Clinical trials: Oral Complications
Secondary Hyperparathyroidism, Chronic Kidney Disease
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
The primary objective is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum intact parathyroid hormone (PTH) levels by > 30% from baseline among participants…
- Trial name
- NCT03299244
- Testing
- Etelcalcetide, Cinacalcet
- Where
- 90 sites in China, Hong Kong and 4 more
- Volunteers
- 637 people
- Sponsor
- Amgen
Metrorrhagia
Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.
- Trial name
- NCT00307801
- Testing
- Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)
- Where
- 36 sites in Australia, Czechia and 8 more
- Volunteers
- 231 people
- Sponsor
- Bayer
Peripheral (Sensorimotor) Diabetic Polyneuropathy
To Assess the Bioequivalence of Test Oral Formulation of Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Ilko Ilac San. Ve Tic. A.S. Versus Reference Thioctacid (Alpha Lipoic Acid) 600 mg HR Film Coated Tablets of Meda Pharma GmbH& CO .KG, Germany.
To assess the bioequivalence of test oral formulation of Alpha Lipoic acid 600 mg HR film coated tablets of Ilko Ilac San. Ve Tic. A.S.
- Trial name
- NCT04214665
- Testing
- Alpha Lipoic acid 600 mg HR film coated tablets
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ilko Ilac San. ve Tic. A.S.
Radiotherapy, Immunotherapy
NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy
The 1100 study is an open-label, Phase I, dose escalation and expansion prospective clinical study to assess the safety of intratumoral injection of NBTXR3 activated by radiotherapy in combination with anti-PD-1 therapy.
- Conditions
- Radiotherapy, Immunotherapy, Microsatellite Instability-High Solid Malignant Tumour, Metastasis From Malignant Tumor of Liver
- Trial name
- NCT03589339
- Testing
- NBTXR3, SABR, Nivolumab
- Where
- 13 sites in United States
- Volunteers
- 145 people
- Sponsor
- Nanobiotix
Healthy, Renal Impairment
Comparative Study of Quinine Sulfate in Healthy Patients and in Patients With Renal Impairment
The effects of mild or moderate renal impairment (creatinine clearance 30 to 50 ml/min or >50 to 80 ml/min, respectively) on the pharmacokinetic profile of quinine and its active metabolite, 3'-hydroxyquinine, will be…
- Trial name
- NCT00785551
- Testing
- quinine sulfate
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Post-Operative Pain, Acute Pain
Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
The purpose of the study is to evaluate the efficacy, tolerability, safety and pharmacokinetics of Oxymorphone HCl as an analgesic for acute moderate to severe post-operative pain in pediatric subjects.
- Trial name
- NCT02687451
- Testing
- Oxymorphone HCl
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Diabetic Retinopathy, Diabetic Macular Edema
Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy
The objective of this study is to evaluate the safety and efficacy of APX3330 to treat diabetic retinopathy (DR) and diabetic macular edema (DME).
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema, NPDR - Non Proliferative Diabetic Retinopathy, PDR - Proliferative Diabetic Retinopathy
- Trial name
- ZETA-1 (NCT04692688)
- Testing
- APX3330
- Where
- 24 sites in United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Opus Genetics, Inc
Endometriosis
Visanne Study to Assess Safety in Adolescents
A clinical trial which was designed to demonstrate the safety and efficacy of Visanne (approved in endometriosis for adults) in the adolescent population.
- Trial name
- VISADO (NCT01283724)
- Testing
- Dienogest (Visanne, BAY86-5258)
- Where
- 36 sites in Austria, Czechia and 4 more
- Volunteers
- 111 people
- Sponsor
- Bayer
Neoplasms, Colorectal, Solid Tumor
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors
Solid tumours are abnormal lumps of tissue that can occur in different parts of the body. The tumours involved in this study have specific genetic characteristics that can make them more aggressive and challenging to treat.
- Conditions
- Neoplasms, Colorectal, Solid Tumor, Colon Cancer, Rectal Cancer
- Trial name
- SYLVER (NCT06710847)
- Testing
- GSK4418959, PD-1 inhibitor
- Where
- 22 sites in United States, Australia and 5 more
- Volunteers
- 14 people
- Sponsor
- GlaxoSmithKline
Endometrial Cancer
BEZ235 Trial in Patients With Advanced Endometrial Carcinoma
This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment…
- Trial name
- NCT01290406
- Testing
- BEZ235
- Where
- 59 sites in United States, Brazil and 10 more
- Sponsor
- Novartis Pharmaceuticals
Prevention of Thromboembolic Events
Study to Assess the Safety, Tolerability, Effects on the Body, Absorption, Distribution and Elimination of 25 mg BAY2433334 in Renal Impairment Including Renal Replacement Therapy ("Dialysis")
BAY2433334 is under clinical development for prevention of complications in diseases such as heart attack, irregular heart beat or stroke which can arise by formation of blood clots elsewhere in the body and travels through the…
- Trial name
- NCT04510987
- Testing
- BAY2433334 single dose in treatment groups 1-4 and 6 as well as on the dialysis free day of treatment 5, BAY2433334 on dialysis treatment day
- Where
- Germany
- Volunteers
- 48 people
- Sponsor
- Bayer
Metastatic Renal Cell Carcinoma
RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib
To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.
- Trial name
- RECORD-1 (NCT00410124)
- Testing
- RAD001
- Where
- 93 sites in United States, Australia and 8 more
- Volunteers
- 416 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Cancer, Advanced Solid Tumor
A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.
- Conditions
- Advanced Cancer, Advanced Solid Tumor, Melanoma, Metastasis
- Trial name
- NCT06362369
- Testing
- Alintegimod, Ipilimumab, Nivolumab
- Where
- 5 sites in United States
- Volunteers
- 126 people
- Sponsor
- 7 Hills Pharma, LLC
Candidiasis, Vulvovaginal
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast infection).
- Trial name
- NCT01891331
- Testing
- VT-1161, Fluconazole
- Where
- 8 sites in United States
- Volunteers
- 55 people
- Sponsor
- Viamet
Vulvovaginitis, Candidal, Vulvovaginal Candidiasis
Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.
- Conditions
- Vulvovaginitis, Candidal, Vulvovaginal Candidiasis, Candida Infection, Vaginal Candidiasis
- Trial name
- NCT05908682
- Testing
- Non-interventional study
- Where
- India
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Orthodontic Appliance Complication, Plaque, Dental
Regular Home Use of Dual-light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment
This study is designed to determine the efficacy of the Lumoral method on oral health in adolescents undergoing fixed orthodontic treatment.
- Conditions
- Orthodontic Appliance Complication, Plaque, Dental, Gingival Inflammation
- Trial name
- NCT05825742
- Testing
- Lumoral Treatment, Standard oral health instructions
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- Koite Health Oy
Pulmonary Arterial Hypertension, Renal Dysfunction
The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil
This is a single-center, open-label, single-dose evaluation of 1 mg UT-15C SR pharmacokinetics, safety, and tolerability in subjects with normal, mild, moderate and end stage renal disease (ESRD; on dialysis).
- Trial name
- NCT01131845
- Testing
- UT-15C SR (treprostinil diethanolamine)
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- United Therapeutics
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
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
Autosomal Dominant Polycystic Kidney Disease
A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
This is an exploratory, randomized, double-blind, placebo-controlled, parallel group, multicenter, proof of concept study (Phase 2a), evaluating orally administered GLPG2737 for a double-blind (DB) treatment period of 52 weeks…
- Trial name
- NCT04578548
- Testing
- GLPG2737
- Where
- 20 sites in Belgium, Czechia and 5 more
- Volunteers
- 66 people
- Sponsor
- Lakefront Biotherapeutics NV