Trial Profile
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients With Gastroesophageal Reflux Disease While Receiving Proton Pump Inhibitors
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 20 Aug 2021
Price :
$35
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At a glance
- Drugs Colesevelam (Primary)
- Indications Gastro-oesophageal reflux
- Focus Registrational; Therapeutic Use
- Sponsors Ironwood Pharmaceuticals
- 14 Dec 2020 Status changed from active, no longer recruiting to completed.
- 29 Sep 2020 According to an Ironwood Pharmaceuticals media release, the company unblinded the data following the assessment from an independent data monitoring committee and confirmed that IW-3718-302 did not meet the criteria, including the primary endpoint of achieving a statistically significant improvement in heartburn severity and based on these findings, the company plans to discontinue development of IW-3718 including stopping enrollment in IW-3718-301, the second Phase III trial.
- 29 Sep 2020 Primary endpoint (Change From Baseline at Week 8 in Weekly Heartburn Severity Score (WHSS)) has not been met, according to an Ironwood Pharmaceuticals media release.