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

Constipation Predominant Irritable Bowel Syndrome Clinical Trial

— T3MPO-1  

Official title:

A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study With a 4-Week Randomized Withdrawal Period 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: NCT02621892
• Other study ID #: TEN-01-301
• Status: Completed
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: April 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, 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.

Description:

During the 12-week treatment period, subjects will record daily assessments including:

frequency and timing of bowel movements; sensation and complete bowel emptying; consistency of bowel movements; degree of straining, worst abdominal pain, abdominal discomfort, abdominal bloating, abdominal fullness and abdominal cramping. Subjects will also record weekly assessments including: adequate relief of IBS severity, and constipation severity.

At the end of the 12-week treatment period, there will be a 4-week randomized withdrawal period in which subjects who complete the study in Tenapanor group will be randomized to either Tenapanor 50mg BID or placebo BID (1:1) and subjects who complete the study in the placebo group will be assigned to receive Tenapanor 50mg BID.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 606
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 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

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, 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)

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 293	Albuquerque	New Mexico
United States	Ardelyx Investigative Site 226	Asheville	North Carolina
United States	Ardelyx Investigative Site 234	Athens	Georgia
United States	Ardelyx Investigative Site 138	Atlanta	Georgia
United States	Ardelyx Investigative Site 148	Atlanta	Georgia
United States	Ardelyx Investigative Site 172	Beavercreek	Ohio
United States	Ardelyx Investigative Site 125	Belton	Missouri
United States	Ardelyx Investigative Site 156	Billings	Montana
United States	Ardelyx Investigative Site 114	Birmingham	Alabama
United States	Ardelyx Investigative Site 149	Birmingham	Alabama
United States	Ardelyx Investigative Site 102	Blue Island	Illinois
United States	Ardelyx Investigative Site 157	Boise	Idaho
United States	Ardelyx Investigative Site 135	Boston	Massachusetts
United States	Ardelyx Investigative Site 267	Brockton	Massachusetts
United States	Ardelyx Investigative Site 151	Brooklyn	New York
United States	Ardelyx Investigative Site 105	Canoga Park	California
United States	Ardelyx Investigative Site 119	Caro	Michigan
United States	Ardelyx Investigative Site 145	Chandler	Arizona
United States	Ardelyx Investigative Site 166	Charlotte	North Carolina
United States	Ardelyx Investigative Site 134	Chattanooga	Tennessee
United States	Ardelyx Investigative Site 128	Chesterfield	Michigan
United States	Ardelyx Investigative Site 143	Chula Vista	California
United States	Ardelyx Investigative Site 201	Cincinnati	Ohio
United States	Ardelyx Investigative Site 223	Cincinnati	Ohio
United States	Ardelyx Investigative Site 139	Columbus	Ohio
United States	Ardelyx Investigative Site 164	Corpus Christi	Texas
United States	Ardelyx Investigative Site 197	Corsicana	Texas
United States	Ardelyx Investigative Site 192	Crowley	Louisiana
United States	Ardelyx Investigative Site 178	Cutler Bay	Florida
United States	Ardelyx Investigative Site 173	Dayton	Ohio
United States	Ardelyx Investigative Site 146	Encino	California
United States	Ardelyx Investigative Site 147	Encino	California
United States	Ardelyx Investigative Site 162	Evanston	Illinois
United States	Ardelyx Investigative Site 205	Fayetteville	North Carolina
United States	Ardelyx Investigative Site 131	Fort Lauderdale	Florida
United States	Ardelyx Investigative Site 121	Franklin	Tennessee
United States	Ardelyx Investigative Site 170	Great Neck	New York
United States	Ardelyx Investigative Site 104	Greensboro	North Carolina
United States	Ardelyx Investigative Site 278	Hagerstown	Maryland
United States	Ardelyx Investigative Site 140	Harrisburg	Arkansas
United States	Ardelyx Investigative Site 225	Hartsdale	New York
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 287	Homestead	Florida
United States	Ardelyx Investigative Site 120	Houston	Texas
United States	Ardelyx Investigative Site 185	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 133	Jackson	Tennessee
United States	Ardelyx Investigative Site 144	Jenkintown	Pennsylvania
United States	Ardelyx Investigative Site 174	Kinston	North Carolina
United States	Ardelyx Investigative Site 109	Knoxville	Tennessee
United States	Ardelyx Investigative Site 182	Las Vegas	Nevada
United States	Ardelyx Investigative Site 275	Las Vegas	Nevada
United States	Ardelyx Investigative Site 276	Las Vegas	Nevada
United States	Ardelyx Investigative Site 122	Little Rock	Arkansas
United States	Ardelyx Investigative Site 161	Little Rock	Arkansas
United States	Ardelyx Investigative Site 274	Little Rock	Arkansas
United States	Ardelyx Investigative Site 107	Lomita	California
United States	Ardelyx Investigative Site 113	McKinney	Texas
United States	Ardelyx Investigative Site 117	Mentor	Ohio
United States	Ardelyx Investigative Site 188	Metairie	Louisiana
United States	Ardelyx Investigative Site 106	Miami	Florida
United States	Ardelyx Investigative Site 127	Miami Lakes	Florida
United States	Ardelyx Investigative Site 123	Miami Springs	Florida
United States	Ardelyx Investigative Site 177	Monroe	Louisiana
United States	Ardelyx Investigative Site 289	Mount Pleasant	South Carolina
United States	Ardelyx Investigative Site 184	Myrtle Beach	South Carolina
United States	Ardelyx Investigative Site 235	Nashville	Tennessee
United States	Ardelyx Investigative Site 206	New Windsor	New York
United States	Ardelyx Investigative Site 183	New York	New York
United States	Ardelyx Investigative Site 137	Norcross	Georgia
United States	Ardelyx Investigative Site 231	Norfolk	Virginia
United States	Ardelyx Investigative Site 281	North Charleston	South Carolina
United States	Ardelyx Investigative Site 112	North Hollywood	California
United States	Ardelyx Investigative Site 129	North Little Rock	Arkansas
United States	Ardelyx Investigative Site 110	Northridge	California
United States	Ardelyx Investigative Site 202	Oak Lawn	Illinois
United States	Ardelyx Investigative Site 142	Omaha	Nebraska
United States	Ardelyx Investigative Site 159	Orem	Utah
United States	Ardelyx Investigative Site 210	Phoenix	Arizona
United States	Ardelyx Investigative Site 296	Phoenix	Arizona
United States	Ardelyx Investigative Site 111	Plano	Texas
United States	Ardelyx Investigative Site 118	Plano	Texas
United States	Ardelyx Investigative Site 126	Pompano Beach	Florida
United States	Ardelyx Investigative Site 132	Port Orange	Florida
United States	Ardelyx Investigative Site 141	Richmond	Virginia
United States	Ardelyx Investigative Site 224	Saginaw	Michigan
United States	Ardelyx Investigative Site 150	Saint Petersburg	Florida
United States	Ardelyx Investigative Site 101	San Antonio	Texas
United States	Ardelyx Investigative Site 240	San Antonio	Texas
United States	Ardelyx Investigative Site 294	San Diego	California
United States	Ardelyx Investigative Site 207	Sandy	Utah
United States	Ardelyx Investigative Site 213	Savannah	Georgia
United States	Ardelyx Investigative Site 261	Sioux Falls	South Dakota
United States	Ardelyx Investigative Site 124	Snellville	Georgia
United States	Ardelyx Investigative Site 155	South Ogden	Utah
United States	Ardelyx Investigative Site 247	Springfield	Ohio
United States	Ardelyx Investigative Site 277	Tempe	Arizona
United States	Ardelyx Investigative Site 108	Thousand Oaks	California
United States	Ardelyx Investigative Site 259	Topeka	Kansas
United States	Ardelyx Investigative Site 255	Towson	Maryland
United States	Ardelyx Investigative Site 187	Tucson	Arizona
United States	Ardelyx Investigative Site 199	Tucson	Arizona
United States	Ardelyx Investigative Site 269	Tucson	Arizona
United States	Ardelyx Investigative Site 175	Vineland	New Jersey
United States	Ardelyx Investigative Site 254	West Palm Beach	Florida
United States	Ardelyx Investigative Site 280	Winston-Salem	North Carolina
United States	Ardelyx Investigative Site 198	Zachary	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Ardelyx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 of 12 Week Overall Complete Spontaneous Bowel Movement (CSBM)Responder Rate	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?"	12 weeks
Secondary	6 of 12 Week Overall Abdominal Pain Responder Rate	An overall abdominal pain responder is defined as a weekly responder for the first 6/12. 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	9 of 12 Week Overall Responder Rate	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.	12 weeks
Secondary	9 of 12 Week Overall CSBM Responder Rate	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?"	12 weeks
Secondary	9 of 12 Week Overall Abdominal Pain Responder Rate	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.	12 weeks