patients skin problem over a 1 week period, which was completed at each visit, except screening. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo capsules matching Oral DS107 capsules
|
Oral DS107 2g
n=51 Participants
Oral DS1072g, 4 x 500mg capsules administered orally once a day
|
|---|---|---|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at Week 2, 4 and 8.
Week 2
|
-3.6 score on a scale
Standard Deviation 5.5
|
-4.2 score on a scale
Standard Deviation 5.5
|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at Week 2, 4 and 8.
Week 4
|
-5.0 score on a scale
Standard Deviation 6.0
|
-6.5 score on a scale
Standard Deviation 5.9
|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at Week 2, 4 and 8.
Week 8
|
-4.9 score on a scale
Standard Deviation 5.5
|
-5.5 score on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4 and Week 8Population: ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses
The SCORAD grading system was developed by the European Task Force on Atopic Dermatitis and has been a standard tool to assess the AD severity in clinical studies. Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) was selected to evaluate the AD severity. The intensity of each item is graded using a 4-point scale: * 0 = No symptoms * 1 = Mild * 2 = Moderate * 3 = Severe The overall BSA affected by AD was evaluated (from 0 to 100%) and included in the SCORAD scores. Loss of sleep and pruritus were evaluated by patients on a visual analog scale (0-10). The sum of these measures represents the SCORAD which can vary from 0 to 103. A decrease in SCORAD indicates a positive outcome for the participant.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo capsules matching Oral DS107 capsules
|
Oral DS107 2g
n=51 Participants
Oral DS1072g, 4 x 500mg capsules administered orally once a day
|
|---|---|---|
|
Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 2, 4 and 8.
Week 2
|
-5.3 score on a scale
Standard Deviation 8.7
|
-6.6 score on a scale
Standard Deviation 10.3
|
|
Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 2, 4 and 8.
Week 4
|
-10.6 score on a scale
Standard Deviation 14.7
|
-16.7 score on a scale
Standard Deviation 15.5
|
|
Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 2, 4 and 8.
Week 8
|
-18.3 score on a scale
Standard Deviation 18.4
|
-21.1 score on a scale
Standard Deviation 21.7
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4 and Week 8Population: ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses
The pruritus severity score was recorded with the SCORAD measurement and was evaluated as a separate endpoint. This was evaluated by asking subjects to indicate on the 10-cm scale (0-10) of the assessment form the point corresponding to the average value for the last three days/nights. A lower score represents a better outcome for the patient.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo capsules matching Oral DS107 capsules
|
Oral DS107 2g
n=51 Participants
Oral DS1072g, 4 x 500mg capsules administered orally once a day
|
|---|---|---|
|
Change From Baseline in the Patient's Visual Analog Scale (VAS) Pruritus Score at Week 2, 4 and 8.
Week 2
|
-0.9 score on a scale
Standard Deviation 2.1
|
-1.6 score on a scale
Standard Deviation 2.5
|
|
Change From Baseline in the Patient's Visual Analog Scale (VAS) Pruritus Score at Week 2, 4 and 8.
Week 4
|
-1.1 score on a scale
Standard Deviation 2.7
|
-2.8 score on a scale
Standard Deviation 2.9
|
|
Change From Baseline in the Patient's Visual Analog Scale (VAS) Pruritus Score at Week 2, 4 and 8.
Week 8
|
-2.2 score on a scale
Standard Deviation 3.3
|
-2.8 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4 and Week 8Population: ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses
One patient's palm represents 1% of his/her total BSA. For all study visits except at screening, the BSA of involved skin will be measured with the SCORAD measurement and evaluated as a separate endpoint.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo capsules matching Oral DS107 capsules
|
Oral DS107 2g
n=51 Participants
Oral DS1072g, 4 x 500mg capsules administered orally once a day
|
|---|---|---|
|
Change From Baseline in Body Surface Area (BSA) at Week 2, 4 and 8.
Week 2
|
-0.9 percentage of BSA
Standard Deviation 4.9
|
-1.3 percentage of BSA
Standard Deviation 4.4
|
|
Change From Baseline in Body Surface Area (BSA) at Week 2, 4 and 8.
Week 4
|
-3.6 percentage of BSA
Standard Deviation 7.1
|
-5.2 percentage of BSA
Standard Deviation 7.3
|
|
Change From Baseline in Body Surface Area (BSA) at Week 2, 4 and 8.
Week 8
|
-7.0 percentage of BSA
Standard Deviation 9.6
|
-9.6 percentage of BSA
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: Up to 14 weeksPopulation: The safety population was defined as all randomised patients who received at least one dose of the medication. Analysis was done according to the actual treatment patients received.
Number of participants with at least 1 TEAE.
Outcome measures
| Measure |
Placebo
n=51 Participants
Placebo capsules matching Oral DS107 capsules
|
Oral DS107 2g
n=51 Participants
Oral DS1072g, 4 x 500mg capsules administered orally once a day
|
|---|---|---|
|
Number of Participants With TEAEs in Each Treatment Group
|
24 Participants
|
37 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Oral DS107 2g
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=51 participants at risk
Placebo capsules matching Oral DS107 capsules.
|
Oral DS107 2g
n=51 participants at risk
Oral DS107 2g, 4 x 500mg capsules administered orally once a day
|
|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Cardiac disorders
Pericarditis
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Nervous system disorders
Syncope
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
Other adverse events
| Measure |
Placebo
n=51 participants at risk
Placebo capsules matching Oral DS107 capsules.
|
Oral DS107 2g
n=51 participants at risk
Oral DS107 2g, 4 x 500mg capsules administered orally once a day
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.8%
4/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
31.4%
16/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
31.4%
16/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
15.7%
8/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
9.8%
5/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
3.9%
2/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
5.9%
3/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
5.9%
3/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
3.9%
2/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Anal Pruritus
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Faeces Discoloured
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Faeces Soft
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
General disorders
Fatigue
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Immune system disorders
Seasonal Allergy
|
3.9%
2/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
3/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
7.8%
4/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Infections and infestations
Abscess
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Infections and infestations
Skin Bacterial Infections
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Investigations
Activated Partial Thromboplastin Time Abnormal
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Investigations
Blood Test Abnormal
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.9%
2/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Nervous system disorders
Headache
|
9.8%
5/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Nervous system disorders
Dysgeusia
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Nervous system disorders
Restless Leg Syndrome
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Renal and urinary disorders
Proteinuria
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Reproductive system and breast disorders
Premenstrual Cramps
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
5.9%
3/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
3.9%
2/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.0%
1/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
0.00%
0/51 • Up to 14 weeks.
An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place