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

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ClinicalTrials.gov Identifier: NCT03155945
Recruitment Status : Completed
First Posted : May 16, 2017
Results First Posted : November 2, 2021
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Abdominal Pain Drug: Olorinab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 19, 2017
Actual Primary Completion Date : September 10, 2018
Actual Study Completion Date : September 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Olorinab 25 mg TID
Participants received olorinab 25 milligrams (mg) tablet by mouth, three times daily (TID) for 8 weeks
Drug: Olorinab
Olorinab active treatment for 8 weeks.
Other Name: APD371

Experimental: Olorinab 100 mg TID
Participants received olorinab 100 mg oral tablets TID for 8 weeks
Drug: Olorinab
Olorinab active treatment for 8 weeks.
Other Name: APD371




Primary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155945


Locations
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United States, Florida
Clinical Research of Brandon
Brandon, Florida, United States, 33511
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Hassman Research Institute
Berlin, New Jersey, United States, 08009
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
United States, Washington
MultiCare Institute for Research and Innovation
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
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Study Director: Arena CT.gov Administrator Arena Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Arena Pharmaceuticals:
Study Protocol  [PDF] August 11, 2017
Statistical Analysis Plan  [PDF] March 27, 2019

Additional Information:
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Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03155945    
Other Study ID Numbers: APD371-004
First Posted: May 16, 2017    Key Record Dates
Results First Posted: November 2, 2021
Last Update Posted: November 2, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Abdominal Pain
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive