Trial Outcomes & Findings for Safety and Efficacy Study of a Novel Ointment to Treat Plaque Type Psoriasis (NCT NCT01029405)
NCT ID: NCT01029405
Last Updated: 2017-03-07
Results Overview
OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicates more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (2% twice daily) treated plaque versus (vs.) vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (2% twice daily) treated plaque respectively at Day 42 are reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
145 participants
Primary outcome timeframe
Day 42
Results posted on
2017-03-07
Participant Flow
Participant milestones
| Measure |
AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily
AN2728 ointment B 0.5 percent (%) and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily
AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily
AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily
AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
37
|
35
|
37
|
|
Overall Study
COMPLETED
|
34
|
34
|
31
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
4
|
5
|
Reasons for withdrawal
| Measure |
AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily
AN2728 ointment B 0.5 percent (%) and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily
AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily
AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily
AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
2
|
|
Overall Study
Other
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Study of a Novel Ointment to Treat Plaque Type Psoriasis
Baseline characteristics by cohort
| Measure |
AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily
n=36 Participants
AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily
n=37 Participants
AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily
n=35 Participants
AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily
n=37 Participants
AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
134 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Gender
Male
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
127 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 42Population: Intent-to-treat population included all randomized participants who received study medication.
OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicates more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (2% twice daily) treated plaque versus (vs.) vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (2% twice daily) treated plaque respectively at Day 42 are reported.
Outcome measures
| Measure |
AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily
n=37 Participants
AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily
AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily
AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
|---|---|---|---|
|
Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle
Ointment Treated Plaque vs. Vehicle Treated Plaque
|
54.1 percenatge of participants
|
—
|
—
|
|
Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle
Vehicle Treated Plaque vs. Ointment Treated Plaque
|
2.7 percenatge of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 42Population: Intent-to-treat population included all randomized participants who received the study medication.
OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher scores indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque versus vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque respectively at Day 42 are reported.
Outcome measures
| Measure |
AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily
n=36 Participants
AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily
n=37 Participants
AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily
n=35 Participants
AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
|---|---|---|---|
|
Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle
Ointment Treated Plaque vs. Vehicle Treated Plaque
|
30.6 percenatge of participants
|
43.2 percenatge of participants
|
40.0 percenatge of participants
|
|
Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle
Vehicle Treated Plaque vs. Ointment Treated Plaque
|
11.1 percenatge of participants
|
8.1 percenatge of participants
|
0.0 percenatge of participants
|
Adverse Events
AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily
n=36 participants at risk
AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily
n=37 participants at risk
AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily
n=34 participants at risk
AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily
n=37 participants at risk
AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia megaloblastic
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Eye disorders
Conjunctivitis
|
2.8%
1/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
General disorders
Pain
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
General disorders
Swelling
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.9%
1/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Infections and infestations
Ear infection
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Infections and infestations
Furuncle
|
2.8%
1/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.9%
1/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Infections and infestations
Influenza
|
8.3%
3/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
8.1%
3/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Infections and infestations
Otitis media acute
|
2.8%
1/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Infections and infestations
Pharyngitis
|
5.6%
2/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.9%
1/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Infections and infestations
Pharyngotonsillitis
|
2.8%
1/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
5.9%
2/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.9%
1/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.9%
1/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.9%
1/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.9%
1/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.8%
1/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
2.8%
1/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Injury, poisoning and procedural complications
Penis injury
|
0.00%
0/30
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/33
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
3.3%
1/30
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/33
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Investigations
Transaminases increased
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.9%
1/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.9%
1/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
1/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
1/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.9%
1/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
5.4%
2/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.8%
1/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.9%
1/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
8.1%
3/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.8%
1/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
5.4%
2/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.9%
1/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
16.2%
6/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.9%
1/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
2.8%
1/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.9%
1/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Vascular disorders
Hypertension
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.9%
1/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/36
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
0.00%
0/34
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
2.7%
1/37
Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER