Trial Outcomes & Findings for Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis (NCT NCT01008423)
NCT ID: NCT01008423
Last Updated: 2019-08-14
Results Overview
Remission was a combined assessment of clinical and endoscopic variables, defined as an endoscopy score of less than or equal to (\<=) 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI) at the end of 6 weeks of treatment. MMDAI was used to assess the overall disease activity for each participant. MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment (PGA) and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Stool frequency MMDAI subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Endoscopy MMDAI subscore ranged from 0-3, where 0 indicated normal or inactive disease and 3 indicated severe disease (spontaneous bleeding, ulceration).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
281 participants
Primary outcome timeframe
Week 6
Results posted on
2019-08-14
Participant Flow
Participant milestones
| Measure |
Budesonide
Participants who were diagnosed with active mild to moderate ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS), received 2 milligrams (mg)/25 milliliter (mL) of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
|
Placebo
Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
147
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
134
|
147
|
|
Overall Study
COMPLETED
|
115
|
125
|
|
Overall Study
NOT COMPLETED
|
19
|
22
|
Reasons for withdrawal
| Measure |
Budesonide
Participants who were diagnosed with active mild to moderate ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS), received 2 milligrams (mg)/25 milliliter (mL) of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
|
Placebo
Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
6
|
|
Overall Study
Withdrawal by Subject
|
4
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Low Cortisol
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
5
|
|
Overall Study
Disease Extent 70 centimeters (cm)
|
1
|
0
|
|
Overall Study
Personal Conflict
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
Baseline characteristics by cohort
| Measure |
Budesonide
n=134 Participants
Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
|
Placebo
n=147 Participants
Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
|
Total
n=281 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 13.47 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 13.27 • n=7 Participants
|
43.0 years
STANDARD_DEVIATION 13.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
119 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
119 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: ITT population included all randomized participants. Missing data was imputed using last observation carried forward (LOCF) method.
Remission was a combined assessment of clinical and endoscopic variables, defined as an endoscopy score of less than or equal to (\<=) 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI) at the end of 6 weeks of treatment. MMDAI was used to assess the overall disease activity for each participant. MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment (PGA) and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Stool frequency MMDAI subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Endoscopy MMDAI subscore ranged from 0-3, where 0 indicated normal or inactive disease and 3 indicated severe disease (spontaneous bleeding, ulceration).
Outcome measures
| Measure |
Budesonide
n=134 Participants
Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
|
Placebo
n=147 Participants
Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieved Remission
|
44.0 percentage of participants
|
22.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: ITT population included all randomized participants.
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices:stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Missing data was imputed using LOCF method.
Outcome measures
| Measure |
Budesonide
n=134 Participants
Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
|
Placebo
n=147 Participants
Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6
|
50.0 percentage of participants
|
28.6 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, and 6Population: ITT population included all randomized participants.
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Percentage of participants who were rectal bleeding responder at scheduled assessments were reported. Rectal bleeding responders were defined as those participants who achieved a rectal bleeding MMDAI subscale score of 0 during the treatment period. Missing data was imputed using LOCF method.
Outcome measures
| Measure |
Budesonide
n=134 Participants
Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
|
Placebo
n=147 Participants
Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
|
|---|---|---|
|
Number of Scheduled Assessments With Rectal Bleeding Responder Classification
Responder at 1 assessment
|
8.2 percentage of participants
|
18.4 percentage of participants
|
|
Number of Scheduled Assessments With Rectal Bleeding Responder Classification
Responder at 2 assessment
|
16.4 percentage of participants
|
17.0 percentage of participants
|
|
Number of Scheduled Assessments With Rectal Bleeding Responder Classification
Responder at 3 assessment
|
21.6 percentage of participants
|
7.5 percentage of participants
|
|
Number of Scheduled Assessments With Rectal Bleeding Responder Classification
Responder at 4 assessment
|
13.4 percentage of participants
|
2.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: ITT population included all randomized participants.
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscale ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease, 2 = moderate disease and 3 = severe disease (spontaneous bleeding, ulceration). Percentage of participants with normal or mild disease have been presented in this outcome measure. Missing data was imputed using LOCF method.
Outcome measures
| Measure |
Budesonide
n=134 Participants
Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
|
Placebo
n=147 Participants
Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieved an Endoscopy MMDAI Subscale Score of 0 or 1 at End of Week 6
|
56.0 percentage of participants
|
36.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: ITT population included all randomized participants.
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal disease and 3 indicated severe disease. Missing data was imputed using LOCF method.
Outcome measures
| Measure |
Budesonide
n=134 Participants
Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
|
Placebo
n=147 Participants
Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Score of 0 for Rectal Bleeding Subscale and a Combined Score of <=2 for Bowel Frequency (BF) and Physician's Global Assessment (PGA) in the MMDAI Subscales at End of Week 6
|
46.3 percentage of participants
|
23.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: ITT population included all randomized participants.
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.
Outcome measures
| Measure |
Budesonide
n=134 Participants
Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
|
Placebo
n=147 Participants
Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieved an MMDAI Total Score of <= 3 With Greater Than or Equal to (>=2) Points of Improvement From Baseline at the End of Week 6
|
49.3 percentage of participants
|
28.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: ITT population included all randomized participants.
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscore ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration). Missing data was imputed using LOCF method.
Outcome measures
| Measure |
Budesonide
n=134 Participants
Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
|
Placebo
n=147 Participants
Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Endoscopy Subscale Score at End of Week 6
|
57.5 percentage of participants
|
38.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: ITT population included all randomized participants.
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, and 3 indicated blood alone passed. Missing data was imputed using LOCF method.
Outcome measures
| Measure |
Budesonide
n=134 Participants
Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
|
Placebo
n=147 Participants
Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score at End of Week 6
|
72.4 percentage of participants
|
56.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: ITT population included all randomized participants.
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.
Outcome measures
| Measure |
Budesonide
n=134 Participants
Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
|
Placebo
n=147 Participants
Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieved >=3 Point Improvement From Baseline in the MMDAI Total Score Including Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score and MMDAI Endoscopy Subscale at End of Week 6
|
53.7 percentage of participants
|
34.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: ITT population included all randomized participants. Here, 'Number analyzed' signifies number of participants evaluable for specified categories.
The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.
Outcome measures
| Measure |
Budesonide
n=134 Participants
Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
|
Placebo
n=147 Participants
Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
|
|---|---|---|
|
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores
Bowel frequency score: Baseline
|
1.7 unit on a scale
Standard Deviation 0.95
|
1.8 unit on a scale
Standard Deviation 0.89
|
|
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores
Bowel frequency score: Change at Week 6
|
-0.8 unit on a scale
Standard Deviation 0.99
|
-0.5 unit on a scale
Standard Deviation 0.92
|
|
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores
Rectal Bleeding score:Baseline
|
2.1 unit on a scale
Standard Deviation 0.39
|
2.1 unit on a scale
Standard Deviation 0.38
|
|
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores
Rectal Bleeding score: Change at Week 6
|
-1.3 unit on a scale
Standard Deviation 0.97
|
-0.9 unit on a scale
Standard Deviation 0.93
|
|
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores
PGA score:Baseline
|
2.0 unit on a scale
Standard Deviation 0.26
|
2.0 unit on a scale
Standard Deviation 0.31
|
|
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores
PGA score: Change at Week 6
|
-0.9 unit on a scale
Standard Deviation 0.91
|
-0.6 unit on a scale
Standard Deviation 0.76
|
|
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores
Endoscopy score:Baseline
|
2.1 unit on a scale
Standard Deviation 0.33
|
2.1 unit on a scale
Standard Deviation 0.28
|
|
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores
Endoscopy score: Change at Week 6
|
-0.9 unit on a scale
Standard Deviation 0.92
|
-0.5 unit on a scale
Standard Deviation 0.79
|
|
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores
Total score:Baseline
|
7.9 unit on a scale
Standard Deviation 1.25
|
8.0 unit on a scale
Standard Deviation 1.17
|
|
Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores
Total score: Change at Week 6
|
-3.8 unit on a scale
Standard Deviation 3.20
|
-2.5 unit on a scale
Standard Deviation 2.72
|
Adverse Events
Budesonide
Serious events: 3 serious events
Other events: 57 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Budesonide
n=134 participants at risk
Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
|
Placebo
n=147 participants at risk
Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Acute generalised exanthematous pustulosis
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
Other adverse events
| Measure |
Budesonide
n=134 participants at risk
Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
|
Placebo
n=147 participants at risk
Participants who were diagnosed with active mild to moderate UP or UPS received 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
|
|---|---|---|
|
Infections and infestations
Sinusitis
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
1.4%
2/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Infections and infestations
Lymph node abscess
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
1.4%
2/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.2%
3/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
2.0%
3/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
General disorders
Pain
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
General disorders
Chills
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
2/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
1.4%
2/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
3/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
1.4%
2/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
2.0%
3/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Proctitis ulcerative
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
1.4%
2/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
1.4%
2/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.5%
2/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
1.4%
2/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
1.4%
2/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
2/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Nervous system disorders
Headache
|
1.5%
2/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
4.1%
6/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
2/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
2.0%
3/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
1.4%
2/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
1.4%
2/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
1.5%
2/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
2.0%
3/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
General disorders
Fatigue
|
1.5%
2/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
1.4%
2/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
General disorders
Asthenia
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
2.7%
4/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
2.7%
4/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Investigations
Bacterial test positive
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
1.4%
2/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Investigations
Blood cortisol decreased
|
15.7%
21/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
4.1%
6/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
2/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
1.4%
2/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Investigations
Weight increased
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Investigations
Urine ketone body present
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
General disorders
Chest discomfort
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Eye disorders
Macular hole
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.68%
1/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
General disorders
Influenza like illness
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Renal and urinary disorders
Micturition urgency
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Vascular disorders
Hypotension
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.5%
2/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Investigations
Blood bicarbonate decreased
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Investigations
Blood calcium decreased
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Investigations
Blood glucose decreased
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Investigations
Blood potassium decreased
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Investigations
Urine analysis abnormal
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Investigations
White blood cells urine positive
|
1.5%
2/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Nervous system disorders
Migraine
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.2%
3/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Investigations
White blood cell count increased
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Nervous system disorders
Tension headache
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Nervous system disorders
Burning sensation
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia effluvium
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.75%
1/134 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
0.00%
0/147 • From start of study drug up to Week 8
Safety population included all randomized participants who were administered at least one dose of the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
- Publication restrictions are in place
Restriction type: OTHER