Clinical trials: Tolerability
Vaginosis, Bacterial
Safety and Tolerability of Metronidazole Gel 1.3%
Multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal Gel in females 12 to <18 years for the treatment of bacterial vaginosis.
- Trial name
- NCT02392026
- Testing
- Metronidazole Gel
- Where
- 8 sites in United States
- Volunteers
- 60 people
- Sponsor
- Insud Pharma
Fragile X Syndrome
Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001
The subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001 will be offered participation in 22001A which will evaluate secreted protein before and after treatment with STX209 and…
- Trial name
- NCT00823368
- Testing
- STX209
- Where
- 11 sites in United States
- Sponsor
- Seaside Therapeutics, Inc.
Venous Insufficiency
Efficacy and Tolerability CVI (A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial (CVI)
To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms
- Trial name
- NCT00292435
- Testing
- Read vine leaf extract (AS 195)
- Where
- 16 sites in Austria, Czechia and 1 more
- Volunteers
- 202 people
- Sponsor
- Boehringer Ingelheim
Pharyngitis
Ambroxol Lozenges 20mg in Relieving the Pain of Sore Throat in Adolescent Patients With Acute Viral Pharyngitis
The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20mg am broxol hydrochloride relative to placebo in relieving pain of sore throat in adolescent patients suf fering from acute viral…
- Trial name
- NCT00144274
- Testing
- Ambroxol Lozenge
- Where
- 12 sites in South Africa
- Volunteers
- 220 people
- Sponsor
- Boehringer Ingelheim
Mucopolysaccharidosis (MPS)
Safety, Tolerability, Ascending Dose and Dose Frequency Study of rhHNS Via an IDDD in MPS IIIA Patients
Sanfilippo syndrome, or Mucopolysaccharidosis (MPS) III, is a rare lysosomal storage disease (LSD) caused by loss in activity of 1 of 4 enzymes necessary for degradation of the glycosaminoglycan (GAG) heparan sulfate (HS) in…
- Trial name
- NCT01155778
- Testing
- Recombinant human heparan N-sulfatase (rhHNS)
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 12 people
- Sponsor
- Shire
Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Clinical Study on CAR-T Targeting Igβ Targets in Refractory Relapsed Non-Hodgkin's Lymphoma
Aim of this study will evaluate the safety, tolerability and preliminary efficacy of chimeric antigen receptor T cells (CAR-T) targeting Igβ targets in patients with Igβ-positive refractory relapsed non-Hodgkin's lymphoma.
- Trial name
- NCT05312476
- Testing
- Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets
- Where
- China
- Sponsor
- The First Affiliated Hospital of Soochow University
Unresectable Melanoma, Metastatic Melanoma
A Study to Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Unresectable or Metastatic Melanoma Participants In India
The purpose of this study is to assess the safety and tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in unresectable or metastatic melanoma participants in India.
- Trial name
- NCT07459543
- Testing
- Nivolumab + Relatlimab
- Where
- 11 sites in India
- Volunteers
- 40 people
- Sponsor
- Bristol-Myers Squibb
Primary Immunodeficiency Diseases (PID)
A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)
In this study, Japanese participants with primary immunodeficiency diseases were treated with Immune Globulin Subcutaneous (Human), 20% solution, (IGSC, 20%).
- Trial name
- NCT04346108
- Testing
- Immune Globulin Intravenous (IGIV), Immune Globulin Subcutaneous, 20% Solution (IGSC, 20%)
- Where
- 8 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Baxalta now part of Shire
Colorectal Neoplasms, Lung Neoplasms
Figitumumab Combined With Pegvisomant For Advanced Solid Tumors
This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of advanced solid tumors.
- Conditions
- Colorectal Neoplasms, Lung Neoplasms, Breast Neoplasms, Prostatic Neoplasms
- Trial name
- NCT00976508
- Testing
- figitumumab, pegvisomant
- Where
- 5 sites in United States, Canada and 2 more
- Volunteers
- 24 people
- Sponsor
- Pfizer
Pharmacokinetic
Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects
Single center, randomized, double-blinded, placebo-controlled, single ascending-dose study for the evaluation of the safety, tolerability, and PK following single oral doses of INV-101.
- Trial name
- NCT04531150
- Testing
- INV-101
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Inversago Pharma Inc.
Epilepsy
Study in Pediatric Subjects With Epilepsy
This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled partial onset seizures or Lennos-Gastaut syndrome.
- Trial name
- NCT01494584
- Testing
- ezogabine/retigabine
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- GlaxoSmithKline
Neurofibromatosis Type 1
Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN
This study is designed to define a dosing regimen and assess the pharmacokinetics(PK) and safety of the granule formulation; the study will also include descriptive analyses of exploratory efficacy endpoints.
- Trial name
- SPRINKLE (NCT05309668)
- Testing
- Selumetinib granule formulation, Selumetinib capsule formulation
- Where
- 16 sites in United States, Germany and 5 more
- Volunteers
- 36 people
- Sponsor
- AstraZeneca
Relapsing-remitting Multiple Sclerosis
A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)
The main purpose of this study is to evaluate the pharmacokinetics (PK) of ocrelizumab administered subcutaneously (SC) in children and adolescents aged 10 to <18 years with RRMS.
- Trial name
- Operetta III (NCT07503340)
- Testing
- Ocrelizumab co-formulated with rHuPH20
- Volunteers
- 25 people
- Sponsor
- Hoffmann-La Roche
Anthrax
Anthrax-rPA: Safety, Tolerability, Immunogenicity
The primary objective is to determine the tolerability and safety, from days 0 to 210, of escalating doses of rPA either with or without Alhydrogel (an adjuvant; used to increase the action of the principle drug) given in a…
- Trial name
- NCT00063843
- Testing
- Recombinant Protective Antigen, Anthrax Vaccine Adsorbed
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Motavizumab Administration for a Second Season for RSV Prophylaxis
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children
The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children.
- Trial name
- NCT00113490
- Testing
- motavizumab (MEDI-524), palivizumab 15 mg/kg
- Where
- 6 sites in Brazil, Chile
- Volunteers
- 136 people
- Sponsor
- MedImmune LLC
Heterozygous or Homozygous Familial Hypercholesterolemia
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies
The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 (CKJX839C12301)…
- Trial name
- V-PEDS-OLE (NCT05682378)
- Testing
- Inclisiran
- Where
- 52 sites in United States, Argentina and 24 more
- Volunteers
- 195 people
- Sponsor
- Novartis Pharmaceuticals
Dravet Syndrome, Lennox Gastaut Syndrome
A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol
This is an open label study to evaluate the safety of ZX008 (fenfluramine) in patients with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS) who are being administered cannabidiol (CBD).
- Trial name
- NCT03467113
- Testing
- ZX008 0.2 to 0.8 mg/kg/day, Cannabidiol
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Neutropenia, Severe Chronic
ANF-Rho in the Treatment of Chronic Neutropenia
A 6 month safety, tolerability, efficacy and pharmacokinetic study with ANF-Rho to treat patients with chronic neutropenia.
- Trial name
- NCT02533362
- Testing
- ANF-Rho
- Sponsor
- Prolong Pharmaceuticals
Stereotypical Prolonged Seizures
A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.
- Trial name
- NCT05076617
- Testing
- Staccato alprazolam
- Where
- 136 sites in United States, Australia and 10 more
- Volunteers
- 300 people
- Sponsor
- UCB Biopharma SRL
Cystic Fibrosis
A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if deemed appropriate by the Investigators will be…
- Trial name
- CT03Ext (NCT01111383)
- Testing
- tobramycin
- Where
- 20 sites in France, Poland and 1 more
- Volunteers
- 209 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
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