Skip to main content
OpenTrials
Completed

NCT Number: NCT03155945

Tolerability, Pharmacokinetics, and Efficacy of APD371 in Participants With Crohn's Disease Experiencing Abdominal Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research of Brandon, Brandon, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • A clinical diagnosis of Crohn's disease for at least 3 months prior to screening corroborated by prior endoscopic and histopathologic documentation consistent with Crohn's disease.
  • Quiescent to mildly active inflammatory Crohn's disease defined with a total of simple endoscopy score for Crohn's disease (SES-CD) score of < 10 or fecal calprotectin < 500 mcg/g within 4 weeks before Screening.
  • Moderate to severe abdominal pain as defined by average abdominal pain score (AAPS) of >/= 4points on 7 consecutive days of the screening period up to Day -2. AAPS will be based on the 11-point numeric rating scale where 0 (no abdominal pain) to 10 (worst possible abdominal pain).

Key Exclusion Criteria:

  • Female participants who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 prior to study drug administration.
  • Recent history (within 6 months of screening visit) of cerebrovascular disease, Acute Coronary Syndrome, Cerebrovascular accident, Transient ischemic attack, Myocardial infarction, unstable angina.
  • Other significant chronic pain conditions that in the opinion of the Investigator may influence the abdominal pain score.
  • History of extensive colonic resection, subtotal or total colectomy.
  • History of >3 small bowel resections or diagnosis of short bowel syndrome or who have undergone bowel resection within 6 months prior to randomization.
  • Chronic active hepatitis B within the last year (unless shown at the time of study entry to be hepatitis B antigen negative) or any history of hepatitis C.
  • Evidence of current gastro-intestinal infection (bacterial or parasitic) or significant infection within 45 days of screening.

Note: other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Olorinab

Drug

Olorinab active treatment for 8 weeks.

Other names: APD371

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Up to approximately 12 weeks

    TEAE was defined as an adverse event (AE) that occurred after first dose of olorinab. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events. Safety was assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.

Other outcomes

  1. Exploratory - Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Olorinab and Its Metabolites at Week 8

    Time frame: Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose

    The result for this exploratory endpoint was not reported.

  2. Exploratory - Median Time for Cmax (Tmax) of Olorinab and Its Metabolites at Week 8

    Time frame: Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose

    The result for this exploratory endpoint was not reported.

  3. Exploratory - Mean Area Under the Concentration Time Curve From Time of Dosing to 8 Hours Post-dose (AUC0-8) of Olorinab and Its Metabolites at Week 8

    Time frame: Week 0 (Day 1, Day 2), Week 8 (Day -1), Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose

    The result for this exploratory endpoint was not reported.

  4. Exploratory - Mean Change in Abdominal Pain Score (APS) From Trough to Peak at Week 8

    Time frame: Baseline; Week 8

    The result for this exploratory endpoint was not reported.

  5. Exploratory - Change From Baseline in Average APS (AAPS)

    Time frame: Baseline; Week 1, 2, 4, 6 and 8

    The result for this exploratory endpoint was not reported.

  6. Exploratory - Number of Participants Who Were End-of-treatment Responders

    Time frame: Week 8

    The result for this exploratory endpoint was not reported.

  7. Exploratory - Number of Participants Who Were Weekly Responders

    Time frame: Weeks 1, 2, 4, 6, and 8

    The result for this exploratory endpoint was not reported.

  8. Exploratory - Number of Pain-free Days Per Week

    Time frame: Week 1, Week 2, Week 4, Week 6, Week 8, and end of treatment

    The result for this exploratory endpoint was not reported.

  9. Exploratory - Number of Participants Who Used Pain Rescue Medication

    Time frame: Up to Week 8

    The result for this exploratory endpoint was not reported.

  10. Exploratory - Change From Baseline in C-reactive Protein (CRP) Levels at Week 4 and Week 8

    Time frame: Baseline, Week 4, Week 8

    The result for this exploratory endpoint was not reported.

  11. Exploratory - Change From Baseline in Fecal Calprotectin Levels at Week 4 and Week 8

    Time frame: Baseline, Week 4, Week 8

    The result for this exploratory endpoint was not reported.

Sponsors and collaborators

Lead sponsor

Arena Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 16, 2017
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.