AzTrials
AzTrials

Constipation Predominant Irritable Bowel SyndromePhase 3T3MPO-2NCT02686138

A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C

A Phase 3 study testing Tenapanor in people with Constipation Predominant Irritable Bowel Syndrome, run by Ardelyx at 117 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, 26-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of one dose 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… 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
593 participants
Where
117 sitesUnited States
Study dates
Dec 2015to Oct 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

  • Males or females aged 18 to 75 years, inclusive
  • 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 appropriate methods 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

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 or carcinoid syndrome.
  • Potential CNS cause of constipation (e.g., Parkinson's disease, spinal cord injury, or multiple sclerosis)
  • Subject has a history or current evidence of laxative abuse (in the clinical judgment of physician)
  • Hepatic dysfunction (ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal) or renal impairment (serum creatinine >2 mg/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 and cholecystectomy (unless within 60 days of screening visit)

Trial locations and contacts

117 sites in 1 country.

117 sites in 1 country

United States117 sites

  • Ardelyx Investigative Site 222

    Albuquerque, New Mexico, 87102

  • Ardelyx Investigative Site 264

    Albuquerque, New Mexico, 87106

  • Ardelyx Investigative Site 163

    Anaheim, California, 92801

  • Ardelyx Investigative Site 260

    Ann Arbor, Michigan, 48106

  • Ardelyx Investigative Site 160

    Annapolis, Maryland, 21401

  • Ardelyx Investigative Site 138

    Atlanta, Georgia, 30312

  • Ardelyx Investigative Site 148

    Atlanta, Georgia, 30342

  • Ardelyx Investigative Site 253

    Atlanta, Georgia, 30342

  • Ardelyx Investigative Site 271

    Bangor, Maine, 04401

  • Ardelyx Investigative Site 172

    Beavercreek, Ohio, 45432

  • Ardelyx Investigative Site 156

    Billings, Montana, 59102

  • Ardelyx Investigative Site 221

    Biloxi, Mississippi, 39531

  • Ardelyx Investigative Site 176

    Brandon, Florida, 33511

  • Ardelyx Investigative Site 212

    Bristol, Connecticut, 06010

  • Ardelyx Investigative Site 267

    Brockton, Massachusetts, 02302

  • Ardelyx Investigative Site 230

    Brooklyn, New York, 11206

  • Ardelyx Investigative Site 283

    Buckley, Michigan, 49620

  • Ardelyx Investigative Site 268

    Burr Ridge, Illinois, 60527

  • Ardelyx Investigative Site 105

    Canoga Park, California, 91303

  • Ardelyx Investigative Site 180

    Channelview, Texas, 77530

  • Ardelyx Investigative Site 217

    Chattanooga, Tennessee, 37404

  • Ardelyx Investigative Site 143

    Chula Vista, California, 91910

  • Ardelyx Investigative Site 204

    Cincinnati, Ohio, 45212

  • Ardelyx Investigative Site 201

    Cincinnati, Ohio, 45234

  • Ardelyx Investigative Site 252

    Columbia, South Carolina, 29204

  • Ardelyx Investigative Site 292

    Conway, Arkansas, 72034

  • Ardelyx Investigative Site 178

    Cutler Bay, Florida, 33157

  • Ardelyx Investigative Site 173

    Dayton, Ohio, 45429

  • Ardelyx Investigative Site 272

    Decatur, Georgia, 30032

  • Ardelyx Investigative Site 229

    Decatur, Georgia, 30033

  • Ardelyx Investigative Site 257

    Dothan, Alabama, 36305

  • Ardelyx Investigative Site 248

    East Providence, Rhode Island, 02914

  • Ardelyx Investigative Site 147

    Encino, California, 91436

  • Ardelyx Investigative Site 218

    Evansville, Indiana, 47714

  • Ardelyx Investigative Site 227

    Evergreen Park, Illinois, 60805

  • Ardelyx Investigative Site 205

    Fayetteville, North Carolina, 28304

  • Ardelyx Investigative Site 239

    Flint, Michigan, 48504

  • Ardelyx Investigative Site 200

    Foley, Alabama, 36535

  • Ardelyx Investigative Site 208

    Franklin, Ohio, 45005

  • Ardelyx Investigative Site 121

    Franklin, Tennessee, 37064

  • Ardelyx Investigative Site 265

    Gaffney, South Carolina, 29341

  • Ardelyx Investigative Site 170

    Great Neck, New York, 11023

  • Ardelyx Investigative Site 190

    Greensboro, North Carolina, 27408

  • Ardelyx Investigative Site 189

    Hermitage, Tennessee, 37076

  • Ardelyx Investigative Site 136

    Hialeah, Florida, 33012

  • Ardelyx Investigative Site 130

    Hialeah, Florida, 33016

  • Ardelyx Investigative Site 194

    Hickory, North Carolina, 28601

  • Ardelyx Investigative Site 291

    Hoffman Estates, Illinois, 60169

  • Ardelyx Investigative Site 286

    Houston, Texas, 77036

  • Ardelyx Investigative Site 262

    Houston, Texas, 77043

  • Ardelyx Investigative Site 185

    Houston, Texas, 77079

  • Ardelyx Investigative Site 171

    Huber Heights, Ohio, 45424

  • Ardelyx Investigative Site 103

    Huntsville, Alabama, 35801

  • Ardelyx Investigative Site 244

    Huntsville, Alabama, 35801

  • Ardelyx Investigative Site 251

    Huntsville, Alabama, 35801

  • Ardelyx Investigative Site 100

    Huntsville, Alabama, 35802

  • Ardelyx Investigative Site 133

    Jackson, Tennessee, 38305

  • Ardelyx Investigative Site 282

    Jefferson City, Missouri, 65109

  • Ardelyx Investigative Site 109

    Knoxville, Tennessee, 37909

  • Ardelyx Investigative Site 297

    La Mesa, California, 91942

  • Ardelyx Investigative Site 284

    La Mirada, California, 90638

  • Ardelyx Investigative Site 182

    Las Vegas, Nevada, 89128

  • Ardelyx Investigative Site 220

    Levittown, Pennsylvania, 19056

  • Ardelyx Investigative Site 219

    Lima, Ohio, 45806

  • Ardelyx Investigative Site 122

    Little Rock, Arkansas, 72212

  • Ardelyx Investigative Site 107

    Lomita, California, 90717

  • Ardelyx Investigative Site 165

    Long Beach, California, 90807

  • Ardelyx Investigative Site 191

    Lynn Haven, Florida, 32444

  • Ardelyx Investigative Site 158

    Madisonville, Kentucky, 42431

  • Ardelyx Investigative Site 270

    Mandeville, Louisiana, 70471

  • Ardelyx Investigative Site 250

    Marietta, Georgia, 30060

  • Ardelyx Investigative Site 214

    Marrero, Louisiana, 70072

  • Ardelyx Investigative Site 113

    McKinney, Texas, 75071

  • Ardelyx Investigative Site 266

    Memphis, Tennessee, 38119

  • Ardelyx Investigative Site 154

    Metairie, Louisiana, 70006

  • Ardelyx Investigative Site 288

    Miami, Florida, 33144

  • Ardelyx Investigative Site 106

    Miami, Florida, 33186

  • Ardelyx Investigative Site 127

    Miami Lakes, Florida, 33014

  • Ardelyx Investigative Site 195

    Morgantown, West Virginia, 26505

  • Ardelyx Investigative Site 235

    Nashville, Tennessee, 37211

  • Ardelyx Investigative Site 203

    New Hyde Park, New York, 11040

  • Ardelyx Investigative Site 137

    Norcross, Georgia, 30071

  • Ardelyx Investigative Site 249

    Norfolk, Virginia, 23502

  • Ardelyx Investigative Site 231

    Norfolk, Virginia, 23507

  • Ardelyx Investigative Site 202

    Oak Lawn, Illinois, 60453

  • Ardelyx Investigative Site 236

    Oklahoma City, Oklahoma, 73103

  • Ardelyx Investigative Site 211

    Orange, California, 92868

  • Ardelyx Investigative Site 179

    Orlando, Florida, 32803

  • Ardelyx Investigative Site 258

    Petersburg, Virginia, 23805

  • Ardelyx Investigative Site 210

    Phoenix, Arizona, 85018

  • Ardelyx Investigative Site 296

    Phoenix, Arizona, 85018

  • Ardelyx Investigative Site 263

    Port Arthur, Texas, 77640

  • Ardelyx Investigative Site 246

    Rapid City, South Dakota, 57702

  • Ardelyx Investigative Site 167

    Salt Lake City, Utah, 84102

  • Ardelyx Investigative Site 181

    San Antonio, Texas, 78229

  • Ardelyx Investigative Site 186

    San Antonio, Texas, 78258

  • Ardelyx Investigative Site 209

    Saraland, Alabama, 36571

  • Ardelyx Investigative Site 213

    Savannah, Georgia, 31406

  • Ardelyx Investigative Site 195

    Shreveport, Louisiana, 71103

  • Ardelyx Investigative Site 261

    Sioux Falls, South Dakota, 57108

  • Ardelyx Investigative Site 124

    Snellville, Georgia, 30078

  • Ardelyx Investigative Site 242

    Spokane, Washington, 99202

  • Ardelyx Investigative Site 279

    Spring Hill, Tennessee, 37174

  • Ardelyx Investigative Site 228

    St Louis, Missouri, 63042

  • Ardelyx Investigative Site 290

    Tampa, Florida, 33607

  • Ardelyx Investigative Site 255

    Towson, Maryland, 21204

  • Ardelyx Investigative Site 168

    Troy, Michigan, 48098

  • Ardelyx Investigative Site 269

    Tucson, Arizona, 85704

  • Ardelyx Investigative Site 256

    Tucson, Arizona, 85710

  • Ardelyx Investigative Site 273

    Tulsa, Oklahoma, 74135

  • Ardelyx Investigative Site 175

    Vineland, New Jersey, 08360

  • Ardelyx Investigative Site 245

    Virginia Beach, Virginia, 23462

  • Ardelyx Investigative Site 232

    Wadsworth, Ohio, 44281

  • Ardelyx Investigative Site 254

    West Palm Beach, Florida, 33409

  • Ardelyx Investigative Site 233

    Wheat Ridge, Colorado, 80033

  • Ardelyx Investigative Site 285

    Wilmington, North Carolina, 28401

  • Ardelyx Investigative Site 216

    Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: A 26-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

This phase 3, 26-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of one dose 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 (1:1) for a 26 week treatment period.

Read the detailed description

During the 26-week double-blind treatment period, subjects will record daily assessments including: frequency and timing of bowel movements; sensation of complete bowel emptying; consistency of bowel movements; degree of straining, worst abdominal pain, abdominal discomfort, abdominal bloating, abdominal fullness and abdominal cramping; and use and timing of rescue medication. Subjects will also record weekly assessments including: adequate relief of IBS symptoms, degree of relief of IBS symptoms, IBS severity, and constipation severity.

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 NCT02686138
Study groupRoleWhat they receive
50mg BIDExperimentalTenapanor, 50mg BID (100mg total)
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. Percentage of Subjects With Overall Response for 6 Out of 12 Weeks

    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: First 12 weeks

Secondary outcomes (8)

  1. Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 12 Weeks

    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: First 12 weeks

  2. Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 12 Weeks

    An overall abdominal pain responder is defined as a weekly responder for the first 6/12 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: First 12 weeks

  3. Percentage of Subjects With Overall Response for 13 Out of 26 Weeks

    An overall responder is defined as a weekly responder for the first 13/26 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: 26 weeks

  4. Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks

    An overall CSBM responder is defined as a weekly responder for the first 13/26 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: 26 weeks

  5. Percentage of Subjects With Overall Abdominal Pain Response for 13 Out of 26 Weeks

    An overall abdominal pain responder is defined as a weekly responder for the first 13/26 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: 26 weeks

  6. Percentage of Subjects With Overall Response for 9 Out of 12 Weeks

    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: First 12 weeks

  7. Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 9 Out of 12 Weeks

    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: First 12 weeks

  8. Percentage of Subjects With Overall Abdominal Pain Response for 9 Out of 12 Weeks

    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: First 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 posted19 Feb 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionAug 2017
  4. Study completionOct 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
593 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02686138
Sponsor's protocol ID
TEN-01-302
Acronym
T3MPO-2
Status last verified
Apr 2020
First submitted
11 Jan 2016
Last updated
22 Apr 2020
Data monitoring committee
No
Individual data sharing
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

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 117 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 8 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 22 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 117 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 13 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?

Percentage of Subjects With Overall Response for 6 Out of 12 Weeks (time frame: First 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 NCT02686138, which also lists 3 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 22 Apr 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in