ClinicalTrials.gov record
A 26-Week Study to Evaluate the Efficacy and Safety of Tenapanor in IBS-C
ClinicalTrials.gov ID: NCT02686138
Public ClinicalTrials.gov record NCT02686138. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02686138
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 593 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
- Nov 30, 2015
- Primary completion
- Jul 31, 2017
- Completion
- Sep 30, 2017
- Last update posted
- Apr 21, 2020
2015 – 2017
United States locations
- U.S. sites
- 117
- U.S. states
- 36
- U.S. cities
- 101
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ardelyx Investigative Site 257 | Dothan | Alabama | 36305 | — |
| Ardelyx Investigative Site 200 | Foley | Alabama | 36535 | — |
| Ardelyx Investigative Site 103 | Huntsville | Alabama | 35801 | — |
| Ardelyx Investigative Site 244 | Huntsville | Alabama | 35801 | — |
| Ardelyx Investigative Site 251 | Huntsville | Alabama | 35801 | — |
| Ardelyx Investigative Site 100 | Huntsville | Alabama | 35802 | — |
| Ardelyx Investigative Site 209 | Saraland | Alabama | 36571 | — |
| Ardelyx Investigative Site 210 | Phoenix | Arizona | 85018 | — |
| Ardelyx Investigative Site 296 | Phoenix | Arizona | 85018 | — |
| Ardelyx Investigative Site 269 | Tucson | Arizona | 85704 | — |
| Ardelyx Investigative Site 256 | Tucson | Arizona | 85710 | — |
| Ardelyx Investigative Site 292 | Conway | Arkansas | 72034 | — |
| Ardelyx Investigative Site 122 | Little Rock | Arkansas | 72212 | — |
| Ardelyx Investigative Site 163 | Anaheim | California | 92801 | — |
| Ardelyx Investigative Site 105 | Canoga Park | California | 91303 | — |
| Ardelyx Investigative Site 143 | Chula Vista | California | 91910 | — |
| Ardelyx Investigative Site 147 | Encino | California | 91436 | — |
| Ardelyx Investigative Site 297 | La Mesa | California | 91942 | — |
| Ardelyx Investigative Site 284 | La Mirada | California | 90638 | — |
| Ardelyx Investigative Site 107 | Lomita | California | 90717 | — |
| Ardelyx Investigative Site 165 | Long Beach | California | 90807 | — |
| Ardelyx Investigative Site 211 | Orange | California | 92868 | — |
| Ardelyx Investigative Site 233 | Wheat Ridge | Colorado | 80033 | — |
| Ardelyx Investigative Site 212 | Bristol | Connecticut | 06010 | — |
| Ardelyx Investigative Site 176 | Brandon | Florida | 33511 | — |
| Ardelyx Investigative Site 178 | Cutler Bay | Florida | 33157 | — |
| Ardelyx Investigative Site 136 | Hialeah | Florida | 33012 | — |
| Ardelyx Investigative Site 130 | Hialeah | Florida | 33016 | — |
| Ardelyx Investigative Site 191 | Lynn Haven | Florida | 32444 | — |
| Ardelyx Investigative Site 288 | Miami | Florida | 33144 | — |
| Ardelyx Investigative Site 106 | Miami | Florida | 33186 | — |
| Ardelyx Investigative Site 127 | Miami Lakes | Florida | 33014 | — |
| Ardelyx Investigative Site 179 | Orlando | Florida | 32803 | — |
| Ardelyx Investigative Site 290 | Tampa | Florida | 33607 | — |
| Ardelyx Investigative Site 254 | West Palm Beach | Florida | 33409 | — |
| Ardelyx Investigative Site 138 | Atlanta | Georgia | 30312 | — |
| Ardelyx Investigative Site 148 | Atlanta | Georgia | 30342 | — |
| Ardelyx Investigative Site 253 | Atlanta | Georgia | 30342 | — |
| Ardelyx Investigative Site 272 | Decatur | Georgia | 30032 | — |
| Ardelyx Investigative Site 229 | Decatur | Georgia | 30033 | — |
| Ardelyx Investigative Site 250 | Marietta | Georgia | 30060 | — |
| Ardelyx Investigative Site 137 | Norcross | Georgia | 30071 | — |
| Ardelyx Investigative Site 213 | Savannah | Georgia | 31406 | — |
| Ardelyx Investigative Site 124 | Snellville | Georgia | 30078 | — |
| Ardelyx Investigative Site 268 | Burr Ridge | Illinois | 60527 | — |
| Ardelyx Investigative Site 227 | Evergreen Park | Illinois | 60805 | — |
| Ardelyx Investigative Site 291 | Hoffman Estates | Illinois | 60169 | — |
| Ardelyx Investigative Site 202 | Oak Lawn | Illinois | 60453 | — |
| Ardelyx Investigative Site 218 | Evansville | Indiana | 47714 | — |
| Ardelyx Investigative Site 158 | Madisonville | Kentucky | 42431 | — |
| Ardelyx Investigative Site 270 | Mandeville | Louisiana | 70471 | — |
| Ardelyx Investigative Site 214 | Marrero | Louisiana | 70072 | — |
| Ardelyx Investigative Site 154 | Metairie | Louisiana | 70006 | — |
| Ardelyx Investigative Site 195 | Shreveport | Louisiana | 71103 | — |
| Ardelyx Investigative Site 271 | Bangor | Maine | 04401 | — |
| Ardelyx Investigative Site 160 | Annapolis | Maryland | 21401 | — |
| Ardelyx Investigative Site 255 | Towson | Maryland | 21204 | — |
| Ardelyx Investigative Site 267 | Brockton | Massachusetts | 02302 | — |
| Ardelyx Investigative Site 260 | Ann Arbor | Michigan | 48106 | — |
| Ardelyx Investigative Site 283 | Buckley | Michigan | 49620 | — |
| Ardelyx Investigative Site 239 | Flint | Michigan | 48504 | — |
| Ardelyx Investigative Site 168 | Troy | Michigan | 48098 | — |
| Ardelyx Investigative Site 216 | Wyoming | Michigan | 49519 | — |
| Ardelyx Investigative Site 221 | Biloxi | Mississippi | 39531 | — |
| Ardelyx Investigative Site 282 | Jefferson City | Missouri | 65109 | — |
| Ardelyx Investigative Site 228 | St Louis | Missouri | 63042 | — |
| Ardelyx Investigative Site 156 | Billings | Montana | 59102 | — |
| Ardelyx Investigative Site 182 | Las Vegas | Nevada | 89128 | — |
| Ardelyx Investigative Site 175 | Vineland | New Jersey | 08360 | — |
| Ardelyx Investigative Site 222 | Albuquerque | New Mexico | 87102 | — |
| Ardelyx Investigative Site 264 | Albuquerque | New Mexico | 87106 | — |
| Ardelyx Investigative Site 230 | Brooklyn | New York | 11206 | — |
| Ardelyx Investigative Site 170 | Great Neck | New York | 11023 | — |
| Ardelyx Investigative Site 203 | New Hyde Park | New York | 11040 | — |
| Ardelyx Investigative Site 205 | Fayetteville | North Carolina | 28304 | — |
| Ardelyx Investigative Site 190 | Greensboro | North Carolina | 27408 | — |
| Ardelyx Investigative Site 194 | Hickory | North Carolina | 28601 | — |
| Ardelyx Investigative Site 285 | Wilmington | North Carolina | 28401 | — |
| Ardelyx Investigative Site 172 | Beavercreek | Ohio | 45432 | — |
| Ardelyx Investigative Site 204 | Cincinnati | Ohio | 45212 | — |
| Ardelyx Investigative Site 201 | Cincinnati | Ohio | 45234 | — |
| Ardelyx Investigative Site 173 | Dayton | Ohio | 45429 | — |
| Ardelyx Investigative Site 208 | Franklin | Ohio | 45005 | — |
| Ardelyx Investigative Site 171 | Huber Heights | Ohio | 45424 | — |
| Ardelyx Investigative Site 219 | Lima | Ohio | 45806 | — |
| Ardelyx Investigative Site 232 | Wadsworth | Ohio | 44281 | — |
| Ardelyx Investigative Site 236 | Oklahoma City | Oklahoma | 73103 | — |
| Ardelyx Investigative Site 273 | Tulsa | Oklahoma | 74135 | — |
| Ardelyx Investigative Site 220 | Levittown | Pennsylvania | 19056 | — |
| Ardelyx Investigative Site 248 | East Providence | Rhode Island | 02914 | — |
| Ardelyx Investigative Site 252 | Columbia | South Carolina | 29204 | — |
| Ardelyx Investigative Site 265 | Gaffney | South Carolina | 29341 | — |
| Ardelyx Investigative Site 246 | Rapid City | South Dakota | 57702 | — |
| Ardelyx Investigative Site 261 | Sioux Falls | South Dakota | 57108 | — |
| Ardelyx Investigative Site 217 | Chattanooga | Tennessee | 37404 | — |
| 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 266 | Memphis | Tennessee | 38119 | — |
| Ardelyx Investigative Site 235 | Nashville | Tennessee | 37211 | — |
| Ardelyx Investigative Site 279 | Spring Hill | Tennessee | 37174 | — |
| Ardelyx Investigative Site 180 | Channelview | Texas | 77530 | — |
| Ardelyx Investigative Site 286 | Houston | Texas | 77036 | — |
| Ardelyx Investigative Site 262 | Houston | Texas | 77043 | — |
| Ardelyx Investigative Site 185 | Houston | Texas | 77079 | — |
| Ardelyx Investigative Site 113 | McKinney | Texas | 75071 | — |
| Ardelyx Investigative Site 263 | Port Arthur | Texas | 77640 | — |
| Ardelyx Investigative Site 181 | San Antonio | Texas | 78229 | — |
| Ardelyx Investigative Site 186 | San Antonio | Texas | 78258 | — |
| Ardelyx Investigative Site 167 | Salt Lake City | Utah | 84102 | — |
| Ardelyx Investigative Site 249 | Norfolk | Virginia | 23502 | — |
| Ardelyx Investigative Site 231 | Norfolk | Virginia | 23507 | — |
| Ardelyx Investigative Site 258 | Petersburg | Virginia | 23805 | — |
| Ardelyx Investigative Site 245 | Virginia Beach | Virginia | 23462 | — |
| Ardelyx Investigative Site 242 | Spokane | Washington | 99202 | — |
| Ardelyx Investigative Site 195 | Morgantown | West Virginia | 26505 | — |
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 NCT02686138, 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 Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02686138 live on ClinicalTrials.gov.