ClinicalTrials.gov record
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
ClinicalTrials.gov ID: NCT02621892
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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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02621892
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 606 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2015 (Type not available)
- Primary completion
- Mar 2017 (Actual)
- Completion
- Apr 2017 (Actual)
- Last update posted
- Apr 21, 2020
2015 – 2017
United States locations
- U.S. sites
- 111
- U.S. states
- 29
- U.S. cities
- 95
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ardelyx Investigative Site 149 | Birmingham | Alabama | 35216 | — |
| Ardelyx Investigative Site 114 | Birmingham | Alabama | 35242 | — |
| Ardelyx Investigative Site 103 | Huntsville | Alabama | 35801 | — |
| Ardelyx Investigative Site 100 | Huntsville | Alabama | 35802 | — |
| Ardelyx Investigative Site 145 | Chandler | Arizona | 85224 | — |
| Ardelyx Investigative Site 210 | Phoenix | Arizona | 85018 | — |
| Ardelyx Investigative Site 296 | Phoenix | Arizona | 85018 | — |
| Ardelyx Investigative Site 277 | Tempe | Arizona | 85283 | — |
| Ardelyx Investigative Site 269 | Tucson | Arizona | 85704 | — |
| Ardelyx Investigative Site 187 | Tucson | Arizona | 85712 | — |
| Ardelyx Investigative Site 199 | Tucson | Arizona | 85741 | — |
| Ardelyx Investigative Site 140 | Harrisburg | Arkansas | 72432 | — |
| Ardelyx Investigative Site 274 | Little Rock | Arkansas | 72209 | — |
| Ardelyx Investigative Site 161 | Little Rock | Arkansas | 72211 | — |
| Ardelyx Investigative Site 122 | Little Rock | Arkansas | 72212 | — |
| Ardelyx Investigative Site 129 | North Little Rock | Arkansas | 72117 | — |
| Ardelyx Investigative Site 105 | Canoga Park | California | 91303 | — |
| Ardelyx Investigative Site 143 | Chula Vista | California | 91910 | — |
| Ardelyx Investigative Site 146 | Encino | California | 91436 | — |
| Ardelyx Investigative Site 147 | Encino | California | 91436 | — |
| Ardelyx Investigative Site 107 | Lomita | California | 90717 | — |
| Ardelyx Investigative Site 112 | North Hollywood | California | 91606 | — |
| Ardelyx Investigative Site 110 | Northridge | California | 91325 | — |
| Ardelyx Investigative Site 294 | San Diego | California | 92123 | — |
| Ardelyx Investigative Site 108 | Thousand Oaks | California | 91360 | — |
| Ardelyx Investigative Site 178 | Cutler Bay | Florida | 33157 | — |
| Ardelyx Investigative Site 131 | Fort Lauderdale | Florida | 33308 | — |
| Ardelyx Investigative Site 136 | Hialeah | Florida | 33012 | — |
| Ardelyx Investigative Site 130 | Hialeah | Florida | 33016 | — |
| Ardelyx Investigative Site 287 | Homestead | Florida | 33030 | — |
| Ardelyx Investigative Site 106 | Miami | Florida | 33186 | — |
| Ardelyx Investigative Site 127 | Miami Lakes | Florida | 33014 | — |
| Ardelyx Investigative Site 123 | Miami Springs | Florida | 33166 | — |
| Ardelyx Investigative Site 126 | Pompano Beach | Florida | 33060 | — |
| Ardelyx Investigative Site 132 | Port Orange | Florida | 32129 | — |
| Ardelyx Investigative Site 150 | St. Petersburg | Florida | 33709 | — |
| Ardelyx Investigative Site 254 | West Palm Beach | Florida | 33409 | — |
| Ardelyx Investigative Site 234 | Athens | Georgia | 30607 | — |
| Ardelyx Investigative Site 138 | Atlanta | Georgia | 30312 | — |
| Ardelyx Investigative Site 148 | Atlanta | Georgia | 30342 | — |
| Ardelyx Investigative Site 137 | Norcross | Georgia | 30071 | — |
| Ardelyx Investigative Site 213 | Savannah | Georgia | 31406 | — |
| Ardelyx Investigative Site 124 | Snellville | Georgia | 30078 | — |
| Ardelyx Investigative Site 157 | Boise | Idaho | 83642 | — |
| Ardelyx Investigative Site 102 | Blue Island | Illinois | 60406 | — |
| Ardelyx Investigative Site 162 | Evanston | Illinois | 60201 | — |
| Ardelyx Investigative Site 202 | Oak Lawn | Illinois | 60453 | — |
| Ardelyx Investigative Site 259 | Topeka | Kansas | 66606 | — |
| Ardelyx Investigative Site 192 | Crowley | Louisiana | 70526 | — |
| Ardelyx Investigative Site 188 | Metairie | Louisiana | 70006 | — |
| Ardelyx Investigative Site 177 | Monroe | Louisiana | 71201 | — |
| Ardelyx Investigative Site 198 | Zachary | Louisiana | 70791 | — |
| Ardelyx Investigative Site 278 | Hagerstown | Maryland | 21742 | — |
| Ardelyx Investigative Site 255 | Towson | Maryland | 21204 | — |
| Ardelyx Investigative Site 135 | Boston | Massachusetts | 02131 | — |
| Ardelyx Investigative Site 267 | Brockton | Massachusetts | 02302 | — |
| Ardelyx Investigative Site 119 | Caro | Michigan | 48723 | — |
| Ardelyx Investigative Site 128 | Chesterfield | Michigan | 48047 | — |
| Ardelyx Investigative Site 224 | Saginaw | Michigan | 48604 | — |
| Ardelyx Investigative Site 125 | Belton | Missouri | 64012 | — |
| Ardelyx Investigative Site 156 | Billings | Montana | 59102 | — |
| Ardelyx Investigative Site 142 | Omaha | Nebraska | 68114 | — |
| Ardelyx Investigative Site 275 | Las Vegas | Nevada | 89103 | — |
| Ardelyx Investigative Site 276 | Las Vegas | Nevada | 89119 | — |
| Ardelyx Investigative Site 182 | Las Vegas | Nevada | 89128 | — |
| Ardelyx Investigative Site 175 | Vineland | New Jersey | 08360 | — |
| Ardelyx Investigative Site 293 | Albuquerque | New Mexico | 87108 | — |
| Ardelyx Investigative Site 151 | Brooklyn | New York | 11215 | — |
| Ardelyx Investigative Site 170 | Great Neck | New York | 11023 | — |
| Ardelyx Investigative Site 225 | Hartsdale | New York | 10530 | — |
| Ardelyx Investigative Site 206 | New Windsor | New York | 12553 | — |
| Ardelyx Investigative Site 183 | New York | New York | 10036 | — |
| Ardelyx Investigative Site 226 | Asheville | North Carolina | 28801 | — |
| Ardelyx Investigative Site 166 | Charlotte | North Carolina | 28210 | — |
| Ardelyx Investigative Site 205 | Fayetteville | North Carolina | 28304 | — |
| Ardelyx Investigative Site 104 | Greensboro | North Carolina | 27403 | — |
| Ardelyx Investigative Site 174 | Kinston | North Carolina | 28501 | — |
| Ardelyx Investigative Site 280 | Winston-Salem | North Carolina | 27103 | — |
| Ardelyx Investigative Site 172 | Beavercreek | Ohio | 45432 | — |
| Ardelyx Investigative Site 223 | Cincinnati | Ohio | 45219 | — |
| Ardelyx Investigative Site 201 | Cincinnati | Ohio | 45234 | — |
| Ardelyx Investigative Site 139 | Columbus | Ohio | 43214 | — |
| Ardelyx Investigative Site 173 | Dayton | Ohio | 45429 | — |
| Ardelyx Investigative Site 171 | Huber Heights | Ohio | 45424 | — |
| Ardelyx Investigative Site 117 | Mentor | Ohio | 44060 | — |
| Ardelyx Investigative Site 247 | Springfield | Ohio | 45504 | — |
| Ardelyx Investigative Site 144 | Jenkintown | Pennsylvania | 19046 | — |
| Ardelyx Investigative Site 289 | Mt. Pleasant | South Carolina | 29464 | — |
| Ardelyx Investigative Site 184 | Myrtle Beach | South Carolina | 29588 | — |
| Ardelyx Investigative Site 281 | North Charleston | South Carolina | 29406 | — |
| Ardelyx Investigative Site 261 | Sioux Falls | South Dakota | 57108 | — |
| Ardelyx Investigative Site 134 | Chattanooga | Tennessee | 37421 | — |
| Ardelyx Investigative Site 121 | Franklin | Tennessee | 37064 | — |
| Ardelyx Investigative Site 189 | Hermitage | Tennessee | 37076 | — |
| Ardelyx Investigative Site 133 | Jackson | Tennessee | 38305 | — |
| Ardelyx Investigative Site 109 | Knoxville | Tennessee | 37909 | — |
| Ardelyx Investigative Site 235 | Nashville | Tennessee | 37211 | — |
| Ardelyx Investigative Site 164 | Corpus Christi | Texas | 78413 | — |
| Ardelyx Investigative Site 197 | Corsicana | Texas | 75110 | — |
| Ardelyx Investigative Site 185 | Houston | Texas | 77079 | — |
| Ardelyx Investigative Site 120 | Houston | Texas | 77090 | — |
| Ardelyx Investigative Site 113 | McKinney | Texas | 75071 | — |
| Ardelyx Investigative Site 111 | Plano | Texas | 75093 | — |
| Ardelyx Investigative Site 118 | Plano | Texas | 75093 | — |
| Ardelyx Investigative Site 101 | San Antonio | Texas | 78215 | — |
| Ardelyx Investigative Site 240 | San Antonio | Texas | 78229 | — |
| Ardelyx Investigative Site 159 | Orem | Utah | 84058 | — |
| Ardelyx Investigative Site 207 | Sandy City | Utah | 84094 | — |
| Ardelyx Investigative Site 155 | South Ogden | Utah | 84405 | — |
| Ardelyx Investigative Site 231 | Norfolk | Virginia | 23507 | — |
| Ardelyx Investigative Site 141 | Richmond | Virginia | 23294 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02621892, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 21, 2020 · Synced Nov 13, 2026
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