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

NCT02686138 | Completed Phase 3 Results

• 1 other identifier: TEN-01-302
• Study Type: interventional
• Target: 593
• Locations: 1 country
• Sites: 117

Brief 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 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.

Conditions

Constipation Predominant Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (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.

  First 12 weeks

Secondary Outcomes (8)

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

  First 12 weeks

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

  First 12 weeks

• Percentage of Subjects With Overall Response for 13 Out of 26 Weeks

  26 weeks

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

  26 weeks

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

  26 weeks

Study Arms (2)

50mg BID

EXPERIMENTAL

Tenapanor, 50mg BID (100mg total)

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:

• 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

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 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)

Sponsors & Collaborators

• Ardelyx: lead

Study Sites (117)

Ardelyx Investigative Site 257

Dothan, Alabama, 36305, United States

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Ardelyx Investigative Site 200

Foley, Alabama, 36535, United States

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Ardelyx Investigative Site 103

Huntsville, Alabama, 35801, United States

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Ardelyx Investigative Site 244

Huntsville, Alabama, 35801, United States

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Ardelyx Investigative Site 251

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 209

Saraland, Alabama, 36571, 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 269

Tucson, Arizona, 85704, United States

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Ardelyx Investigative Site 256

Tucson, Arizona, 85710, United States

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Ardelyx Investigative Site 292

Conway, Arkansas, 72034, United States

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Ardelyx Investigative Site 122

Little Rock, Arkansas, 72212, United States

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Ardelyx Investigative Site 163

Anaheim, California, 92801, 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 147

Encino, California, 91436, United States

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Ardelyx Investigative Site 297

La Mesa, California, 91942, United States

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Ardelyx Investigative Site 284

La Mirada, California, 90638, United States

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Ardelyx Investigative Site 107

Lomita, California, 90717, United States

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Ardelyx Investigative Site 165

Long Beach, California, 90807, United States

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Ardelyx Investigative Site 211

Orange, California, 92868, United States

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Ardelyx Investigative Site 233

Wheat Ridge, Colorado, 80033, United States

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Ardelyx Investigative Site 212

Bristol, Connecticut, 06010, United States

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Ardelyx Investigative Site 176

Brandon, Florida, 33511, United States

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Ardelyx Investigative Site 178

Cutler Bay, Florida, 33157, 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 191

Lynn Haven, Florida, 32444, United States

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Ardelyx Investigative Site 288

Miami, Florida, 33144, 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 179

Orlando, Florida, 32803, United States

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Ardelyx Investigative Site 290

Tampa, Florida, 33607, United States

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Ardelyx Investigative Site 254

West Palm Beach, Florida, 33409, 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 253

Atlanta, Georgia, 30342, United States

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Ardelyx Investigative Site 272

Decatur, Georgia, 30032, United States

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Ardelyx Investigative Site 229

Decatur, Georgia, 30033, United States

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Ardelyx Investigative Site 250

Marietta, Georgia, 30060, 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 268

Burr Ridge, Illinois, 60527, United States

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Ardelyx Investigative Site 227

Evergreen Park, Illinois, 60805, United States

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Ardelyx Investigative Site 291

Hoffman Estates, Illinois, 60169, United States

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Ardelyx Investigative Site 202

Oak Lawn, Illinois, 60453, United States

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Ardelyx Investigative Site 218

Evansville, Indiana, 47714, United States

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Ardelyx Investigative Site 158

Madisonville, Kentucky, 42431, United States

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Ardelyx Investigative Site 270

Mandeville, Louisiana, 70471, United States

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Ardelyx Investigative Site 214

Marrero, Louisiana, 70072, United States

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Ardelyx Investigative Site 154

Metairie, Louisiana, 70006, United States

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Ardelyx Investigative Site 195

Shreveport, Louisiana, 71103, United States

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Ardelyx Investigative Site 271

Bangor, Maine, 04401, United States

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Ardelyx Investigative Site 160

Annapolis, Maryland, 21401, United States

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Ardelyx Investigative Site 255

Towson, Maryland, 21204, United States

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Ardelyx Investigative Site 267

Brockton, Massachusetts, 02302, United States

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Ardelyx Investigative Site 260

Ann Arbor, Michigan, 48106, United States

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Ardelyx Investigative Site 283

Buckley, Michigan, 49620, United States

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Ardelyx Investigative Site 239

Flint, Michigan, 48504, United States

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Ardelyx Investigative Site 168

Troy, Michigan, 48098, United States

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Ardelyx Investigative Site 216

Wyoming, Michigan, 49519, United States

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Ardelyx Investigative Site 221

Biloxi, Mississippi, 39531, United States

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Ardelyx Investigative Site 282

Jefferson City, Missouri, 65109, United States

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Ardelyx Investigative Site 228

St Louis, Missouri, 63042, United States

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Ardelyx Investigative Site 156

Billings, Montana, 59102, 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 222

Albuquerque, New Mexico, 87102, United States

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Ardelyx Investigative Site 264

Albuquerque, New Mexico, 87106, United States

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Ardelyx Investigative Site 230

Brooklyn, New York, 11206, United States

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Ardelyx Investigative Site 170

Great Neck, New York, 11023, United States

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Ardelyx Investigative Site 203

New Hyde Park, New York, 11040, United States

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Ardelyx Investigative Site 205

Fayetteville, North Carolina, 28304, United States

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Ardelyx Investigative Site 190

Greensboro, North Carolina, 27408, United States

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Ardelyx Investigative Site 194

Hickory, North Carolina, 28601, United States

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Ardelyx Investigative Site 285

Wilmington, North Carolina, 28401, United States

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Ardelyx Investigative Site 172

Beavercreek, Ohio, 45432, United States

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Ardelyx Investigative Site 204

Cincinnati, Ohio, 45212, United States

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Ardelyx Investigative Site 201

Cincinnati, Ohio, 45234, United States

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Ardelyx Investigative Site 173

Dayton, Ohio, 45429, United States

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Ardelyx Investigative Site 208

Franklin, Ohio, 45005, United States

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Ardelyx Investigative Site 171

Huber Heights, Ohio, 45424, United States

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Ardelyx Investigative Site 219

Lima, Ohio, 45806, United States

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Ardelyx Investigative Site 232

Wadsworth, Ohio, 44281, United States

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Ardelyx Investigative Site 236

Oklahoma City, Oklahoma, 73103, United States

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Ardelyx Investigative Site 273

Tulsa, Oklahoma, 74135, United States

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Ardelyx Investigative Site 220

Levittown, Pennsylvania, 19056, United States

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Ardelyx Investigative Site 248

East Providence, Rhode Island, 02914, United States

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Ardelyx Investigative Site 252

Columbia, South Carolina, 29204, United States

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Ardelyx Investigative Site 265

Gaffney, South Carolina, 29341, United States

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Ardelyx Investigative Site 246

Rapid City, South Dakota, 57702, United States

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Ardelyx Investigative Site 261

Sioux Falls, South Dakota, 57108, United States

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Ardelyx Investigative Site 217

Chattanooga, Tennessee, 37404, 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 266

Memphis, Tennessee, 38119, United States

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Ardelyx Investigative Site 235

Nashville, Tennessee, 37211, United States

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Ardelyx Investigative Site 279

Spring Hill, Tennessee, 37174, United States

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Ardelyx Investigative Site 180

Channelview, Texas, 77530, United States

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Ardelyx Investigative Site 286

Houston, Texas, 77036, United States

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Ardelyx Investigative Site 262

Houston, Texas, 77043, United States

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Ardelyx Investigative Site 185

Houston, Texas, 77079, United States

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Ardelyx Investigative Site 113

McKinney, Texas, 75071, United States

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Ardelyx Investigative Site 263

Port Arthur, Texas, 77640, United States

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Ardelyx Investigative Site 181

San Antonio, Texas, 78229, United States

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Ardelyx Investigative Site 186

San Antonio, Texas, 78258, United States

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Ardelyx Investigative Site 167

Salt Lake City, Utah, 84102, United States

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Ardelyx Investigative Site 249

Norfolk, Virginia, 23502, United States

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Ardelyx Investigative Site 231

Norfolk, Virginia, 23507, United States

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Ardelyx Investigative Site 258

Petersburg, Virginia, 23805, United States

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Ardelyx Investigative Site 245

Virginia Beach, Virginia, 23462, United States

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Ardelyx Investigative Site 242

Spokane, Washington, 99202, United States

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Ardelyx Investigative Site 195

Morgantown, West Virginia, 26505, United States

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Related Publications (3)

• 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

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: January 11, 2016
• First Posted: February 19, 2016
• Study Start: December 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 22, 2020
• Results First Posted: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (117)