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A Study to Evaluate the Safety and Efficacy of RDX5791 for the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C)

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of RDX5791 for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01340053
Enrollment
186
Registered
2011-04-22
Start date
2011-05-31
Completion date
2012-02-29
Last updated
2019-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation Predominant Irritable Bowel Syndrome

Brief summary

This is a multi-center, Phase 2, randomized, double-blind, placebo controlled study of RDX5791 in subjects with IBS-C. Patients who are 18 to 75 years old, meeting the definition of IBS-C as defined by the Rome III Criteria for the Diagnosis of IBS will undergo a battery of screening procedures to determine eligibility for the trial. The study will consist of a 2-week treatment-free screening period, a 4-week blinded treatment period, and a 2-week treatment-free follow-up period.

Interventions

DRUGRDX5791

Capsule, QD

Sponsors

Ardelyx
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Subject meets Rome III criteria for IBS-C * If \> 50 years old, colonoscopy evaluation within 10 years * All ages, negative colonoscopy if any warning symptoms * Active disease during 2-week screening period * Compliant with IVRS

Exclusion criteria

* Subjects has IBS-D, IBS-M or un-subtyped IBS according to Rome III criteria * Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract * Use of medications that are known to affect stool consistency * Subject has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments or prevent completion of study

Design outcomes

Primary

MeasureTime frameDescription
Complete Spontaneous Bowel Movement (CSBM) Frequency Change From BaselineBaseline and Week 4Patients 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.

Secondary

MeasureTime frame
Spontaneous Bowel Movement (SBM) Frequency Change From Baselinebaseline and week 4

Countries

United States

Participant flow

Participants by arm

ArmCount
Placebo
RDX5791: Capsule, QD
47
Low Dose
RDX5791: Capsule, QD
46
Mid Dose
RDX5791: Capsule, QD
47
High Dose
RDX5791: Capsule, QD
46
Total186

Baseline characteristics

CharacteristicPlaceboLow DoseMid DoseHigh DoseTotal
Age, Continuous47.9 years
STANDARD_DEVIATION 11.97
44.4 years
STANDARD_DEVIATION 14.15
46.5 years
STANDARD_DEVIATION 9.49
43.5 years
STANDARD_DEVIATION 12.31
45.6 years
STANDARD_DEVIATION 12.11
Body Mass Index (BMI)28.02 kg/m^2
STANDARD_DEVIATION 5.56
27.40 kg/m^2
STANDARD_DEVIATION 6.97
28.58 kg/m^2
STANDARD_DEVIATION 6.1
28.10 kg/m^2
STANDARD_DEVIATION 4.14
28.03 kg/m^2
STANDARD_DEVIATION 5.74
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants6 Participants5 Participants8 Participants22 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
44 Participants40 Participants42 Participants38 Participants164 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants0 Participants0 Participants3 Participants
Race (NIH/OMB)
Black or African American
12 Participants5 Participants9 Participants10 Participants36 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
34 Participants39 Participants38 Participants36 Participants147 Participants
Sex: Female, Male
Female
39 Participants42 Participants39 Participants37 Participants157 Participants
Sex: Female, Male
Male
8 Participants4 Participants8 Participants9 Participants29 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 470 / 460 / 470 / 46
other
Total, other adverse events
0 / 470 / 460 / 470 / 46
serious
Total, serious adverse events
0 / 472 / 460 / 470 / 46

Outcome results

Primary

Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline

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.

Time frame: Baseline and Week 4

Population: All patients randomized who received at least one dose of drug

ArmMeasureValue (MEAN)Dispersion
PlaceboComplete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline1.01 number of bowel movements/weekStandard Deviation 2.03
Low DoseComplete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline1.50 number of bowel movements/weekStandard Deviation 2.09
Mid DoseComplete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline1.54 number of bowel movements/weekStandard Deviation 2.1
High DoseComplete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline1.57 number of bowel movements/weekStandard Deviation 2.5
Secondary

Spontaneous Bowel Movement (SBM) Frequency Change From Baseline

Time frame: baseline and week 4

ArmMeasureValue (MEAN)Dispersion
PlaceboSpontaneous Bowel Movement (SBM) Frequency Change From Baseline1.58 change in number of bowel movementsStandard Deviation 2.51
Low DoseSpontaneous Bowel Movement (SBM) Frequency Change From Baseline2.37 change in number of bowel movementsStandard Deviation 2.27
Mid DoseSpontaneous Bowel Movement (SBM) Frequency Change From Baseline2.97 change in number of bowel movementsStandard Deviation 3.13
High DoseSpontaneous Bowel Movement (SBM) Frequency Change From Baseline2.81 change in number of bowel movementsStandard Deviation 3.14

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026