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Constipation Predominant Irritable Bowel SyndromePhase 3T3MPO-1NCT02621892

A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-C

A Phase 3 study testing Tenapanor in people with Constipation Predominant Irritable Bowel Syndrome, run by Ardelyx at 111 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

This phase 3, 12-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of tenapanor in subjects with constipation-predominant irritable bowel syndrome (IBS-C) as defined by the ROME III criteria and who have active disease as determined after a two-week screening… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Tenapanor
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
606 participants
Where
111 sitesUnited States
Study dates
Oct 2015to Apr 2017
Phase
Phase 3
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

  • 18 to 75 years old
  • Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception.
  • Males must agree to use an appropriate method of barrier contraception or have documented surgical sterilization
  • Subject meets definition of IBS-C using Rome III Criteria for the Diagnosis of IBS
  • A colonoscopy based on AGA guidelines; every 10 years at ≥ 50 years old, or the occurrence of any warning signs

Who cannot join

  • Functional diarrhea as defined by Rome III criteria
  • IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome III criteria
  • Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening; including but not limited to cancer, inflammatory bowel disease, diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, pancreatitis (within 12 months of screening), cholelithiasis, amyloidosis, ileus, non-controlled GERD, gastrointestinal obstruction, ischemic colitis or carcinoid syndrome.
  • Subject has a history or current evidence of laxative abuse (in the clinical judgment of the physician)
  • Hepatic dysfunction (ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal) or renal impairment (serum creatinine > 2mg/dL)
  • Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous year
  • Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy (unless within 60 days of screening visit)

Trial locations and contacts

111 sites in 1 country.

111 sites in 1 country

United States111 sites

  • Ardelyx Investigative Site 293

    Albuquerque, New Mexico, 87108

  • Ardelyx Investigative Site 226

    Asheville, North Carolina, 28801

  • Ardelyx Investigative Site 234

    Athens, Georgia, 30607

  • Ardelyx Investigative Site 138

    Atlanta, Georgia, 30312

  • Ardelyx Investigative Site 148

    Atlanta, Georgia, 30342

  • Ardelyx Investigative Site 172

    Beavercreek, Ohio, 45432

  • Ardelyx Investigative Site 125

    Belton, Missouri, 64012

  • Ardelyx Investigative Site 156

    Billings, Montana, 59102

  • Ardelyx Investigative Site 149

    Birmingham, Alabama, 35216

  • Ardelyx Investigative Site 114

    Birmingham, Alabama, 35242

  • Ardelyx Investigative Site 102

    Blue Island, Illinois, 60406

  • Ardelyx Investigative Site 157

    Boise, Idaho, 83642

  • Ardelyx Investigative Site 135

    Boston, Massachusetts, 02131

  • Ardelyx Investigative Site 267

    Brockton, Massachusetts, 02302

  • Ardelyx Investigative Site 151

    Brooklyn, New York, 11215

  • Ardelyx Investigative Site 105

    Canoga Park, California, 91303

  • Ardelyx Investigative Site 119

    Caro, Michigan, 48723

  • Ardelyx Investigative Site 145

    Chandler, Arizona, 85224

  • Ardelyx Investigative Site 166

    Charlotte, North Carolina, 28210

  • Ardelyx Investigative Site 134

    Chattanooga, Tennessee, 37421

  • Ardelyx Investigative Site 128

    Chesterfield, Michigan, 48047

  • Ardelyx Investigative Site 143

    Chula Vista, California, 91910

  • Ardelyx Investigative Site 223

    Cincinnati, Ohio, 45219

  • Ardelyx Investigative Site 201

    Cincinnati, Ohio, 45234

  • Ardelyx Investigative Site 139

    Columbus, Ohio, 43214

  • Ardelyx Investigative Site 164

    Corpus Christi, Texas, 78413

  • Ardelyx Investigative Site 197

    Corsicana, Texas, 75110

  • Ardelyx Investigative Site 192

    Crowley, Louisiana, 70526

  • Ardelyx Investigative Site 178

    Cutler Bay, Florida, 33157

  • Ardelyx Investigative Site 173

    Dayton, Ohio, 45429

  • Ardelyx Investigative Site 146

    Encino, California, 91436

  • Ardelyx Investigative Site 147

    Encino, California, 91436

  • Ardelyx Investigative Site 162

    Evanston, Illinois, 60201

  • Ardelyx Investigative Site 205

    Fayetteville, North Carolina, 28304

  • Ardelyx Investigative Site 131

    Fort Lauderdale, Florida, 33308

  • Ardelyx Investigative Site 121

    Franklin, Tennessee, 37064

  • Ardelyx Investigative Site 170

    Great Neck, New York, 11023

  • Ardelyx Investigative Site 104

    Greensboro, North Carolina, 27403

  • Ardelyx Investigative Site 278

    Hagerstown, Maryland, 21742

  • Ardelyx Investigative Site 140

    Harrisburg, Arkansas, 72432

  • Ardelyx Investigative Site 225

    Hartsdale, New York, 10530

  • Ardelyx Investigative Site 189

    Hermitage, Tennessee, 37076

  • Ardelyx Investigative Site 136

    Hialeah, Florida, 33012

  • Ardelyx Investigative Site 130

    Hialeah, Florida, 33016

  • Ardelyx Investigative Site 287

    Homestead, Florida, 33030

  • Ardelyx Investigative Site 185

    Houston, Texas, 77079

  • Ardelyx Investigative Site 120

    Houston, Texas, 77090

  • Ardelyx Investigative Site 171

    Huber Heights, Ohio, 45424

  • Ardelyx Investigative Site 103

    Huntsville, Alabama, 35801

  • Ardelyx Investigative Site 100

    Huntsville, Alabama, 35802

  • Ardelyx Investigative Site 133

    Jackson, Tennessee, 38305

  • Ardelyx Investigative Site 144

    Jenkintown, Pennsylvania, 19046

  • Ardelyx Investigative Site 174

    Kinston, North Carolina, 28501

  • Ardelyx Investigative Site 109

    Knoxville, Tennessee, 37909

  • Ardelyx Investigative Site 275

    Las Vegas, Nevada, 89103

  • Ardelyx Investigative Site 276

    Las Vegas, Nevada, 89119

  • Ardelyx Investigative Site 182

    Las Vegas, Nevada, 89128

  • Ardelyx Investigative Site 274

    Little Rock, Arkansas, 72209

  • Ardelyx Investigative Site 161

    Little Rock, Arkansas, 72211

  • Ardelyx Investigative Site 122

    Little Rock, Arkansas, 72212

  • Ardelyx Investigative Site 107

    Lomita, California, 90717

  • Ardelyx Investigative Site 113

    McKinney, Texas, 75071

  • Ardelyx Investigative Site 117

    Mentor, Ohio, 44060

  • Ardelyx Investigative Site 188

    Metairie, Louisiana, 70006

  • Ardelyx Investigative Site 106

    Miami, Florida, 33186

  • Ardelyx Investigative Site 127

    Miami Lakes, Florida, 33014

  • Ardelyx Investigative Site 123

    Miami Springs, Florida, 33166

  • Ardelyx Investigative Site 177

    Monroe, Louisiana, 71201

  • Ardelyx Investigative Site 289

    Mt. Pleasant, South Carolina, 29464

  • Ardelyx Investigative Site 184

    Myrtle Beach, South Carolina, 29588

  • Ardelyx Investigative Site 235

    Nashville, Tennessee, 37211

  • Ardelyx Investigative Site 206

    New Windsor, New York, 12553

  • Ardelyx Investigative Site 183

    New York, New York, 10036

  • Ardelyx Investigative Site 137

    Norcross, Georgia, 30071

  • Ardelyx Investigative Site 231

    Norfolk, Virginia, 23507

  • Ardelyx Investigative Site 281

    North Charleston, South Carolina, 29406

  • Ardelyx Investigative Site 112

    North Hollywood, California, 91606

  • Ardelyx Investigative Site 129

    North Little Rock, Arkansas, 72117

  • Ardelyx Investigative Site 110

    Northridge, California, 91325

  • Ardelyx Investigative Site 202

    Oak Lawn, Illinois, 60453

  • Ardelyx Investigative Site 142

    Omaha, Nebraska, 68114

  • Ardelyx Investigative Site 159

    Orem, Utah, 84058

  • Ardelyx Investigative Site 210

    Phoenix, Arizona, 85018

  • Ardelyx Investigative Site 296

    Phoenix, Arizona, 85018

  • Ardelyx Investigative Site 111

    Plano, Texas, 75093

  • Ardelyx Investigative Site 118

    Plano, Texas, 75093

  • Ardelyx Investigative Site 126

    Pompano Beach, Florida, 33060

  • Ardelyx Investigative Site 132

    Port Orange, Florida, 32129

  • Ardelyx Investigative Site 141

    Richmond, Virginia, 23294

  • Ardelyx Investigative Site 224

    Saginaw, Michigan, 48604

  • Ardelyx Investigative Site 101

    San Antonio, Texas, 78215

  • Ardelyx Investigative Site 240

    San Antonio, Texas, 78229

  • Ardelyx Investigative Site 294

    San Diego, California, 92123

  • Ardelyx Investigative Site 207

    Sandy City, Utah, 84094

  • Ardelyx Investigative Site 213

    Savannah, Georgia, 31406

  • Ardelyx Investigative Site 261

    Sioux Falls, South Dakota, 57108

  • Ardelyx Investigative Site 124

    Snellville, Georgia, 30078

  • Ardelyx Investigative Site 155

    South Ogden, Utah, 84405

  • Ardelyx Investigative Site 247

    Springfield, Ohio, 45504

  • Ardelyx Investigative Site 150

    St. Petersburg, Florida, 33709

  • Ardelyx Investigative Site 277

    Tempe, Arizona, 85283

  • Ardelyx Investigative Site 108

    Thousand Oaks, California, 91360

  • Ardelyx Investigative Site 259

    Topeka, Kansas, 66606

  • Ardelyx Investigative Site 255

    Towson, Maryland, 21204

  • Ardelyx Investigative Site 269

    Tucson, Arizona, 85704

  • Ardelyx Investigative Site 187

    Tucson, Arizona, 85712

  • Ardelyx Investigative Site 199

    Tucson, Arizona, 85741

  • Ardelyx Investigative Site 175

    Vineland, New Jersey, 08360

  • Ardelyx Investigative Site 254

    West Palm Beach, Florida, 33409

  • Ardelyx Investigative Site 280

    Winston-Salem, North Carolina, 27103

  • Ardelyx Investigative Site 198

    Zachary, Louisiana, 70791

Other trials in United States

About this study

Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

This phase 3, 12-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of tenapanor in subjects with constipation-predominant irritable bowel syndrome (IBS-C) as defined by the ROME III criteria and who have active disease as determined after a two-week screening period. Subjects who qualify and are randomized into the study will either receive 50mg BID of tenapanor or placebo BID for 12 week treatment period and then undergo a 4 week placebo controlled randomized withdrawal.

Read the detailed description

During the 12-week treatment period, subjects will record daily assessments including: frequency and timing of bowel movements; sensation and complete bowel emptying; consistency of bowel movements; degree of straining, worst abdominal pain, abdominal discomfort, abdominal bloating, abdominal fullness and abdominal cramping. Subjects will also record weekly assessments including: adequate relief of IBS severity, and constipation severity.

At the end of the 12-week treatment period, there will be a 4-week randomized withdrawal period in which subjects who complete the study in Tenapanor group will be randomized to either Tenapanor 50mg BID or placebo BID (1:1) and subjects who complete the study in the placebo group will be assigned to receive Tenapanor 50mg BID.

Being tested
Tenapanor, Placebo

What participants receive

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

  • TenapanorDrug

    Also called RDX5791, AZD1722

  • PlaceboDrug

Study groups in NCT02621892
Study groupRoleWhat they receive
50mg BIDExperimentalTenapanor
Receives: Drug: Tenapanor
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

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

  1. 6 of 12 Week Overall Responder Rate

    An overall responder is defined as a weekly responder for the first 6/12 weeks where both CSBM and abdominal pain response criteria were met for the week. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?" The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.

    Measured: 12 weeks

Secondary outcomes (5)

  1. 6 of 12 Week Overall Complete Spontaneous Bowel Movement (CSBM)Responder Rate

    An overall CSBM responder is defined as a weekly responder for the first 6/12 weeks. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?"

    Measured: 12 weeks

  2. 6 of 12 Week Overall Abdominal Pain Responder Rate

    An overall abdominal pain responder is defined as a weekly responder for the first 6/12. The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.

    Measured: 12 weeks

  3. 9 of 12 Week Overall Responder Rate

    An overall responder is defined as a weekly responder for the first 9/12 weeks where both CSBM and abdominal pain response criteria were met for the week. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline and a minimum of at least 3 CSBMs that same week. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?" The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.

    Measured: 12 weeks

  4. 9 of 12 Week Overall CSBM Responder Rate

    An overall CSBM responder is defined as a weekly responder for the first 9/12 weeks. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline and a minimum of at least 3 CSBMs that same week. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds "yes" to the following question; "Did you feel like you completely emptied your bowels?"

    Measured: 12 weeks

  5. 9 of 12 Week Overall Abdominal Pain Responder Rate

    An overall abdominal pain responder is defined as a weekly responder for the first 9/12 weeks. The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.

    Measured: 12 weeks

Timeline

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

  1. First posted4 Dec 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionMar 2017
  4. Study completionApr 2017

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
606 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02621892
Sponsor's protocol ID
TEN-01-301
Acronym
T3MPO-1
Status last verified
Apr 2020
First submitted
2 Dec 2015
Last updated
21 Apr 2020
Data monitoring committee
No

Publications

  • Lacy BE, Shin AS, Cangemi DJ, Yang Y, Zhao S, Rosenbaum DP. Tenapanor is associated with earlier and sustained symptom relief in IBS-C: a post hoc analysis. Ther Adv Gastroenterol. 2026 Jan 24;19:17562848251414831. doi: 10.1177/17562848251414831. eCollection 2026.

    PubMed 41601848

  • Lembo AJ, Friedenberg KA, Fogel RP, Edelstein S, Zhao S, Yang Y, Rosenbaum DP, Chey WD. Long-term safety of tenapanor in patients with irritable bowel syndrome with constipation in the T3MPO-3 study. Neurogastroenterol Motil. 2023 Nov;35(11):e14658. doi: 10.1111/nmo.14658. Epub 2023 Sep 5.

    PubMed 37668173

  • Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2). Am J Gastroenterol. 2021 Jun 1;116(6):1294-1303. doi: 10.14309/ajg.0000000000001056.

    PubMed 33337659

  • Chey WD, Lembo AJ, Rosenbaum DP. Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1). Am J Gastroenterol. 2020 Feb;115(2):281-293. doi: 10.14309/ajg.0000000000000516.

    PubMed 31934897

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tenapanor in people with Constipation Predominant Irritable Bowel Syndrome, run by Ardelyx at 111 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 7 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 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 21 Apr 2020). 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?

6 of 12 Week Overall Responder Rate (time frame: 12 weeks). 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 NCT02621892, which also lists 4 linked publications.

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 21 Apr 2020.

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