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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Ardelyx
Study ID
NCT02621892
Phase
PHASE3
Status
Completed

Conditions

  • Constipation Predominant Irritable Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 31, 2015
Status verified
Apr 2020
Primary completion
Mar 31, 2017
Completion
Apr 30, 2017

Study Design

Enrollment
606 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 50mg BID
    Tenapanor
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

6 of 12 Week Overall Responder Rate [ Time Frame: 12 weeks ]

Locations (111)

FacilityCityStateZIPSite coordinators
Ardelyx Investigative Site 114BirminghamAlabama35242-
Ardelyx Investigative Site 149BirminghamAlabama35216-
Ardelyx Investigative Site 100HuntsvilleAlabama35802-
Ardelyx Investigative Site 103HuntsvilleAlabama35801-
Ardelyx Investigative Site 145ChandlerArizona85224-
Ardelyx Investigative Site 210PhoenixArizona85018-
Ardelyx Investigative Site 296PhoenixArizona85018-
Ardelyx Investigative Site 277TempeArizona85283-
Ardelyx Investigative Site 187TucsonArizona85712-
Ardelyx Investigative Site 199TucsonArizona85741-
Ardelyx Investigative Site 269TucsonArizona85704-
Ardelyx Investigative Site 140HarrisburgArkansas72432-
Ardelyx Investigative Site 122Little RockArkansas72212-
Ardelyx Investigative Site 161Little RockArkansas72211-
Ardelyx Investigative Site 274Little RockArkansas72209-
Ardelyx Investigative Site 129North Little RockArkansas72117-
Ardelyx Investigative Site 105Canoga ParkCalifornia91303-
Ardelyx Investigative Site 143Chula VistaCalifornia91910-
Ardelyx Investigative Site 146EncinoCalifornia91436-
Ardelyx Investigative Site 147EncinoCalifornia91436-
Ardelyx Investigative Site 107LomitaCalifornia90717-
Ardelyx Investigative Site 112North HollywoodCalifornia91606-
Ardelyx Investigative Site 110NorthridgeCalifornia91325-
Ardelyx Investigative Site 294San DiegoCalifornia92123-
Ardelyx Investigative Site 108Thousand OaksCalifornia91360-
Ardelyx Investigative Site 178Cutler BayFlorida33157-
Ardelyx Investigative Site 131Fort LauderdaleFlorida33308-
Ardelyx Investigative Site 130HialeahFlorida33016-
Ardelyx Investigative Site 136HialeahFlorida33012-
Ardelyx Investigative Site 287HomesteadFlorida33030-
Ardelyx Investigative Site 106MiamiFlorida33186-
Ardelyx Investigative Site 127Miami LakesFlorida33014-
Ardelyx Investigative Site 123Miami SpringsFlorida33166-
Ardelyx Investigative Site 126Pompano BeachFlorida33060-
Ardelyx Investigative Site 132Port OrangeFlorida32129-
Ardelyx Investigative Site 150St. PetersburgFlorida33709-
Ardelyx Investigative Site 254West Palm BeachFlorida33409-
Ardelyx Investigative Site 234AthensGeorgia30607-
Ardelyx Investigative Site 138AtlantaGeorgia30312-
Ardelyx Investigative Site 148AtlantaGeorgia30342-
Ardelyx Investigative Site 137NorcrossGeorgia30071-
Ardelyx Investigative Site 213SavannahGeorgia31406-
Ardelyx Investigative Site 124SnellvilleGeorgia30078-
Ardelyx Investigative Site 157BoiseIdaho83642-
Ardelyx Investigative Site 102Blue IslandIllinois60406-
Ardelyx Investigative Site 162EvanstonIllinois60201-
Ardelyx Investigative Site 202Oak LawnIllinois60453-
Ardelyx Investigative Site 259TopekaKansas66606-
Ardelyx Investigative Site 192CrowleyLouisiana70526-
Ardelyx Investigative Site 188MetairieLouisiana70006-
Ardelyx Investigative Site 177MonroeLouisiana71201-
Ardelyx Investigative Site 198ZacharyLouisiana70791-
Ardelyx Investigative Site 278HagerstownMaryland21742-
Ardelyx Investigative Site 255TowsonMaryland21204-
Ardelyx Investigative Site 135BostonMassachusetts02131-
Ardelyx Investigative Site 267BrocktonMassachusetts02302-
Ardelyx Investigative Site 119CaroMichigan48723-
Ardelyx Investigative Site 128ChesterfieldMichigan48047-
Ardelyx Investigative Site 224SaginawMichigan48604-
Ardelyx Investigative Site 125BeltonMissouri64012-
Ardelyx Investigative Site 156BillingsMontana59102-
Ardelyx Investigative Site 142OmahaNebraska68114-
Ardelyx Investigative Site 182Las VegasNevada89128-
Ardelyx Investigative Site 275Las VegasNevada89103-
Ardelyx Investigative Site 276Las VegasNevada89119-
Ardelyx Investigative Site 175VinelandNew Jersey08360-
Ardelyx Investigative Site 293AlbuquerqueNew Mexico87108-
Ardelyx Investigative Site 151BrooklynNew York11215-
Ardelyx Investigative Site 170Great NeckNew York11023-
Ardelyx Investigative Site 225HartsdaleNew York10530-
Ardelyx Investigative Site 206New WindsorNew York12553-
Ardelyx Investigative Site 183New YorkNew York10036-
Ardelyx Investigative Site 226AshevilleNorth Carolina28801-
Ardelyx Investigative Site 166CharlotteNorth Carolina28210-
Ardelyx Investigative Site 205FayettevilleNorth Carolina28304-
Ardelyx Investigative Site 104GreensboroNorth Carolina27403-
Ardelyx Investigative Site 174KinstonNorth Carolina28501-
Ardelyx Investigative Site 280Winston-SalemNorth Carolina27103-
Ardelyx Investigative Site 172BeavercreekOhio45432-
Ardelyx Investigative Site 201CincinnatiOhio45234-
Ardelyx Investigative Site 223CincinnatiOhio45219-
Ardelyx Investigative Site 139ColumbusOhio43214-
Ardelyx Investigative Site 173DaytonOhio45429-
Ardelyx Investigative Site 171Huber HeightsOhio45424-
Ardelyx Investigative Site 117MentorOhio44060-
Ardelyx Investigative Site 247SpringfieldOhio45504-
Ardelyx Investigative Site 144JenkintownPennsylvania19046-
Ardelyx Investigative Site 289Mt. PleasantSouth Carolina29464-
Ardelyx Investigative Site 184Myrtle BeachSouth Carolina29588-
Ardelyx Investigative Site 281North CharlestonSouth Carolina29406-
Ardelyx Investigative Site 261Sioux FallsSouth Dakota57108-
Ardelyx Investigative Site 134ChattanoogaTennessee37421-
Ardelyx Investigative Site 121FranklinTennessee37064-
Ardelyx Investigative Site 189HermitageTennessee37076-
Ardelyx Investigative Site 133JacksonTennessee38305-
Ardelyx Investigative Site 109KnoxvilleTennessee37909-
Ardelyx Investigative Site 235NashvilleTennessee37211-
Ardelyx Investigative Site 164Corpus ChristiTexas78413-
Ardelyx Investigative Site 197CorsicanaTexas75110-
Ardelyx Investigative Site 120HoustonTexas77090-
Ardelyx Investigative Site 185HoustonTexas77079-
Ardelyx Investigative Site 113McKinneyTexas75071-
Ardelyx Investigative Site 111PlanoTexas75093-
Ardelyx Investigative Site 118PlanoTexas75093-
Ardelyx Investigative Site 101San AntonioTexas78215-
Ardelyx Investigative Site 240San AntonioTexas78229-
Ardelyx Investigative Site 159OremUtah84058-
Ardelyx Investigative Site 207Sandy CityUtah84094-
Ardelyx Investigative Site 155South OgdenUtah84405-
Ardelyx Investigative Site 231NorfolkVirginia23507-
Ardelyx Investigative Site 141RichmondVirginia23294-

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