Clinical trials: Adverse Reaction to Drug
HIV Infections
A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV
This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables.
- Trial name
- NCT06970223
- Testing
- Cabotegravir long-acting, Lenacapavir long-acting
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Genetics of Drug Metabolism
Diagnosing Adverse Drug Reactions Registry
This multicenter Registry is to assess whether the use of pharmacogenomic data results in a meaningful change in a subject's drug or dose regimen.
- Trial name
- DART (NCT01970709)
- Where
- 49 sites in United States
- Volunteers
- 250,000 people
- Sponsor
- Renaissance RX
Neuroendocrine Tumors, Carcinoid Syndrome
A Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea
The purpose of the protocol is to to assess subject's overall satisfaction regarding control of diarrhea. The study aims to supplement results obtained through clinical trials with data obtained from a population of patients…
- Trial name
- SYMNET (NCT01234168)
- Where
- 57 sites in Czechia, France and 6 more
- Volunteers
- 340 people
- Sponsor
- Ipsen
Carcinoid Syndrome
Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms
The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.
- Trial name
- TELEPATH (NCT02026063)
- Testing
- Telotristat etiprate
- Where
- 43 sites in United States, Australia and 10 more
- Volunteers
- 124 people
- Sponsor
- Lexicon Pharmaceuticals
Drug Hypersensitivity
A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults
The aim of this study is to find out whether TAK-880 creates hypersensitivity reactions compared to Gammagard S/D by testing blood taken from participants who have a higher risk of becoming hypersensitive to immunoglobulin…
- Trial name
- NCT05269082
- Testing
- No intervention
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Takeda
Parkinson Disease, Dyskinesia, Drug-Induced
Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy
This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day).
- Conditions
- Parkinson Disease, Dyskinesia, Drug-Induced, Dyskinesias
- Trial name
- NCT04857359
- Testing
- Dipraglurant
- Where
- 41 sites in United States
- Volunteers
- 25 people
- Sponsor
- Addex Pharma S.A.
Carcinoid Syndrome
An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males
To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.
- Trial name
- LX1606-104 (NCT01932528)
- Testing
- 500 mg [14C]-LX1606
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Diagnostic Agent Adverse Reaction, Radiation Exposure
18F-LY3950321-01 Biodistribution and Safety Study
18F-LY3950321 (also known as 18F-MNI-1256) is a radiolabeled positron emission tomography (PET) tracer targeting granzyme B. The overall goal of this protocol is to evaluate the safety, tolerability, and radiation dosimetry of…
- Trial name
- NCT05775601
- Testing
- 18F-LY3950321, PET Scan
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Avid Radiopharmaceuticals
Effects, Drug Side
An Investigational Study to Evaluate Experimental Medication SYHX1901 Tablets With Moderate to Severe Plaque Psoriasis
The purpose of this study is to evaluate the efficacy and safety of different doses of SYHX1901 tablets in the treatment of moderate to severe plaque psoriasis in order to select doses for further clinical trials.
- Trial name
- NCT05858047
- Testing
- SYHX1901
- Where
- China
- Volunteers
- 93 people
- Sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
Adverse Reaction
Knowledge and Practices of ADR Reporting in LMICs
The reported literature suggests that knowledge about pharmacovigilance is on a lower side and ADR reporting is not common in developing countries.
- Trial name
- NCT04301219
- Where
- Pakistan
- Volunteers
- 1,500 people
- Sponsor
- Getz Pharma
Cerebral Stroke, Thrombosis, Deep Vein
A Study of Adverse Events and Suspected Adverse Drug Reactions in Patients Under Apixaban for Prevention of Stroke and Systemic Embolism With Non-Valvular Atrial Fibrillation and Venous Thromboembolic Events in Patients Who Have Undergone Elective Hip or Knee Replacement Surgery
To characterize and analyze the number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with Apixaban, according to therapeutic indications approved in Mexico.
- Conditions
- Cerebral Stroke, Thrombosis, Deep Vein, Pulmonary Embolism
- Trial name
- NCT03804125
- Sponsor
- Pfizer
Carcinoid Syndrome
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week…
- Trial name
- NCT01677910
- Testing
- Telotristat etiprate
- Where
- 75 sites in United States, Australia and 10 more
- Volunteers
- 135 people
- Sponsor
- Lexicon Pharmaceuticals
Cytochrome P450 CYP2D6 Enzyme Deficiency, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant
Drug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM
This randomized controlled trial will evaluate whether the use of pharmacogenetic testing through a Medication Therapy Management (MTM) program has a beneficial impact on drug therapy problems.
- Conditions
- Cytochrome P450 CYP2D6 Enzyme Deficiency, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Extensive Metabolizer Due to Cytochrome P450 CYP2D6 Variant
- Trial name
- NCT02428660
- Testing
- Pharmacogenetic testing, Software-based drug & gene interaction risk analysis, MTM
- Where
- United States
- Volunteers
- 341 people
- Sponsor
- Genelex Corporation
Carcinoid Syndrome, Carcinoid
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
A Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of paltusotine treatment vs placebo as well as the long-term safety of paltusotine in adults with carcinoid syndrome due to…
- Conditions
- Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum
- Trial name
- CAREFNDR (NCT07087054)
- Testing
- Paltusotine
- Where
- 72 sites in United States, Argentina and 12 more
- Volunteers
- 141 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
Drug Toxicity
Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100
Arm 1: Primary Objective: To determine the safety and tolerability of multiple ascending, supratherapeutic doses of HPN-100. Arm 2: Primary Objective: To assess the effects of steady-state levels of HPN-100 metabolites (4…
- Trial name
- NCT01135680
- Testing
- HPN-100, Moxifloxacin
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Amgen
Drug Toxicity
Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics of KD101 in Healthy Male Subjects
To Evaluate the safety and tolerability after KD101 single oral dosing in healthy male subjects To Evaluate the pharmacokinetic property after KD101 single oral dosing in healthy male subjects To Evaluate the effect of food on…
- Trial name
- NCT01979380
- Testing
- KD101
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Kwang Dong Pharmaceutical co., ltd.
Drug-Induced Liver Injury, Cholestatic Liver Injury
A Randomized,Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MT2004 Capsule in DILI Subjects
The goal of this randomized, double-blind, placebo controlled, Multicenter Phase II clinical trial is to initially evaluate the Safety and Efficacy of MT2004 Capsule in Cholestatic and Mixed drug induced liver injury (DILI)…
- Conditions
- Drug-Induced Liver Injury, Cholestatic Liver Injury, Mixed Liver Injury
- Trial name
- NCT06019936
- Testing
- MT2004 Capsule
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Xi'An Aolitai Pharmaceutical Technology Co Ltd
Tumor Infiltrating Lymphocytes, Safety
A Study of GC101 TIL in Advanced Melanoma (BZ)
20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 20 months.
- Conditions
- Tumor Infiltrating Lymphocytes, Safety, Melanoma, Efficacy
- Trial name
- MIZAR-002 (NCT06120712)
- Testing
- GC101 TIL
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Shanghai Juncell Therapeutics
Influenza
Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)
The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillance of seasonal influenza vaccines in the…
- Trial name
- NCT02567721
- Testing
- Vaccine safety surveillance
- Where
- United Kingdom
- Volunteers
- 11,530 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Asthma, Aspirin-Induced
Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)
The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD).
- Trial name
- NCT03028350
- Testing
- Ifetroban Oral Capsule
- Where
- 16 sites in United States
- Volunteers
- 54 people
- Sponsor
- Cumberland Pharmaceuticals