Clinical trials: Oral Complications
Sickle Cell Disease
PASS of Xromi Comparing Safety and Effectiveness in Children Under 2 Years With Sickle Cell Disease [PRECISE PASS]
This post-authorisation safety and efficacy study (PRECISE PASS) evaluates the use of Xromi® (hydroxycarbamide 100 mg/mL oral solution) in children aged 9 months to under 2 years with sickle cell disease (SCD).
- Trial name
- PRECISE (NCT06923111)
- Testing
- Xromi
- Where
- 12 sites in Germany, United Kingdom
- Volunteers
- 180 people
- Sponsor
- Nova Laboratories Limited
Polycystic Ovary Syndrome (PCOS)
Efficacy and Safety of DLBS3233 in Subjects With Polycystic Ovary Syndrome (PCOS)
This is a 2-arm, randomized, double-blind, double-dummy, and controlled clinical study, with 6 months of treatment to evaluate the clinical and metabolic efficacy of DLBS3233 in improving reproductive parameters and to evaluate…
- Trial name
- NCT01733459
- Testing
- DLBS3233, Metformin XR
- Where
- 2 sites in Indonesia
- Volunteers
- 124 people
- Sponsor
- Dexa Medica Group
Age-Related Macular Degeneration, Allergies
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and…
- Conditions
- Age-Related Macular Degeneration, Allergies, Alpha-Gal Syndrome, Alzheimer Disease
- Trial name
- NCT05635266
- Testing
- Specimen sample
- Where
- United States
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Sanguine Biosciences
Diabetic Nephropathies
Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy
To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy.
- Trial name
- ARTS-DN (NCT01874431)
- Testing
- Finerenone (BAY94-8862)
- Where
- 147 sites in United States, Australia and 21 more
- Volunteers
- 823 people
- Sponsor
- Bayer
Chronic Kidney Disease
Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease
This study explores the use of KBP-5074 in patients with advanced stages of Chronic Kidney Disease (CKD) (including patients with severe renal impairment and those on hemodialysis [HD]) and to assess the safety, tolerability, and…
- Trial name
- NCT02837237
- Testing
- KBP-5074
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- KBP Biosciences
Solid Tumors, CNS Tumors
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain…
- Trial name
- STARTRK-NG (NCT02650401)
- Testing
- Entrectinib
- Where
- 26 sites in United States, Canada and 7 more
- Volunteers
- 69 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers, Impaired Renal Function
RI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Renal Impaired Patients and Healthy Subjects
This is a Phase 1, multicentric, open-label,two arms to assess and compare the effect of single oral administration of MD1003 on the pharmacokinetic parameters in renal impaired patients and healthy subjects with normal renal…
- Trial name
- NCT04252430
- Testing
- MD1003
- Where
- 5 sites in France, Hungary
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- MedDay Pharmaceuticals SA
Renal Impairment, Healthy Volunteers
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
The purpose of this Phase 1, open-label, 2-arm study is to assess the effect of severe RI on PK, safety, and tolerability of rilzabrutinib compared with normal renal function, in male and female participants aged from 18 to 75…
- Trial name
- NCT07853131
- Testing
- rilzabrutinib
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sanofi
Endometriosis
BGS649 Monotherapy in Moderate to Severe Endometriosis Patients
This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.
- Trial name
- NCT01190475
- Testing
- Active treatment with a high dose of BGS649, Active treatment with a low dose of BGS649
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Mereo BioPharma
Chronic Renal Insufficiency
Pharmacokinetic Parameters of Stiripentol in Renal Impaired Patients and Matching Controls With Normal Renal Function
The purpose of this study is to determine whether the pharmacokinetics (PK) of stiripentol and of its relevant metabolites would be altered in subjects with renal impairment compared with normal controls in order to assess the…
- Trial name
- STP237 (NCT05735951)
- Testing
- STIRIPENTOL oral administration
- Where
- Bulgaria
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Biocodex
Diabetic Retinopathy
A Study That Tests BI 1467335 in Patients With Diabetic Eye Disease (Diabetic Retinopathy). It Looks at the Way BI 1467335 is Taken up, the Effects it Has, and How Well it is Tolerated.
The main objective is to evaluate ocular and systemic safety and tolerability of BI 1467335 as well as whether BI 1467335 monotherapy has a potential to improve retinal lesions in patients with moderately severe Non-proliferative…
- Trial name
- ROBIN (NCT03238963)
- Testing
- BI 1467335
- Where
- 35 sites in United States, Austria and 6 more
- Volunteers
- 79 people
- Sponsor
- Boehringer Ingelheim
Renal Impairment
Study of GBT021601 in Participants With Renal Impairment
Renal Impairment study of GBT021601.
- Trial name
- NCT05878704
- Testing
- GBT021601
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pfizer
Renal Impairment, Healthy Volunteers
A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys
It is hoped that mobocertinib will eventually help people with cancer with severely reduced kidney function. The main aim of this study is to learn about the levels of mobocertinib in the blood and urine of participants with…
- Trial name
- NCT04056455
- Testing
- Mobocertinib
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Depression, Postpartum, Depression, Post-Partum
A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD
The purpose of this research study is to test the study drug, LPCN 1154A, as a possible treatment for postpartum depression (PPD).
- Conditions
- Depression, Postpartum, Depression, Post-Partum, Postpartum Depression (PPD), Post-Natal Depression
- Trial name
- NCT06979544
- Testing
- LPCN 1154A
- Where
- 18 sites in United States
- Volunteers
- 90 people
- Sponsor
- Lipocine Inc.
Obstetric Labour, Premature
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor.
- Trial name
- NCT00404768
- Testing
- GSK221149A
- Where
- 57 sites in United States, Argentina and 9 more
- Volunteers
- 93 people
- Sponsor
- GlaxoSmithKline
Premature Birth of Newborn
Oral Formulation of Insulin for Preterm Infants
The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.
- Trial name
- NCT01093638
- Testing
- Oral Formulation of Insulin
- Where
- Israel
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Elgan Pharma Ltd.
Chronic Kidney Disease
Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I Treatment
Primary Objective: To assess the tolerability and safety of repeated oral ascending doses of SAR407899A in patients with moderate chronic kidney disease (CKD) on stable angiotensin converting enzyme-inhibitor (ACE-I) Secondary…
- Trial name
- NCT01485900
- Testing
- SAR407899A
- Where
- 2 sites in Moldova, Romania
- Volunteers
- 20 people
- Sponsor
- Sanofi
Hyperkalemia
Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia
The purpose of this study is to evaluate the change in serum potassium levels from start of treatment to Day 14, when patiromer is administered at different doses, once daily, in children 2 - < 18 years of age with chronic kidney…
- Trial name
- EMERALD (NCT03087058)
- Testing
- Patiromer
- Where
- 30 sites in United States, Bulgaria and 5 more
- Volunteers
- 23 people
- Sponsor
- Vifor Pharma, Inc.
Depression, Postpartum, Postpartum Depression (PPD)
Brexanolone Lifting Outcomes Of Moms
The purpose of this research study is to test the study drug, LPCN 1154A, as a possible treatment for postpartum depression (PPD).
- Conditions
- Depression, Postpartum, Postpartum Depression (PPD), Post-partum Depression, Postnatal Depression
- Trial name
- BLOOM (NCT07822321)
- Testing
- LPCN 1154A
- Where
- 16 sites in United States
- Volunteers
- 120 people
- Sponsor
- Lipocine Inc.
Postoperative Pain
An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain
The primary objective of this study is to characterize the pharmacokinetics and pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.
- Trial name
- Palladone (NCT00465647)
- Testing
- Hydromorphone
- Where
- 14 sites in United States
- Volunteers
- 116 people
- Sponsor
- Purdue Pharma LP