CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Olorinabdrug
Likely dose
Olorinab active treatment for 8 weeksAI-extracted
Key inclusion· 3
  • ✓Confirmed Crohn's disease diagnosis ≥3 months with prior endoscopic and histopathologic documentation
  • ✓Quiescent to mildly active disease: SES-CD score <10 or fecal calprotectin <500 mcg/g within 4 weeks before screening
  • ✓Moderate to severe abdominal pain: AAPS ≥4 on 11-point scale for 7 consecutive days during screening
Key exclusion· 7
  • ✕Lactating, pregnant, or positive pregnancy test at screening or Day 1
  • ✕Recent (within 6 months) cerebrovascular disease, acute coronary syndrome, cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina
  • ✕Other significant chronic pain conditions that may influence abdominal pain assessment
  • ✕Extensive colonic resection, subtotal or total colectomy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03155945
NCT03155945Phase 2Completed
CompareCT.gov

A Randomized, Open-label, Parallel, Phase 2a Study to Determine the Tolerability, Pharmacokinetics, and Efficacy of APD371 in Participants With Crohn's Disease Experiencing Abdominal Pain

Arena Pharmaceuticals·interventional·Posted May 16, 2017·Updated Nov 2, 2021

In Brief

A Phase 2 clinical trial evaluating Olorinab for Crohn's Disease and Abdominal Pain. Completed, enrolled 14 participants across 7 sites.

Detailed Summary

The purpose of this randomized, open-label, parallel, phase 2a study is to determine the tolerability, pharmacokinetics, and efficacy of olorinab in participants with Crohn's disease experiencing abdominal pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease, Abdominal Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 16, 2017
Enrollment StartJul 19, 2017
Primary CompletionSep 10, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.1 years ago

Interventions

Olorinabdrug

Olorinab active treatment for 8 weeks.