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

Constipation Predominant Irritable Bowel Syndrome Clinical Trial

— T3MPO-2  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02686138
• Other study ID #: TEN-01-302
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: October 2017

Study information

• Verified date: April 2020
• Source: Ardelyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 593
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Constipation
• Constipation Predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Tenapanor

• Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ardelyx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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?"	First 12 weeks
Secondary	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.	First 12 weeks
Secondary	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.	26 weeks
Secondary	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?"	26 weeks
Secondary	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.	26 weeks
Secondary	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.	First 12 weeks
Secondary	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?"	First 12 weeks
Secondary	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.	First 12 weeks