Clinical trial NCT02686138: A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation Predominant Irritable Bowel Syndrome
Lead sponsor: Ardelyx
Sponsor class: INDUSTRY
First posted: 2016-02-19
Enrollment: 593
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Percentage of Subjects With Overall Response for 6 Out of 12 Weeks
timeFrame: First 12 weeks
Secondary outcomes:
measure: Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 12 Weeks
timeFrame: First 12 weeks
measure: Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 12 Weeks
timeFrame: First 12 weeks
measure: Percentage of Subjects With Overall Response for 13 Out of 26 Weeks
timeFrame: 26 weeks
measure: Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks
timeFrame: 26 weeks
measure: Percentage of Subjects With Overall Abdominal Pain Response for 13 Out of 26 Weeks
timeFrame: 26 weeks
measure: Percentage of Subjects With Overall Response for 9 Out of 12 Weeks
timeFrame: First 12 weeks
measure: Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 9 Out of 12 Weeks
timeFrame: First 12 weeks
measure: Percentage of Subjects With Overall Abdominal Pain Response for 9 Out of 12 Weeks
timeFrame: First 12 weeks
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Ardelyx Investigative Site 257
state: Alabama
city: Foley
country: United States
facility: Ardelyx Investigative Site 200
state: Alabama
city: Huntsville
country: United States
facility: Ardelyx Investigative Site 103
state: Alabama
city: Huntsville
country: United States
facility: Ardelyx Investigative Site 244
state: Alabama
city: Huntsville
country: United States
facility: Ardelyx Investigative Site 251
state: Alabama
city: Huntsville
country: United States
facility: Ardelyx Investigative Site 100
state: Alabama
city: Saraland
country: United States
facility: Ardelyx Investigative Site 209
state: Alabama
city: Phoenix
country: United States
facility: Ardelyx Investigative Site 210
state: Arizona
city: Phoenix
country: United States
facility: Ardelyx Investigative Site 296
state: Arizona
city: Tucson
country: United States
facility: Ardelyx Investigative Site 269
state: Arizona
city: Tucson
country: United States
facility: Ardelyx Investigative Site 256
state: Arizona
city: Conway
country: United States
facility: Ardelyx Investigative Site 292
state: Arkansas
city: Little Rock
country: United States
facility: Ardelyx Investigative Site 122
state: Arkansas
city: Anaheim
country: United States
facility: Ardelyx Investigative Site 163
state: California
city: Canoga Park
country: United States
facility: Ardelyx Investigative Site 105
state: California
city: Chula Vista
country: United States
facility: Ardelyx Investigative Site 143
state: California
city: Encino
country: United States
facility: Ardelyx Investigative Site 147
state: California
city: La Mesa
country: United States
facility: Ardelyx Investigative Site 297
state: California
city: La Mirada
country: United States
facility: Ardelyx Investigative Site 284
state: California
city: Lomita
country: United States
facility: Ardelyx Investigative Site 107
state: California
city: Long Beach
country: United States
facility: Ardelyx Investigative Site 165
state: California
city: Orange
country: United States
facility: Ardelyx Investigative Site 211
state: California
city: Wheat Ridge
country: United States
facility: Ardelyx Investigative Site 233
state: Colorado
city: Bristol
country: United States
facility: Ardelyx Investigative Site 212
state: Connecticut
city: Brandon
country: United States
facility: Ardelyx Investigative Site 176
state: Florida
city: Cutler Bay
country: United States
facility: Ardelyx Investigative Site 178
state: Florida
city: Hialeah
country: United States
facility: Ardelyx Investigative Site 136
state: Florida
city: Hialeah
country: United States
facility: Ardelyx Investigative Site 130
state: Florida
city: Lynn Haven
country: United States
facility: Ardelyx Investigative Site 191
state: Florida
city: Miami Lakes
country: United States
facility: Ardelyx Investigative Site 127
state: Florida
city: Miami
country: United States
facility: Ardelyx Investigative Site 288
state: Florida
city: Miami
country: United States
facility: Ardelyx Investigative Site 106
state: Florida
city: Orlando
country: United States
facility: Ardelyx Investigative Site 179
state: Florida
city: Tampa
country: United States
facility: Ardelyx Investigative Site 290
state: Florida
city: West Palm Beach
country: United States
facility: Ardelyx Investigative Site 254
state: Florida
city: Atlanta
country: United States
facility: Ardelyx Investigative Site 138
state: Georgia
city: Atlanta
country: United States
facility: Ardelyx Investigative Site 148
state: Georgia
city: Atlanta
country: United States
facility: Ardelyx Investigative Site 253
state: Georgia
city: Decatur
country: United States
facility: Ardelyx Investigative Site 272
state: Georgia
city: Decatur
country: United States
facility: Ardelyx Investigative Site 229
state: Georgia
city: Marietta
country: United States
facility: Ardelyx Investigative Site 250
state: Georgia
city: Norcross
country: United States
facility: Ardelyx Investigative Site 137
state: Georgia
city: Savannah
country: United States
facility: Ardelyx Investigative Site 213
state: Georgia
city: Snellville
country: United States
facility: Ardelyx Investigative Site 124
state: Georgia
city: Burr Ridge
country: United States
facility: Ardelyx Investigative Site 268
state: Illinois
city: Evergreen Park
country: United States
facility: Ardelyx Investigative Site 227
state: Illinois
city: Hoffman Estates
country: United States
facility: Ardelyx Investigative Site 291
state: Illinois
city: Oak Lawn
country: United States
facility: Ardelyx Investigative Site 202
state: Illinois
city: Evansville
country: United States
facility: Ardelyx Investigative Site 218
state: Indiana
city: Madisonville
country: United States
facility: Ardelyx Investigative Site 158
state: Kentucky
city: Mandeville
country: United States
facility: Ardelyx Investigative Site 270
state: Louisiana
city: Marrero
country: United States
facility: Ardelyx Investigative Site 214
state: Louisiana
city: Metairie
country: United States
facility: Ardelyx Investigative Site 154
state: Louisiana
city: Shreveport
country: United States
facility: Ardelyx Investigative Site 195
state: Louisiana
city: Bangor
country: United States
facility: Ardelyx Investigative Site 271
state: Maine
city: Annapolis
country: United States
facility: Ardelyx Investigative Site 160
state: Maryland
city: Towson
country: United States
facility: Ardelyx Investigative Site 255
state: Maryland
city: Brockton
country: United States
facility: Ardelyx Investigative Site 267
state: Massachusetts
city: Ann Arbor
country: United States
facility: Ardelyx Investigative Site 260
state: Michigan
city: Buckley
country: United States
facility: Ardelyx Investigative Site 283
state: Michigan
city: Flint
country: United States
facility: Ardelyx Investigative Site 239
state: Michigan
city: Troy
country: United States
facility: Ardelyx Investigative Site 168
state: Michigan
city: Wyoming
country: United States
facility: Ardelyx Investigative Site 216
state: Michigan
city: Biloxi
country: United States
facility: Ardelyx Investigative Site 221
state: Mississippi
city: Jefferson City
country: United States
facility: Ardelyx Investigative Site 282
state: Missouri
city: Saint Louis
country: United States
facility: Ardelyx Investigative Site 228
state: Missouri
city: Billings
country: United States
facility: Ardelyx Investigative Site 156
state: Montana
city: Las Vegas
country: United States
facility: Ardelyx Investigative Site 182
state: Nevada
city: Vineland
country: United States
facility: Ardelyx Investigative Site 175
state: New Jersey
city: Albuquerque
country: United States
facility: Ardelyx Investigative Site 222
state: New Mexico
city: Albuquerque
country: United States
facility: Ardelyx Investigative Site 264
state: New Mexico
city: Brooklyn
country: United States
facility: Ardelyx Investigative Site 230
state: New York
city: Great Neck
country: United States
facility: Ardelyx Investigative Site 170
state: New York
city: New Hyde Park
country: United States
facility: Ardelyx Investigative Site 203
state: New York
city: Fayetteville
country: United States
facility: Ardelyx Investigative Site 205
state: North Carolina
city: Greensboro
country: United States
facility: Ardelyx Investigative Site 190
state: North Carolina
city: Hickory
country: United States
facility: Ardelyx Investigative Site 194
state: North Carolina
city: Wilmington
country: United States
facility: Ardelyx Investigative Site 285
state: North Carolina
city: Beavercreek
country: United States
facility: Ardelyx Investigative Site 172
state: Ohio
city: Cincinnati
country: United States
facility: Ardelyx Investigative Site 204
state: Ohio
city: Cincinnati
country: United States
facility: Ardelyx Investigative Site 201
state: Ohio
city: Dayton
country: United States
facility: Ardelyx Investigative Site 173
state: Ohio
city: Franklin
country: United States
facility: Ardelyx Investigative Site 208
state: Ohio
city: Huber Heights
country: United States
facility: Ardelyx Investigative Site 171
state: Ohio
city: Lima
country: United States
facility: Ardelyx Investigative Site 219
state: Ohio
city: Wadsworth
country: United States
facility: Ardelyx Investigative Site 232
state: Ohio
city: Oklahoma City
country: United States
facility: Ardelyx Investigative Site 236
state: Oklahoma
city: Tulsa
country: United States
facility: Ardelyx Investigative Site 273
state: Oklahoma
city: Levittown
country: United States
facility: Ardelyx Investigative Site 220
state: Pennsylvania
city: East Providence
country: United States
facility: Ardelyx Investigative Site 248
state: Rhode Island
city: Columbia
country: United States
facility: Ardelyx Investigative Site 252
state: South Carolina
city: Gaffney
country: United States
facility: Ardelyx Investigative Site 265
state: South Carolina
city: Rapid City
country: United States
facility: Ardelyx Investigative Site 246
state: South Dakota
city: Sioux Falls
country: United States
facility: Ardelyx Investigative Site 261
state: South Dakota
city: Chattanooga
country: United States
facility: Ardelyx Investigative Site 217
state: Tennessee
city: Franklin
country: United States
facility: Ardelyx Investigative Site 121
state: Tennessee
city: Hermitage
country: United States
facility: Ardelyx Investigative Site 189
state: Tennessee
city: Jackson
country: United States
facility: Ardelyx Investigative Site 133
state: Tennessee
city: Knoxville
country: United States
facility: Ardelyx Investigative Site 109
state: Tennessee
city: Memphis
country: United States
facility: Ardelyx Investigative Site 266
state: Tennessee
city: Nashville
country: United States
facility: Ardelyx Investigative Site 235
state: Tennessee
city: Spring Hill
country: United States
facility: Ardelyx Investigative Site 279
state: Tennessee
city: Channelview
country: United States
facility: Ardelyx Investigative Site 180
state: Texas
city: Houston
country: United States
facility: Ardelyx Investigative Site 286
state: Texas
city: Houston
country: United States
facility: Ardelyx Investigative Site 262
state: Texas
city: Houston
country: United States
facility: Ardelyx Investigative Site 185
state: Texas
city: McKinney
country: United States
facility: Ardelyx Investigative Site 113
state: Texas
city: Port Arthur
country: United States
facility: Ardelyx Investigative Site 263
state: Texas
city: San Antonio
country: United States
facility: Ardelyx Investigative Site 181
state: Texas
city: San Antonio
country: United States
facility: Ardelyx Investigative Site 186
state: Texas
city: Salt Lake City
country: United States
facility: Ardelyx Investigative Site 167
state: Utah
city: Norfolk
country: United States
facility: Ardelyx Investigative Site 249
state: Virginia
city: Norfolk
country: United States
facility: Ardelyx Investigative Site 231
state: Virginia
city: Petersburg
country: United States
facility: Ardelyx Investigative Site 258
state: Virginia
city: Virginia Beach
country: United States
facility: Ardelyx Investigative Site 245
state: Virginia
city: Spokane
country: United States
facility: Ardelyx Investigative Site 242
state: Washington
city: Morgantown
country: United States
facility: Ardelyx Investigative Site 195
state: West Virginia
Study officials:
affiliation: Ardelyx, Inc.
name: David P Rosenbaum, Ph.D.
role: STUDY_CHAIR
References:
citation: 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.