Clinical trials: Oral Complications
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.
Vulvovaginal Candidiasis
Oral Lactobacillus Crispatus Lc-G22 as Adjunctive Therapy for Vulvovaginal Candidiasis
This single-center, randomized, single-blind, placebo-controlled trial aimed to evaluate the efficacy and safety of oral Lactobacillus crispatus Lc-G22 as adjunctive therapy to clotrimazole for preventing recurrence of…
- Trial name
- NCT07727967
- Testing
- Lactobacillus crispatus Lc-G22
- Where
- China
- Volunteers
- 100 people
- Sponsor
- BioGrowing Co., Ltd
Endometriosis
Study to Evaluate the Pharmacodynamics and Efficacy of Leuprolide Tablets (Ovarest®) in Women With Endometriosis
The pharmacodynamic endpoint of percentage of subjects with suppressed estradiol level (less than 20 pg/mL) on cycle day 29 is the primary endpoint of the study.
- Trial name
- NCT05096065
- Testing
- Leuprolide Oral Tablet - 120 mg - QD- Treatment A, Leuprolide Oral Tablet - 80 mg - QD - Treatment B, Leuprolide Oral Tablet - 60 mg - QD - Treatment C
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- Enteris BioPharma Inc.
Endometriosis, Uterine Fibroids
A Trial of SHR7280 in Healthy Subjects
The study is being conducted to evaluate the effect of high-fat meal on pharmacokinetics of SHR7280 after oral administration and the effect of SHR7280 on QT interval at low and high doses in healthy Chinese volunteers.
- Conditions
- Endometriosis, Uterine Fibroids, Assisted Reproduction
- Trial name
- NCT06969664
- Testing
- SHR7280 Tablet
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Ovarian Neoplasms, Non-Small-Cell Lung Carcinoma
A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers.
A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway alterations.
- Conditions
- Ovarian Neoplasms, Non-Small-Cell Lung Carcinoma, Melanoma, Other Solid Tumors
- Trial name
- NCT02711345
- Testing
- LTT462
- Where
- 7 sites in United States, Germany and 4 more
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
Cancer
RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma
RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread.
- Trial name
- NCT00101972
- Testing
- monoclonal antibody RAV12
- Where
- 5 sites in United States
- Volunteers
- 53 people
- Sponsor
- MacroGenics
Renally Impaired Subjects
Single-dose Pharmacokinetics and Safety of Oral Lofexidine in Renally-Impaired Subjects
This is a phase 1, open-label, parallel-group, single-dose study of lofexidine in 8 adult subjects with ESRD maintained on hemodialysis (3 times per week) and 8 control subjects with normal renal function, recruited as 1:1…
- Trial name
- NCT02313103
- Testing
- lofexidine HCl
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
Advanced Solid Tumors, Selected Solid Tumors
Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients
This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor…
- Trial name
- NCT01363232
- Testing
- BKM120 + MEK162
- Where
- 12 sites in United States, Canada and 5 more
- Volunteers
- 89 people
- Sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
GENITAL HERPES
Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms, such as…
- Trial name
- NCT01281007
- Testing
- Famciclovir, Aciclovir
- Where
- 9 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- EMS
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
Overactive Bladder
A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder.
1. Primary Objective: To evaluate the dose-response relationship of tarafenacin on efficacy. 2. Secondary Objectives: To compare 12 weeks' efficacy of different doses of tarafenacin to that of placebo in patients suffering from…
- Trial name
- NCT01458197
- Testing
- Tarafenacin 0.2 mg, Tarafenacin 0.4 mg
- Where
- South Korea
- Volunteers
- 235 people
- Sponsor
- Kwang Dong Pharmaceutical co., ltd.
Fabry Disease
Safety and Effect of Oral RVX000222 in Subjects With Fabry Disease
Fabry Disease (FD) is a rare X-linked lysosomal storage disorder (LSD) caused by mutations in the GLA gene which translates into decreased activity or lack of function of the enzyme alpha-galactosidase A (α-GAL A) and…
- Trial name
- NCT03228940
- Testing
- RVX000222
- Where
- Canada
- Sponsor
- Resverlogix Corp
Venous Thromboembolism
Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs
To assess the safety and pharmacokinetics of DU-176b administered to patients with severe renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b administered to patients with mild renal…
- Trial name
- NCT01857583
- Testing
- 15mg DU-176b, 30mg DU-176b, Fondaparinux
- Where
- Japan
- Volunteers
- 80 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Endometriosis
Study on the Safety of the Drug BAY2395840 at Different Doses, the Way the Body Absorbs, Distributes and Excretes the Drug Including the Effect of Its Formulation (Tablet or Liquid) and the Effect of Food on the Absorption, Distribution or Excretion of the Drug in Healthy Male Participants
Researchers are looking for a better way to treat people who have endometriosis, a condition in which tissue similar to the lining of the uterus starts to grow in places outside of the uterus.
- Trial name
- NCT05517746
- Testing
- BAY2395840 tablet, BAY2395840 oral solution
- Where
- Germany
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Bayer
Anemia Associated With Chronic Kidney Disease (CKD)
Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of…
- Trial name
- NCT04707768
- Testing
- Vadadustat, Mircera®
- Where
- 58 sites in United States
- Volunteers
- 456 people
- Sponsor
- Akebia Therapeutics
Urinary Tract Infections, Bacteriuria
A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Complicated Urinary Tract Infections
The purpose of the study is to compare the safety and effectiveness of oral levofloxacin (an antibiotic) with that of oral ciprofloxacin in the treatment of complicated urinary tract infections in adults.
- Conditions
- Urinary Tract Infections, Bacteriuria, Urologic Diseases, Pyelonephritis
- Trial name
- NCT00258089
- Testing
- Levofloxacin
- Volunteers
- 578 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Non-Muscle Invasive Bladder Cancer (NMIBC)
Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction Course of BCG Treatment
A Phase Ib, open label, non randomized study to measure the safety and PK characteristics of APL-1202 at steady-state in adult male and female BCG resistant NMIBC patients when it is administered alone and concurrently with BCG.
- Trial name
- NMIBC (NCT03672240)
- Testing
- APL-1202
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Asieris Pharmaceutical Technologies Co., Ltd.
Renal Impairment, Healthy Volunteers
A Study of TAK-279 in Adults With or Without Kidney Problems
The main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with kidney problems compared to participants without kidney problems.
- Trial name
- NCT05992155
- Testing
- TAK-279
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Endometriosis
Study to Test the Safety of Increasing Multiple Doses of BAY2328065 Given by Mouth, How the Drug is Tolerated and Acts in the Human Body of Healthy Male Participants. Alteration of the Study Drug Effects by Another Drug and the Availability of the Drug Given in Different Formulations is Also Tested.
Study on the safety and tolerability of a new drug BAY2328065 when given increased doses as tablet or solution over 12 days to healthy male participants.
- Trial name
- NCT04027192
- Testing
- BAY2328065 LSF, BAY2328065 tablet, Midazolam
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Bayer
Endometriosis
A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis
The purpose of this study is to compare the long term safety and efficacy of TAK-385, once daily (QD) following continued administration in participants who completed a Phase II dose-finding study.
- Trial name
- NCT01452685
- Testing
- TAK-385, Leuprorelin acetate
- Where
- 69 sites in Japan
- Volunteers
- 397 people
- Sponsor
- Takeda