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

NCT02621892 | Completed Phase 3 Results

• 1 other identifier: TEN-01-301
• Study Type: interventional
• Target: 606
• Locations: 1 country
• Sites: 111

Brief 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 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.

Conditions

Constipation Predominant Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (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.

  12 weeks

Secondary Outcomes (5)

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

  12 weeks

• 6 of 12 Week Overall Abdominal Pain Responder Rate

  12 weeks

• 9 of 12 Week Overall Responder Rate

  12 weeks

• 9 of 12 Week Overall CSBM Responder Rate

  12 weeks

• 9 of 12 Week Overall Abdominal Pain Responder Rate

  12 weeks

Study Arms (2)

50mg BID

EXPERIMENTAL

Tenapanor

Drug: Tenapanor

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Tenapanor DRUG

Also known as: RDX5791, AZD1722

50mg BID

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ardelyx: lead

Study Sites (111)

Ardelyx Investigative Site 149

Birmingham, Alabama, 35216, United States

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Ardelyx Investigative Site 114

Birmingham, Alabama, 35242, United States

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Ardelyx Investigative Site 103

Huntsville, Alabama, 35801, United States

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Ardelyx Investigative Site 100

Huntsville, Alabama, 35802, United States

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Ardelyx Investigative Site 145

Chandler, Arizona, 85224, United States

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Ardelyx Investigative Site 210

Phoenix, Arizona, 85018, United States

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Ardelyx Investigative Site 296

Phoenix, Arizona, 85018, United States

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Ardelyx Investigative Site 277

Tempe, Arizona, 85283, United States

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Ardelyx Investigative Site 269

Tucson, Arizona, 85704, United States

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Ardelyx Investigative Site 187

Tucson, Arizona, 85712, United States

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Ardelyx Investigative Site 199

Tucson, Arizona, 85741, United States

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Ardelyx Investigative Site 140

Harrisburg, Arkansas, 72432, United States

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Ardelyx Investigative Site 274

Little Rock, Arkansas, 72209, United States

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Ardelyx Investigative Site 161

Little Rock, Arkansas, 72211, United States

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Ardelyx Investigative Site 122

Little Rock, Arkansas, 72212, United States

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Ardelyx Investigative Site 129

North Little Rock, Arkansas, 72117, United States

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Ardelyx Investigative Site 105

Canoga Park, California, 91303, United States

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Ardelyx Investigative Site 143

Chula Vista, California, 91910, United States

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Ardelyx Investigative Site 146

Encino, California, 91436, United States

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Ardelyx Investigative Site 147

Encino, California, 91436, United States

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Ardelyx Investigative Site 107

Lomita, California, 90717, United States

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Ardelyx Investigative Site 112

North Hollywood, California, 91606, United States

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Ardelyx Investigative Site 110

Northridge, California, 91325, United States

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Ardelyx Investigative Site 294

San Diego, California, 92123, United States

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Ardelyx Investigative Site 108

Thousand Oaks, California, 91360, United States

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Ardelyx Investigative Site 178

Cutler Bay, Florida, 33157, United States

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Ardelyx Investigative Site 131

Fort Lauderdale, Florida, 33308, United States

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Ardelyx Investigative Site 136

Hialeah, Florida, 33012, United States

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Ardelyx Investigative Site 130

Hialeah, Florida, 33016, United States

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Ardelyx Investigative Site 287

Homestead, Florida, 33030, United States

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Ardelyx Investigative Site 106

Miami, Florida, 33186, United States

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Ardelyx Investigative Site 127

Miami Lakes, Florida, 33014, United States

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Ardelyx Investigative Site 123

Miami Springs, Florida, 33166, United States

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Ardelyx Investigative Site 126

Pompano Beach, Florida, 33060, United States

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Ardelyx Investigative Site 132

Port Orange, Florida, 32129, United States

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Ardelyx Investigative Site 150

St. Petersburg, Florida, 33709, United States

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Ardelyx Investigative Site 254

West Palm Beach, Florida, 33409, United States

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Ardelyx Investigative Site 234

Athens, Georgia, 30607, United States

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Ardelyx Investigative Site 138

Atlanta, Georgia, 30312, United States

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Ardelyx Investigative Site 148

Atlanta, Georgia, 30342, United States

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Ardelyx Investigative Site 137

Norcross, Georgia, 30071, United States

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Ardelyx Investigative Site 213

Savannah, Georgia, 31406, United States

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Ardelyx Investigative Site 124

Snellville, Georgia, 30078, United States

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Ardelyx Investigative Site 157

Boise, Idaho, 83642, United States

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Ardelyx Investigative Site 102

Blue Island, Illinois, 60406, United States

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Ardelyx Investigative Site 162

Evanston, Illinois, 60201, United States

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Ardelyx Investigative Site 202

Oak Lawn, Illinois, 60453, United States

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Ardelyx Investigative Site 259

Topeka, Kansas, 66606, United States

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Ardelyx Investigative Site 192

Crowley, Louisiana, 70526, United States

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Ardelyx Investigative Site 188

Metairie, Louisiana, 70006, United States

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Ardelyx Investigative Site 177

Monroe, Louisiana, 71201, United States

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Ardelyx Investigative Site 198

Zachary, Louisiana, 70791, United States

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Ardelyx Investigative Site 278

Hagerstown, Maryland, 21742, United States

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Ardelyx Investigative Site 255

Towson, Maryland, 21204, United States

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Ardelyx Investigative Site 135

Boston, Massachusetts, 02131, United States

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Ardelyx Investigative Site 267

Brockton, Massachusetts, 02302, United States

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Ardelyx Investigative Site 119

Caro, Michigan, 48723, United States

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Ardelyx Investigative Site 128

Chesterfield, Michigan, 48047, United States

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Ardelyx Investigative Site 224

Saginaw, Michigan, 48604, United States

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Ardelyx Investigative Site 125

Belton, Missouri, 64012, United States

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Ardelyx Investigative Site 156

Billings, Montana, 59102, United States

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Ardelyx Investigative Site 142

Omaha, Nebraska, 68114, United States

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Ardelyx Investigative Site 275

Las Vegas, Nevada, 89103, United States

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Ardelyx Investigative Site 276

Las Vegas, Nevada, 89119, United States

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Ardelyx Investigative Site 182

Las Vegas, Nevada, 89128, United States

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Ardelyx Investigative Site 175

Vineland, New Jersey, 08360, United States

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Ardelyx Investigative Site 293

Albuquerque, New Mexico, 87108, United States

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Ardelyx Investigative Site 151

Brooklyn, New York, 11215, United States

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Ardelyx Investigative Site 170

Great Neck, New York, 11023, United States

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Ardelyx Investigative Site 225

Hartsdale, New York, 10530, United States

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Ardelyx Investigative Site 206

New Windsor, New York, 12553, United States

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Ardelyx Investigative Site 183

New York, New York, 10036, United States

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Ardelyx Investigative Site 226

Asheville, North Carolina, 28801, United States

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Ardelyx Investigative Site 166

Charlotte, North Carolina, 28210, United States

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Ardelyx Investigative Site 205

Fayetteville, North Carolina, 28304, United States

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Ardelyx Investigative Site 104

Greensboro, North Carolina, 27403, United States

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Ardelyx Investigative Site 174

Kinston, North Carolina, 28501, United States

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Ardelyx Investigative Site 280

Winston-Salem, North Carolina, 27103, United States

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Ardelyx Investigative Site 172

Beavercreek, Ohio, 45432, United States

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Ardelyx Investigative Site 223

Cincinnati, Ohio, 45219, United States

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Ardelyx Investigative Site 201

Cincinnati, Ohio, 45234, United States

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Ardelyx Investigative Site 139

Columbus, Ohio, 43214, United States

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Ardelyx Investigative Site 173

Dayton, Ohio, 45429, United States

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Ardelyx Investigative Site 171

Huber Heights, Ohio, 45424, United States

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Ardelyx Investigative Site 117

Mentor, Ohio, 44060, United States

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Ardelyx Investigative Site 247

Springfield, Ohio, 45504, United States

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Ardelyx Investigative Site 144

Jenkintown, Pennsylvania, 19046, United States

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Ardelyx Investigative Site 289

Mt. Pleasant, South Carolina, 29464, United States

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Ardelyx Investigative Site 184

Myrtle Beach, South Carolina, 29588, United States

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Ardelyx Investigative Site 281

North Charleston, South Carolina, 29406, United States

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Ardelyx Investigative Site 261

Sioux Falls, South Dakota, 57108, United States

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Ardelyx Investigative Site 134

Chattanooga, Tennessee, 37421, United States

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Ardelyx Investigative Site 121

Franklin, Tennessee, 37064, United States

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Ardelyx Investigative Site 189

Hermitage, Tennessee, 37076, United States

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Ardelyx Investigative Site 133

Jackson, Tennessee, 38305, United States

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Ardelyx Investigative Site 109

Knoxville, Tennessee, 37909, United States

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Ardelyx Investigative Site 235

Nashville, Tennessee, 37211, United States

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Ardelyx Investigative Site 164

Corpus Christi, Texas, 78413, United States

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Ardelyx Investigative Site 197

Corsicana, Texas, 75110, United States

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Ardelyx Investigative Site 185

Houston, Texas, 77079, United States

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Ardelyx Investigative Site 120

Houston, Texas, 77090, United States

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Ardelyx Investigative Site 113

McKinney, Texas, 75071, United States

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Ardelyx Investigative Site 111

Plano, Texas, 75093, United States

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Ardelyx Investigative Site 118

Plano, Texas, 75093, United States

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Ardelyx Investigative Site 101

San Antonio, Texas, 78215, United States

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Ardelyx Investigative Site 240

San Antonio, Texas, 78229, United States

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Ardelyx Investigative Site 159

Orem, Utah, 84058, United States

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Ardelyx Investigative Site 207

Sandy City, Utah, 84094, United States

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Ardelyx Investigative Site 155

South Ogden, Utah, 84405, United States

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Ardelyx Investigative Site 231

Norfolk, Virginia, 23507, United States

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Ardelyx Investigative Site 141

Richmond, Virginia, 23294, United States

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Related Publications (4)

• 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. Therap Adv Gastroenterol. 2026 Jan 24;19:17562848251414831. doi: 10.1177/17562848251414831. eCollection 2026.

  PMID: 41601848 DERIVED

• 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.

  PMID: 37668173 DERIVED

• 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.

  PMID: 33337659 DERIVED

• 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.

  PMID: 31934897 DERIVED

MeSH Terms

Interventions

tenapanor

Results Point of Contact

• Title: Chief Development Officer
• Organization: Ardelyx

drosenbaum@ardelyx.com

6175134929

Study Officials

• David P Rosenbaum, Ph.D.

  Ardelyx, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 4, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 21, 2020
• Results First Posted: April 21, 2020

Record last verified: 2020-04

Locations

US (111)