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

• Sponsor: Ardelyx (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01340053
• Collaborator: (none)
• Enrollment: 186
• Locations: 16
• Arms: 4
• Duration (Months): 9.1
• Patients Per Site: 11.6
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Constipation Predominant Irritable Bowel Syndrome	Drug: RDX5791	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 186 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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)
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Capsule that is identical in size and color to other treatments	Drug: RDX5791; Capsule, QD
Experimental: Low Dose 10 mg capsule of tenapanor	Drug: RDX5791; Capsule, QD
Experimental: Mid Dose 30 mg capsule of tenapanor	Drug: RDX5791; Capsule, QD
Experimental: High Dose 100 mg capsule of tenapanor	Drug: RDX5791; Capsule, QD

Outcome Measures

Primary Outcome Measures

1. Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline [Baseline and Week 4]

   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.

Secondary Outcome Measures

1. Spontaneous Bowel Movement (SBM) Frequency Change From Baseline [baseline and week 4]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ardelyx Investigational Site	San Diego	California	United States	92108
2	Ardelyx Investigational Site	Jupiter	Florida	United States	33458
3	Ardelyx Investigational Site	Pinellas Park	Florida	United States	33782
4	Ardelyx Investigational Site	Rockford	Illinois	United States	61107
5	Ardelyx Investigational Site	Mission	Kansas	United States	66202
6	Ardelyx Investigational Site	Monroe	Louisiana	United States	71201
7	Ardelyx Investigational Site	Annapolis	Maryland	United States	21401
8	Ardelyx Investigational Site	Chesterfield	Michigan	United States	48047
9	Ardelyx Investigational Site	Saint Louis	Missouri	United States	63128
10	Ardelyx Investigational Site	Brooklyn	New York	United States	11214
11	Ardelyx Investigational Site	Greensboro	North Carolina	United States	27408
12	Ardelyx Investigational Site	Oklahoma City	Oklahoma	United States	73104
13	Ardelyx Investigational Site	Simpsonville	South Carolina	United States	29681
14	Ardelyx Investigational Site	Bristol	Tennessee	United States	37620
15	Ardelyx Investigational Site	Ogden	Utah	United States	84405
16	Ardelyx Investigational Site	Lynchburg	Virginia	United States	24502

Sponsors and Collaborators

• Ardelyx

Investigators

• Study Chair: David P Rosenbaum, Ph.D., Ardelyx

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Ardelyx
• ClinicalTrials.gov Identifier: NCT01340053
• Other Study ID Numbers: RDX5791-201
• First Posted: Apr 22, 2011
• Last Update Posted: Oct 15, 2019
• Last Verified: Sep 1, 2019

• Additional relevant MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation

Study Results

Participant Flow

Arm/Group Title	Placebo	10mg	30 mg	100 mg
Arm/Group Description	Placebo: Capsule, QD	RDX5791: Capsule, QD	RDX5791: Capsule, QD	RDX5791: Capsule, QD
Period Title: Overall Study
STARTED	47	46	47	46
COMPLETED	43	44	43	43
NOT COMPLETED	4	2	4	3

Baseline Characteristics

Arm/Group Title	Placebo	Low Dose	Mid Dose	High Dose	Total
Arm/Group Description	RDX5791: Capsule, QD	RDX5791: Capsule, QD	RDX5791: Capsule, QD	RDX5791: Capsule, QD	Total of all reporting groups
Overall Participants	47	46	47	46	186
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.9 (11.97)	44.4 (14.15)	46.5 (9.49)	43.5 (12.31)	45.6 (12.11)
Sex: Female, Male (Count of Participants)
Female	39 83%	42 91.3%	39 83%	37 80.4%	157 84.4%
Male	8 17%	4 8.7%	8 17%	9 19.6%	29 15.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 6.4%	6 13%	5 10.6%	8 17.4%	22 11.8%
Not Hispanic or Latino	44 93.6%	40 87%	42 89.4%	38 82.6%	164 88.2%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	1 2.1%	2 4.3%	0 0%	0 0%	3 1.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	12 25.5%	5 10.9%	9 19.1%	10 21.7%	36 19.4%
White	34 72.3%	39 84.8%	38 80.9%	36 78.3%	147 79%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.02 (5.56)	27.40 (6.97)	28.58 (6.10)	28.10 (4.14)	28.03 (5.74)

Outcome Measures

1. Primary Outcome

Title	Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline
Description	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

Outcome Measure Data

Analysis Population Description

All patients randomized who received at least one dose of drug

Arm/Group Title	Placebo	Low Dose	Mid Dose	High Dose
Arm/Group Description	RDX5791: Capsule, QD	RDX5791: Capsule, QD	RDX5791: Capsule, QD	RDX5791: Capsule, QD
Measure Participants	47	45	47	46
Mean (Standard Deviation) [number of bowel movements/week]	1.01 (2.03)	1.50 (2.09)	1.54 (2.10)	1.57 (2.50)

2. Secondary Outcome

Title	Spontaneous Bowel Movement (SBM) Frequency Change From Baseline
Time Frame	baseline and week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Low Dose	Mid Dose	High Dose
Arm/Group Description	RDX5791: Capsule, QD	RDX5791: Capsule, QD	RDX5791: Capsule, QD	RDX5791: Capsule, QD
Measure Participants	47	45	47	46
Mean (Standard Deviation) [change in number of bowel movements]	1.58 (2.51)	2.37 (2.27)	2.97 (3.13)	2.81 (3.14)

Adverse Events

Arm/Group Title	Placebo		Low Dose		Mid Dose		High Dose
Arm/Group Description	RDX5791: Capsule, QD		RDX5791: Capsule, QD		RDX5791: Capsule, QD		RDX5791: Capsule, QD
All Cause Mortality
	Placebo		Low Dose		Mid Dose		High Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/46 (0%)
Serious Adverse Events
	Placebo		Low Dose		Mid Dose		High Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/47 (0%)		2/46 (4.3%)		0/47 (0%)		0/46 (0%)
Gastrointestinal disorders
cholecystitis	0/47 (0%)	0	1/46 (2.2%)	1	0/47 (0%)	0	0/46 (0%)	0
appendicitis	0/47 (0%)	0	1/46 (2.2%)	1	0/47 (0%)	0	0/46 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		Low Dose		Mid Dose		High Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/47 (0%)		0/46 (0%)		0/47 (0%)		0/46 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Publications must be reviewed and approved by sponsor