Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C) (NCT NCT01340053)
NCT ID: NCT01340053
Last Updated: 2019-10-15
Results Overview
Patients complete a phone diary daily. They are asked "how many bowel movements have you had today?" they are then asked for each spontaneous bowel movement (unaided with laxative use) wether there was its was a complete evacuation. if it was then it is a complete spontaneous bowel movement. All CSBMs are added and adjusted for a mean compete sponteneous bowel movement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
186 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2019-10-15
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Capsule, QD
|
10mg
RDX5791: Capsule, QD
|
30 mg
RDX5791: Capsule, QD
|
100 mg
RDX5791: Capsule, QD
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
46
|
47
|
46
|
|
Overall Study
COMPLETED
|
43
|
44
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)
Baseline characteristics by cohort
| Measure |
Placebo
n=47 Participants
RDX5791: Capsule, QD
|
Low Dose
n=46 Participants
RDX5791: Capsule, QD
|
Mid Dose
n=47 Participants
RDX5791: Capsule, QD
|
High Dose
n=46 Participants
RDX5791: Capsule, QD
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
28.02 kg/m^2
STANDARD_DEVIATION 5.56 • n=5 Participants
|
27.40 kg/m^2
STANDARD_DEVIATION 6.97 • n=7 Participants
|
28.58 kg/m^2
STANDARD_DEVIATION 6.10 • n=5 Participants
|
28.10 kg/m^2
STANDARD_DEVIATION 4.14 • n=4 Participants
|
28.03 kg/m^2
STANDARD_DEVIATION 5.74 • n=21 Participants
|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 11.97 • n=5 Participants
|
44.4 years
STANDARD_DEVIATION 14.15 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 9.49 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 12.31 • n=4 Participants
|
45.6 years
STANDARD_DEVIATION 12.11 • n=21 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
157 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
164 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
147 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: All patients randomized who received at least one dose of drug
Patients complete a phone diary daily. They are asked "how many bowel movements have you had today?" they are then asked for each spontaneous bowel movement (unaided with laxative use) wether there was its was a complete evacuation. if it was then it is a complete spontaneous bowel movement. All CSBMs are added and adjusted for a mean compete sponteneous bowel movement.
Outcome measures
| Measure |
Placebo
n=47 Participants
RDX5791: Capsule, QD
|
Low Dose
n=45 Participants
RDX5791: Capsule, QD
|
Mid Dose
n=47 Participants
RDX5791: Capsule, QD
|
High Dose
n=46 Participants
RDX5791: Capsule, QD
|
|---|---|---|---|---|
|
Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline
|
1.01 number of bowel movements/week
Standard Deviation 2.03
|
1.50 number of bowel movements/week
Standard Deviation 2.09
|
1.54 number of bowel movements/week
Standard Deviation 2.10
|
1.57 number of bowel movements/week
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: baseline and week 4Outcome measures
| Measure |
Placebo
n=47 Participants
RDX5791: Capsule, QD
|
Low Dose
n=45 Participants
RDX5791: Capsule, QD
|
Mid Dose
n=47 Participants
RDX5791: Capsule, QD
|
High Dose
n=46 Participants
RDX5791: Capsule, QD
|
|---|---|---|---|---|
|
Spontaneous Bowel Movement (SBM) Frequency Change From Baseline
|
1.58 change in number of bowel movements
Standard Deviation 2.51
|
2.37 change in number of bowel movements
Standard Deviation 2.27
|
2.97 change in number of bowel movements
Standard Deviation 3.13
|
2.81 change in number of bowel movements
Standard Deviation 3.14
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Dose
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Mid Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=47 participants at risk
RDX5791: Capsule, QD
|
Low Dose
n=46 participants at risk
RDX5791: Capsule, QD
|
Mid Dose
n=47 participants at risk
RDX5791: Capsule, QD
|
High Dose
n=46 participants at risk
RDX5791: Capsule, QD
|
|---|---|---|---|---|
|
Gastrointestinal disorders
cholecystitis
|
0.00%
0/47
|
2.2%
1/46 • Number of events 1
|
0.00%
0/47
|
0.00%
0/46
|
|
Gastrointestinal disorders
appendicitis
|
0.00%
0/47
|
2.2%
1/46 • Number of events 1
|
0.00%
0/47
|
0.00%
0/46
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publications must be reviewed and approved by sponsor
- Publication restrictions are in place
Restriction type: OTHER