Constipation Predominant Irritable Bowel SyndromePhase 2NCT01340053

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

A Phase 2 study testing RDX5791 in people with Constipation Predominant Irritable Bowel Syndrome, run by Ardelyx at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Constipation Predominant Irritable Bowel Syndrome
What is being tested?: RDX5791
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 186 participants
Where: 16 sitesUnited States
Study dates: May 2011to Feb 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Ardelyx Investigational Site
Annapolis, Maryland, 21401
Ardelyx Investigational Site
Bristol, Tennessee, 37620
Ardelyx Investigational Site
Brooklyn, New York, 11214
Ardelyx Investigational Site
Chesterfield, Michigan, 48047
Ardelyx Investigational Site
Greensboro, North Carolina, 27408
Ardelyx Investigational Site
Jupiter, Florida, 33458
Ardelyx Investigational Site
Lynchburg, Virginia, 24502
Ardelyx Investigational Site
Mission, Kansas, 66202
Ardelyx Investigational Site
Monroe, Louisiana, 71201
Ardelyx Investigational Site
Ogden, Utah, 84405
Ardelyx Investigational Site
Oklahoma City, Oklahoma, 73104
Ardelyx Investigational Site
Pinellas Park, Florida, 33782
Ardelyx Investigational Site
Rockford, Illinois, 61107
Ardelyx Investigational Site
San Diego, California, 92108
Ardelyx Investigational Site
Simpsonville, South Carolina, 29681
Ardelyx Investigational Site
St Louis, Missouri, 63128

Other trials in United States

About this study

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)

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.

Conditions: Constipation Predominant Irritable Bowel Syndrome
Being tested: RDX5791

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RDX5791Drug
Capsule, QD

Study groups in NCT01340053
Study group	Role	What they receive
Placebo	Placebo comparator	Capsule that is identical in size and color to other treatments Receives: Drug: RDX5791
Low Dose	Experimental	10 mg capsule of tenapanor Receives: Drug: RDX5791
Mid Dose	Experimental	30 mg capsule of tenapanor Receives: Drug: RDX5791
High Dose	Experimental	100 mg capsule of tenapanor Receives: Drug: RDX5791

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 4

Secondary outcomes (1)

Spontaneous Bowel Movement (SBM) Frequency Change From Baseline
Measured: baseline and week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Feb 2012

First posted22 Apr 2011 (estimated)
Study startMay 2011
Primary completionDec 2011
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Constipation Predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01340053
Sponsor's protocol ID: RDX5791-201
Status last verified: Sep 2019
First submitted: 20 Apr 2011
Last updated: 15 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Constipation Predominant Irritable Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01340053
Acronym / sponsor ID: RDX5791-201
Conditions: Constipation Predominant Irritable Bowel Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 186 participants (actual)
Lead sponsor: ArdelyxIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Dec 2011 (actual)
Study completion: Feb 2012 (actual)
First posted: 22 Apr 2011 (estimated)
Results: Posted 15 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: RDX5791Capsule that is identical in size and color to other treatments
Low Dose	Experimental	Drug: RDX579110 mg capsule of tenapanor
Mid Dose	Experimental	Drug: RDX579130 mg capsule of tenapanor
High Dose	Experimental	Drug: RDX5791100 mg capsule of tenapanor

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RDX5791Capsule, QD	Drug	High Dose, Low Dose, Mid Dose, Placebo

Primary outcome

Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline
Time frame: 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.

1 secondary outcome

Spontaneous Bowel Movement (SBM) Frequency Change From Baseline
Time frame: baseline and week 4

Results and safety

Results posted to the registry on 15 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	47	43
10mg	46	44
30 mg	47	43
100 mg	46	43

Primary outcome: Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline

Time frame: Baseline and Week 4. Mean (Standard Deviation). Unit: number of bowel movements/week

Measure	Placebo n = 47	Low Dose n = 45	Mid Dose n = 47	High Dose n = 46
Value	1.01 (2.03)	1.50 (2.09)	1.54 (2.10)	1.57 (2.50)

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

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 47 (0%)	0 of 47 (0%)	0 of 47
Low Dose	2 of 46 (4.3%)	0 of 46 (0%)	0 of 46
Mid Dose	0 of 47 (0%)	0 of 47 (0%)	0 of 47
High Dose	0 of 46 (0%)	0 of 46 (0%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David P Rosenbaum, Ph.D. study chair

Ardelyx

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RDX5791 in people with Constipation Predominant Irritable Bowel Syndrome, run by Ardelyx at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01340053.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.