We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    APD-371
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
Verified May 2017 by Arena Pharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT03155945
First Posted: May 16, 2017
Last Update Posted: May 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Arena Pharmaceuticals
  Purpose
The purpose of this randomized, open-label, parallel, phase 2a study is to determine the tolerability, pharmacokinetics, and efficacy of APD371 in subjects with Crohn's disease experiencing abdominal pain.

Condition Intervention Phase
Crohn's Disease Abdominal Pain Drug: APD371 Phase 2

Study Type: Interventional
Study Design: 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 Subjects With Crohn's Disease Experiencing Abdominal Pain

Resource links provided by NLM:


Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:
  • Number of patients with adverse events and abnormal clinical laboratory tests (including hematology, serum chemistry, coagulation and urinalysis). [ Time Frame: up to 8 weeks ]
    Tolerability and safety of two doses of APD371 in subjects with Crohn's Disease experiencing abdominal pain


Secondary Outcome Measures:
  • Change in peak plasma concentration (Cmax) [ Time Frame: up to 8 weeks ]
  • Change in time to Cmax (Tmax) [ Time Frame: up to 8 weeks ]
  • Change in area under the plasma concentration versus time curve (AUC) [ Time Frame: up to 8 weeks ]
  • Change in abdominal pain score (APS) [ Time Frame: up to 8 weeks ]
    From pre-dose (trough) to 1.5 hr post-dose (peak) following the first of 3 daily doses of APD371; assessed daily to Day 56

  • Change in average APS (AAPS) [ Time Frame: up to 8 weeks ]
    From Screening and averaged weekly to week 8

  • Proportion of subjects who are end-of-treatment responders [ Time Frame: up to 8 weeks ]
  • Proportion of subjects who are weekly responders [ Time Frame: up tp 8 weeks ]
  • Number of pain-free days per week in each treatment cohort, based on responses to the APS [ Time Frame: up to 8 weeks ]
  • Frequency of pain rescue medication use in each treatment cohort [ Time Frame: up to 8 weeks ]
  • Effect of APD371 treatment on reduction in C-reactive protein (CRP) levels at week 4 and week 8 [ Time Frame: up to 8 weeks ]
  • Effect of APD371 treatment on reduction in fecal calprotectin levels at week 4 and week 8 [ Time Frame: up to 8 weeks ]

Estimated Enrollment: 20
Actual Study Start Date: May 18, 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APD371 low dose treatment Drug: APD371
APD371 active treatment for 8 weeks.
Experimental: APD371 high dose treatment Drug: APD371
APD371 active treatment for 8 weeks.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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 SES-CD score of < 6 or ileal SES-CD < 4 or FCP < 300 mcg/g at screening.
  • Moderate to severe abdominal pain as defined by AAPS of >5 points 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 subjects 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.

  Contacts and Locations
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


Contacts
Contact: Chad Orevillo, MPH +1 8584537200 corevillo@arenapharm.com

Locations
United States, New Jersey
Hassman Research Institute Recruiting
Berlin, New Jersey, United States, 08009
Contact: Michael Hassman, MD         
Sponsors and Collaborators
Arena Pharmaceuticals
  More Information

Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03155945     History of Changes
Other Study ID Numbers: APD371-004
First Submitted: May 11, 2017
First Posted: May 16, 2017
Last Update Posted: May 24, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Crohn Disease
Abdominal Pain
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive


To Top