Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004211-40 | EudraCT Number |
Not provided
Not provided
Not provided
No longer pursuing development of serlopitant
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study of the long term safety of serlopitant for the treatment of pruritus in adults.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: 5 mg Serlopitant Tablets | Experimental | Serlopitant Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 mg Serlopitant Tablets | Drug | Serlopitant Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Treatment-emergent Adverse Events | Treatments emergent adverse events (TEAEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected. | From baseline until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 52 visit or the last dose of study drug for subjects who discontinued study drug early. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site 504 | Birmingham | Alabama | 35233 | United States | ||
| Study Site 204 |
Subjects attended a screening visit before receiving their first dose. All subjects underwent inclusion exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study-related procedures.
The study was conducted at 120 sites from 15 March 2018 to 08 April 2020. All participants who met the study entry criteria received daily oral doses of serlopitant 5 mg tablet.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Serlopitant 5 mg | Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2019 | Oct 28, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fremont |
| California |
| 94538 |
| United States |
| Study Site 383 | North Hollywood | California | 91606 | United States |
| Study Site 356 | San Diego | California | 92108 | United States |
| Study Site 514 | Santa Ana | California | 92701 | United States |
| Study Site 501 | Aventura | Florida | 33180 | United States |
| Study Site 210 | Coral Gables | Florida | 33134 | United States |
| Study Site 534 | Fort Lauderdale | Florida | 33316 | United States |
| Study Site 531 | Miami | Florida | 33155 | United States |
| Study Site 222 | North Miami Beach | Florida | 33162 | United States |
| Study Site 510 | Newnan | Georgia | 30263 | United States |
| Study Site 388 | Skokie | Illinois | 60077 | United States |
| Study Site 228 | Louisville | Kentucky | 40202 | United States |
| Study Site 527 | New Orleans | Louisiana | 70115 | United States |
| Study Site 525 | Glenn Dale | Maryland | 20769 | United States |
| Study Site 506 | Ann Arbor | Michigan | 48103 | United States |
| Study Site 515 | Detroit | Michigan | 48202 | United States |
| Study Site 371 | Saint Joseph | Missouri | 64506 | United States |
| Study Site 528 | St Louis | Missouri | 63110 | United States |
| Study Site 227 | Omaha | Nebraska | 68144 | United States |
| Study Site 526 | Henderson | Nevada | 89052 | United States |
| Study Site 201 | East Windsor | New Jersey | 08520 | United States |
| Study Site 529 | Verona | New Jersey | 07044-2946 | United States |
| Study Site 507 | Brooklyn | New York | 11203 | United States |
| Study Site 508 | Buffalo | New York | 14221 | United States |
| Study Site 500 | New York | New York | 10025 | United States |
| Study Site 517 | New York | New York | 10075 | United States |
| Study Site 341 | High Point | North Carolina | 27262 | United States |
| Study Site 516 | Bexley | Ohio | 43209 | United States |
| Study Site 509 | Cleveland | Ohio | 44106 | United States |
| Study Site 524 | Dublin | Ohio | 43016 | United States |
| Study Site 112 | Tulsa | Oklahoma | 74136 | United States |
| Study Site 523 | Philadelphia | Pennsylvania | 19104 | United States |
| Study Site 522 | Pittsburgh | Pennsylvania | 15213 | United States |
| Study Site 345 | Johnston | Rhode Island | 02919 | United States |
| Study Site 343 | Spartanburg | South Carolina | 29303 | United States |
| Study Site 511 | Knoxville | Tennessee | 37317 | United States |
| Study Site 365 | Austin | Texas | 78745 | United States |
| Study Site 520 | Bellaire | Texas | 77401 | United States |
| Study Site 502 | Dallas | Texas | 75231 | United States |
| Study Site 224 | Houston | Texas | 77004 | United States |
| Study Site 359 | Pflugerville | Texas | 78660 | United States |
| Study Site 226 | Webster | Texas | 77598 | United States |
| Study Site 336 | Richmond | Virginia | 23220 | United States |
| Study Site 806 | Spokane | Washington | 99202 | United States |
| Study Site 532 | Morgantown | West Virginia | 26505 | United States |
| Study Site 649 | Graz | 8036 | Austria |
| Study Site 648 | Linz | 4020 | Austria |
| Study Site 650 | Vienna | 1130 | Austria |
| Study Site 623 | Bad Bentheim | 48455 | Germany |
| Study Site 607 | Berlin | 10117 | Germany |
| Study Site 641 | Berlin | 10783 | Germany |
| Study Site 600 | Bielefeld | 33647 | Germany |
| Study Site 617 | Bochum | 44793 | Germany |
| Study Site 608 | Bonn | 53127 | Germany |
| Study Site 642 | Buxtehude | 21614 | Germany |
| Study Site 606 | Dresden | 01307 | Germany |
| Study Site 621 | Erlangen | 91054 | Germany |
| Study Site 602 | Frankfurt am Main | 60590 | Germany |
| Study Site 639 | Hamburg | 22391 | Germany |
| Study Site 605 | Heidelberg | 69115 | Germany |
| Study Site 611 | Leipzig | 04103 | Germany |
| Study Site 620 | Mahlow | 15831 | Germany |
| Study Site 614 | Mainz | 55131 | Germany |
| Study Site 601 | Münster | 48149 | Germany |
| Study Site 618 | Osnabrück | 49074 | Germany |
| Study Site 615 | Selters | 56242 | Germany |
| Study Site 643 | Stuttgart | 70178 | Germany |
| Study Site 636 | Bydgoszcz | 85-065 | Poland |
| Study Site 628 | Iwonicz-Zdrój | 38-440 | Poland |
| Study Site 633 | Krakow | 30-033 | Poland |
| Study Site 624 | Krakow | 31-070 | Poland |
| Study Site 635 | Krakow | 31-209 | Poland |
| Study Site 629 | Lodz | 90-436 | Poland |
| Study Site 631 | Olsztyn | 10-900 | Poland |
| Study Site 625 | Osielsko | 86-031 | Poland |
| Study Site 645 | Poznan | 60-214 | Poland |
| Study Site 644 | Poznan | 60-848 | Poland |
| Study Site 634 | Rzeszów | 35-055 | Poland |
| Study Site 638 | Szczecin | 70-332 | Poland |
| Study Site 632 | Torun | 87-100 | Poland |
| Study Site 627 | Warsaw | 02-758 | Poland |
| Study Site 637 | Wroclaw | 50-566 | Poland |
| Study Site 630 | Wroclaw | 53-301 | Poland |
| Study Site 647 | Wroclaw | 53-658 | Poland |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Nine subjects were excluded from the safety population (all from US) due to no evidence of subject dosing and/or no post-Baseline assessment/treatment emergent adverse event.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Serlopitant 5 mg | Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 Subjects With Treatment-emergent Adverse Events | Treatments emergent adverse events (TEAEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected. | Safety population: included all treated participants with at least one postbaseline assessment or a reported TEAE. No statistical analyses were performed for this end point | Posted | Count of Participants | Participants | From baseline until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 52 visit or the last dose of study drug for subjects who discontinued study drug early. |
|
|
|
From baseline until the F/U visit which occurred 35 days (+ 7 days) after the Week 52 visit or the last dose of study drug for subjects who discontinued study drug early
Subjects received serlopitant 5 mg tablet once daily orally.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Serlopitant 5 mg | Subjects received serlopitant 5 mg tablet once daily orally from Baseline Visit (Study Day 1) until the Week 52 Visit. | 0 | 549 | 45 | 549 | 36 | 549 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial occlusive disease | Vascular disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Hernia hiatus repair | Surgical and medical procedures | MedDRA 21.1 | Non-systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 21.1 | Non-systematic Assessment |
| |
| Adjustment disorder with anxiety | Psychiatric disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Non-systematic Assessment |
| |
| Craniofacial fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Non-systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 21.1 | Non-systematic Assessment |
| |
| Anticoagulation drug level below | Investigations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Ventricular asystole | Cardiac disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Neurodegenerative disorder | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Corneal perforation | Eye disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Pancreatic disorder | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Abscess jaw | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
|
Due to a corporate decision to no longer pursue an indication of treatment for pruritus, and further to terminate the development program for serlopitant, the study was terminated prematurely.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Iain Stuart, PhD | Menlo Therapeutics, Inc. | 1-800-775-7936 | Iain.Stuart@foamix.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 12, 2020 | Oct 28, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011537 | Pruritus |
| D003876 | Dermatitis, Atopic |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017444 | Skin Diseases, Papulosquamous |
Not provided
Not provided
| ID | Term |
|---|---|
| C551592 | serlopitant |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Subjects with any related SAE |
|
| Subjects who died |
|
| Subjects who discontinued study drug due to TEAE |
|