Trial Outcomes & Findings for Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection (NCT NCT01259726)
NCT ID: NCT01259726
Last Updated: 2021-06-10
Results Overview
An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a study participant, regardless of causal relationship. TEAEs were defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug). SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
173 participants
Primary outcome timeframe
Baseline up to 7 days after the last dose of study drug (up to Week 3)
Results posted on
2021-06-10
Participant Flow
This study was conducted at a total of 44 investigative sites \[United states (US)=33, Canada=4, and Europe=7\], and 3 of the 33 US sites did not enroll any participants (each had 1 screen failure).
Of the 213 participants formally screened to participate in this study, 168 participants were treated. Five participants were randomized but not treated and 40 participants were screen failures.
Participant milestones
| Measure |
Placebo
Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
|
VP 20621 Low Dose and Placebo
VP 20621 oral liquid containing 10\^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose and Placebo
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
41
|
43
|
41
|
|
Overall Study
Treated
|
40
|
37
|
41
|
39
|
|
Overall Study
COMPLETED
|
38
|
37
|
39
|
36
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
4
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
|
VP 20621 Low Dose and Placebo
VP 20621 oral liquid containing 10\^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose and Placebo
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
|
|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
3
|
Baseline Characteristics
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
Baseline characteristics by cohort
| Measure |
Placebo
n=43 Participants
Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
|
VP 20621 Low Dose and Placebo
n=41 Participants
VP 20621 oral liquid containing 10\^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose and Placebo
n=43 Participants
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose
n=41 Participants
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 19.19 • n=93 Participants
|
58.2 years
STANDARD_DEVIATION 14.42 • n=4 Participants
|
57.2 years
STANDARD_DEVIATION 18.46 • n=27 Participants
|
60.6 years
STANDARD_DEVIATION 16.4 • n=483 Participants
|
57.6 years
STANDARD_DEVIATION 17.2 • n=36 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
104 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
64 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 7 days after the last dose of study drug (up to Week 3)Population: Intent-to-Treat-Safety (ITT-S) population was defined as all randomized participants who received at least 1 dose of study drug.
An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a study participant, regardless of causal relationship. TEAEs were defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug). SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement.
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
|
VP 20621 Low Dose and Placebo
n=41 Participants
VP 20621 oral liquid containing 10\^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose and Placebo
n=43 Participants
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose
n=41 Participants
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with TEAEs
|
37 Participants
|
33 Participants
|
34 Participants
|
31 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with treatment-emergent SAEs
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: After study drug administration period (14 days) through Week 6Population: ITT-S population.
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
|
VP 20621 Low Dose and Placebo
n=41 Participants
VP 20621 oral liquid containing 10\^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose and Placebo
n=43 Participants
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose
n=41 Participants
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
|
|---|---|---|---|---|
|
Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3
|
4 Participants
|
26 Participants
|
31 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 6Population: ITT-S population.
CDI recurrence was defined as at least 1 event characterized by ALL of the following: \>=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea case report form (CRF) page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator.
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
|
VP 20621 Low Dose and Placebo
n=41 Participants
VP 20621 oral liquid containing 10\^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose and Placebo
n=43 Participants
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose
n=41 Participants
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
|
|---|---|---|---|---|
|
Number of Participants With Clostridium Difficile Infection (CDI) Recurrence
|
13 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 6Population: ITT-S population.
Any antibacterial medication used after Day 1 for which the investigator selected the indication "antibacterial for C. difficile infection".
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
|
VP 20621 Low Dose and Placebo
n=41 Participants
VP 20621 oral liquid containing 10\^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose and Placebo
n=43 Participants
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose
n=41 Participants
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
|
|---|---|---|---|---|
|
Number of Participants With Use of Antibacterial Treatment for CDI
|
14 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 6Population: ITT-S population.
Data were derived from all AEs starting on or after Day 1 for which a Diarrhea CRF page was completed.
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
|
VP 20621 Low Dose and Placebo
n=41 Participants
VP 20621 oral liquid containing 10\^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose and Placebo
n=43 Participants
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose
n=41 Participants
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
|
|---|---|---|---|---|
|
Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools
|
33 Participants
|
23 Participants
|
25 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 6Population: ITT-S population
CDI recurrence was defined as at least 1 event characterized by ALL of the following: \>=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea CRF page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator. Time of onset is from date of randomization to date of first CDI recurrence. Time to first CDI recurrence was assessed using Kaplan-Meier curve. Due to small number of subjects (\<50%) with CDI recurrence, median time to event was not evaluable.
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
|
VP 20621 Low Dose and Placebo
n=41 Participants
VP 20621 oral liquid containing 10\^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose and Placebo
n=43 Participants
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
|
VP 20621 High Dose
n=41 Participants
VP 20621 oral liquid containing 10\^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
|
|---|---|---|---|---|
|
Time to First CDI Recurrence
|
NA days
Due to small number of subjects (\<50%) with CDI recurrence, median time to event was not evaluable.
|
NA days
Due to small number of subjects (\<50%) with CDI recurrence, median time to event was not evaluable.
|
NA days
Due to small number of subjects (\<50%) with CDI recurrence, median time to event was not evaluable.
|
NA days
Due to small number of subjects (\<50%) with CDI recurrence, median time to event was not evaluable.
|
Adverse Events
Placebo
Serious events: 8 serious events
Other events: 37 other events
Deaths: 0 deaths
VP20621 Low Dose and Placebo
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
VP20621 High Dose and Placebo
Serious events: 8 serious events
Other events: 34 other events
Deaths: 0 deaths
VP20621 High Dose
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=43 participants at risk
Placebo: 10 mL placebo once daily for 14 days
|
VP20621 Low Dose and Placebo
n=41 participants at risk
VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days
|
VP20621 High Dose and Placebo
n=43 participants at risk
VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days
|
VP20621 High Dose
n=41 participants at risk
VP20621: VP20621 as oral liquid once daily for 14 days
|
|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/43 • Up to 26 Weeks
|
2.4%
1/41 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/43 • Up to 26 Weeks
|
2.4%
1/41 • Number of events 1 • Up to 26 Weeks
|
2.3%
1/43 • Number of events 3 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
2.3%
1/43 • Number of events 3 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Congenital, familial and genetic disorders
Cerebrovascular arteriovenous malformation
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
2.4%
1/41 • Number of events 1 • Up to 26 Weeks
|
|
General disorders
Chest pain
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
General disorders
Non-Cardiac chest pain
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
General disorders
Pyrexia
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
4.7%
2/43 • Number of events 2 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Infections and infestations
Clostridial infection
|
7.0%
3/43 • Number of events 3 • Up to 26 Weeks
|
2.4%
1/41 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Infections and infestations
Enteritis infectious
|
2.3%
1/43 • Number of events 2 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Infections and infestations
Influenza
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Infections and infestations
Meningitis
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
2.4%
1/41 • Number of events 1 • Up to 26 Weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
2.4%
1/41 • Number of events 1 • Up to 26 Weeks
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
2.4%
1/41 • Number of events 1 • Up to 26 Weeks
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
2.4%
1/41 • Number of events 1 • Up to 26 Weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
4.9%
2/41 • Number of events 2 • Up to 26 Weeks
|
|
Infections and infestations
Septic shock
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
4.9%
2/41 • Number of events 2 • Up to 26 Weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
2.4%
1/41 • Number of events 1 • Up to 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
2.4%
1/41 • Number of events 1 • Up to 26 Weeks
|
|
Nervous system disorders
Headache
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/43 • Up to 26 Weeks
|
2.4%
1/41 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Nervous system disorders
Lacunar infarction
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Nervous system disorders
Myoclonus
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
2.3%
1/43 • Number of events 2 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Psychiatric disorders
Dependence
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
4.7%
2/43 • Number of events 2 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
4.9%
2/41 • Number of events 2 • Up to 26 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/43 • Up to 26 Weeks
|
4.9%
2/41 • Number of events 3 • Up to 26 Weeks
|
7.0%
3/43 • Number of events 3 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/43 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
2.3%
1/43 • Number of events 2 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
Other adverse events
| Measure |
Placebo
n=43 participants at risk
Placebo: 10 mL placebo once daily for 14 days
|
VP20621 Low Dose and Placebo
n=41 participants at risk
VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days
|
VP20621 High Dose and Placebo
n=43 participants at risk
VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days
|
VP20621 High Dose
n=41 participants at risk
VP20621: VP20621 as oral liquid once daily for 14 days
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
4.7%
2/43 • Number of events 2 • Up to 26 Weeks
|
2.4%
1/41 • Number of events 1 • Up to 26 Weeks
|
4.7%
2/43 • Number of events 2 • Up to 26 Weeks
|
7.3%
3/41 • Number of events 6 • Up to 26 Weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
37.2%
16/43 • Number of events 25 • Up to 26 Weeks
|
14.6%
6/41 • Number of events 14 • Up to 26 Weeks
|
20.9%
9/43 • Number of events 11 • Up to 26 Weeks
|
22.0%
9/41 • Number of events 15 • Up to 26 Weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
12.2%
5/41 • Number of events 5 • Up to 26 Weeks
|
4.7%
2/43 • Number of events 2 • Up to 26 Weeks
|
7.3%
3/41 • Number of events 5 • Up to 26 Weeks
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
4.9%
2/41 • Number of events 2 • Up to 26 Weeks
|
4.7%
2/43 • Number of events 2 • Up to 26 Weeks
|
9.8%
4/41 • Number of events 4 • Up to 26 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
69.8%
30/43 • Number of events 117 • Up to 26 Weeks
|
51.2%
21/41 • Number of events 69 • Up to 26 Weeks
|
62.8%
27/43 • Number of events 84 • Up to 26 Weeks
|
58.5%
24/41 • Number of events 82 • Up to 26 Weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
9.3%
4/43 • Number of events 4 • Up to 26 Weeks
|
2.4%
1/41 • Number of events 1 • Up to 26 Weeks
|
4.7%
2/43 • Number of events 3 • Up to 26 Weeks
|
12.2%
5/41 • Number of events 7 • Up to 26 Weeks
|
|
Gastrointestinal disorders
Flatulence
|
16.3%
7/43 • Number of events 7 • Up to 26 Weeks
|
22.0%
9/41 • Number of events 11 • Up to 26 Weeks
|
23.3%
10/43 • Number of events 10 • Up to 26 Weeks
|
14.6%
6/41 • Number of events 9 • Up to 26 Weeks
|
|
Gastrointestinal disorders
Nausea
|
9.3%
4/43 • Number of events 9 • Up to 26 Weeks
|
12.2%
5/41 • Number of events 7 • Up to 26 Weeks
|
9.3%
4/43 • Number of events 5 • Up to 26 Weeks
|
4.9%
2/41 • Number of events 2 • Up to 26 Weeks
|
|
Infections and infestations
Clostridial infection
|
20.9%
9/43 • Number of events 13 • Up to 26 Weeks
|
4.9%
2/41 • Number of events 2 • Up to 26 Weeks
|
4.7%
2/43 • Number of events 3 • Up to 26 Weeks
|
9.8%
4/41 • Number of events 4 • Up to 26 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
9.3%
4/43 • Number of events 4 • Up to 26 Weeks
|
2.4%
1/41 • Number of events 1 • Up to 26 Weeks
|
2.3%
1/43 • Number of events 2 • Up to 26 Weeks
|
7.3%
3/41 • Number of events 3 • Up to 26 Weeks
|
|
Infections and infestations
Urinary tract infection
|
2.3%
1/43 • Number of events 3 • Up to 26 Weeks
|
2.4%
1/41 • Number of events 1 • Up to 26 Weeks
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
14.6%
6/41 • Number of events 7 • Up to 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
7.3%
3/41 • Number of events 3 • Up to 26 Weeks
|
|
Nervous system disorders
Headache
|
4.7%
2/43 • Number of events 3 • Up to 26 Weeks
|
14.6%
6/41 • Number of events 11 • Up to 26 Weeks
|
9.3%
4/43 • Number of events 6 • Up to 26 Weeks
|
7.3%
3/41 • Number of events 3 • Up to 26 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.7%
2/43 • Number of events 2 • Up to 26 Weeks
|
7.3%
3/41 • Number of events 3 • Up to 26 Weeks
|
2.3%
1/43 • Number of events 1 • Up to 26 Weeks
|
0.00%
0/41 • Up to 26 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER