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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olorinab 25 mg TID | Experimental | Participants received olorinab 25 milligrams (mg) tablet by mouth, three times daily (TID) for 8 weeks |
|
| Olorinab 100 mg TID | Experimental | Participants received olorinab 100 mg oral tablets TID for 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olorinab | Drug | Olorinab active treatment for 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. | Up to approximately 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Exploratory - Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Olorinab and Its Metabolites at Week 8 | The result for this exploratory endpoint was not reported. | Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose |
| Exploratory - Median Time for Cmax (Tmax) of Olorinab and Its Metabolites at Week 8 |
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Arena CT.gov Administrator | Arena Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research of Brandon | Brandon | Florida | 33511 | United States | ||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33863856 | Derived | Castro J, Garcia-Caraballo S, Maddern J, Schober G, Lumsden A, Harrington A, Schmiel S, Lindstrom B, Adams J, Brierley SM. Olorinab (APD371), a peripherally acting, highly selective, full agonist of the cannabinoid receptor 2, reduces colitis-induced acute and chronic visceral hypersensitivity in rodents. Pain. 2022 Jan 1;163(1):e72-e86. doi: 10.1097/j.pain.0000000000002314. |
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A total of 37 participants were screened for the study. Of these, 23 participants failed screening, and 14 participants were randomized in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olorinab 25 mg TID | Participants received olorinab 25 milligrams (mg) tablet by mouth, three times daily (TID) for 8 weeks |
| FG001 | Olorinab 100 mg TID | Participants received olorinab 100 mg tablet by mouth, TID for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 11, 2017 | Sep 3, 2021 |
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The result for this exploratory endpoint was not reported. |
| Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose |
| 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 | The result for this exploratory endpoint was not reported. | 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 |
| Exploratory - Mean Change in Abdominal Pain Score (APS) From Trough to Peak at Week 8 | The result for this exploratory endpoint was not reported. | Baseline; Week 8 |
| Exploratory - Change From Baseline in Average APS (AAPS) | The result for this exploratory endpoint was not reported. | Baseline; Week 1, 2, 4, 6 and 8 |
| Exploratory - Number of Participants Who Were End-of-treatment Responders | The result for this exploratory endpoint was not reported. | Week 8 |
| Exploratory - Number of Participants Who Were Weekly Responders | The result for this exploratory endpoint was not reported. | Weeks 1, 2, 4, 6, and 8 |
| Exploratory - Number of Pain-free Days Per Week | The result for this exploratory endpoint was not reported. | Week 1, Week 2, Week 4, Week 6, Week 8, and end of treatment |
| Exploratory - Number of Participants Who Used Pain Rescue Medication | The result for this exploratory endpoint was not reported. | Up to Week 8 |
| Exploratory - Change From Baseline in C-reactive Protein (CRP) Levels at Week 4 and Week 8 | The result for this exploratory endpoint was not reported. | Baseline, Week 4, Week 8 |
| Exploratory - Change From Baseline in Fecal Calprotectin Levels at Week 4 and Week 8 | The result for this exploratory endpoint was not reported. | Baseline, Week 4, Week 8 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| MultiCare Institute for Research and Innovation | Tacoma | Washington | 98405 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population: All randomized participants who received at least 1 dose of olorinab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Olorinab 25 mg TID | Participants received olorinab 25 mg tablet by mouth, TID for 8 weeks |
| BG001 | Olorinab 100 mg TID | Participants received olorinab 100 mg tablet by mouth, TID for 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. | Safety Population: All randomized participants who received at least 1 dose of olorinab. | Posted | Count of Participants | Participants | Up to approximately 12 weeks |
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| Other Pre-specified | Exploratory - Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Olorinab and Its Metabolites at Week 8 | The result for this exploratory endpoint was not reported. | Not Posted | Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory - Median Time for Cmax (Tmax) of Olorinab and Its Metabolites at Week 8 | The result for this exploratory endpoint was not reported. | Not Posted | Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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 | The result for this exploratory endpoint was not reported. | Not Posted | 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 | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory - Mean Change in Abdominal Pain Score (APS) From Trough to Peak at Week 8 | The result for this exploratory endpoint was not reported. | Not Posted | Baseline; Week 8 | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory - Change From Baseline in Average APS (AAPS) | The result for this exploratory endpoint was not reported. | Not Posted | Baseline; Week 1, 2, 4, 6 and 8 | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory - Number of Participants Who Were End-of-treatment Responders | The result for this exploratory endpoint was not reported. | Not Posted | Week 8 | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory - Number of Participants Who Were Weekly Responders | The result for this exploratory endpoint was not reported. | Not Posted | Weeks 1, 2, 4, 6, and 8 | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory - Number of Pain-free Days Per Week | The result for this exploratory endpoint was not reported. | Not Posted | Week 1, Week 2, Week 4, Week 6, Week 8, and end of treatment | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory - Number of Participants Who Used Pain Rescue Medication | The result for this exploratory endpoint was not reported. | Not Posted | Up to Week 8 | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory - Change From Baseline in C-reactive Protein (CRP) Levels at Week 4 and Week 8 | The result for this exploratory endpoint was not reported. | Not Posted | Baseline, Week 4, Week 8 | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory - Change From Baseline in Fecal Calprotectin Levels at Week 4 and Week 8 | The result for this exploratory endpoint was not reported. | Not Posted | Baseline, Week 4, Week 8 | Participants |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olorinab 25 mg TID | Participants received olorinab 25 milligrams (mg) oral tablets three times daily (TID) for 8 weeks | 0 | 6 | 0 | 6 | 4 | 6 |
| EG001 | Olorinab 100 mg TID | Participants received olorinab 100 mg oral tablets TID for 8 weeks | 0 | 8 | 1 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | Systematic Assessment |
| |
| Acute interstitial pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Infections and infestations | MedDra 21.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDra 21.0 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDra 21.0 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDra 21.0 | Systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDra 21.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDra 21.0 | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDra 21.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDra 21.0 | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDra 21.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDra 21.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDra 21.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDra 21.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDra 21.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDra 21.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDra 21.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDra 21.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDra 21.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDra 21.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDra 21.0 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDra 21.0 | Systematic Assessment |
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| Injection site extravasation | General disorders | MedDra 21.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDra 21.0 | Systematic Assessment |
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| Blood lactic acid increased | Investigations | MedDra 21.0 | Systematic Assessment |
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| C-reactive protein decreased | Investigations | MedDra 21.0 | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDra 21.0 | Systematic Assessment |
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| Fibrin D dimer increased | Investigations | MedDra 21.0 | Systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | MedDra 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arena CT.gov Administrator | Arena Pharmaceuticals, Inc. | +1 855-218-9153 | ct.gov@arenapharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 27, 2019 | Sep 3, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| C000728614 | olorinab |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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