Clinical trials: Oral Complications
Metrorrhagia
An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With Norgestimate/Ethinyl Estradiol Tablets Administered as an Extended Regimen
The purpose of this study is to evaluate the bleeding profile of norgestimate/ethinyl estradiol, an oral contraceptive tablet, given in an extended regimen
- Trial name
- NCT00344383
- Testing
- Norgestimate/Ethinyl Estradiol tablet
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Osteoarthritis, Pain
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of iN1011-N17 after Oral Administration in Healthy Volunteers.
- Conditions
- Osteoarthritis, Pain, Post Herpetic Neuralgia, Neuropathic Pain
- Trial name
- NCT05496205
- Testing
- iN1011-N17
- Where
- Australia
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- iN Therapeutics Co., Ltd.
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
Advanced Solid Tumor, High Grade Serous Adenocarcinoma of Ovary
A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer
This is a first-in-human phase I/II study to examine the safety, tolerability and preliminary efficacy of VLS-1488 in subjects with advanced cancers.
- Conditions
- Advanced Solid Tumor, High Grade Serous Adenocarcinoma of Ovary, Squamous Non-small-cell Lung Cancer, Triple Negative Breast Cancer
- Trial name
- NCT05902988
- Testing
- VLS-1488
- Where
- 14 sites in United States
- Volunteers
- 200 people
- Sponsor
- Volastra Therapeutics, Inc.
Pain
Drug Interactions Between Morphine and Orally or IV Administered Acetaminophen
Morphine is the opioid used to treat pain after surgery. Acetaminophen (called APAP) can reduce the amount of opioids needed for this. The problem is that morphine slows down digestion. That can delay pain relief from APAP pills.
- Trial name
- NCT02848729
- Testing
- Oral Acetaminophen, IV Acetaminophen, IV Morphine
- Where
- 3 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
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
Endometriosis
TUC3PII-01_TU2670 Phase IIa Clinical Study
This Protocol for TU2670 is to investigate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of TU2670 in subjects with moderate to severe endometriosis-associated pain.
- Trial name
- NCT05138562
- Testing
- Active Comparator: TU2670 320mg, Active Comparator: TU2670 240mg, Active Comparator: TU2670 120mg
- Where
- 40 sites in Czechia, Italy and 3 more
- Volunteers
- 86 people
- Sponsor
- TiumBio Co., Ltd.
Painful Diabetic Neuropathy
An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy
The primary objective of the trial is to assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy.
- Trial name
- NCT00861042
- Testing
- SPM927/Lacosamide
- Volunteers
- 69 people
- Sponsor
- UCB Pharma
Renal Insufficiency, Chronic, Iron-Deficiency Anemia
Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD
- Trial name
- AEGIS-CKD (NCT02968368)
- Testing
- Ferric maltol
- Where
- 27 sites in United States
- Volunteers
- 167 people
- Sponsor
- Shield Therapeutics
Diabetic Kidney Disease
A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients
The study will be a single center, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to Diabetic Kidney Disease patients.
- Trial name
- NCT06666283
- Testing
- AP303 150μg
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Alebund Pharmaceuticals
Recurrent Vulvovaginal Candidiasis
A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months.
- Trial name
- VIOLET (NCT03561701)
- Testing
- Oteseconazole (VT-1161)
- Where
- 14 sites in United States
- Volunteers
- 425 people
- Sponsor
- Mycovia Pharmaceuticals Inc.
Chronic Kidney Disease
A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia
The objective of this study is to evaluate the efficacy and the safety when ASP1517 is intermittently administered in Erythropoiesis Stimulating Agent (ESA)-untreated non-dialysis chronic kidney disease patients with anemia.
- Trial name
- NCT02964936
- Testing
- roxadustat
- Where
- 38 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Astellas Pharma Inc
Overactive Bladder(OAB)
The Safety and PK Characteristics of the Co-administration of JLP-2002 and Comparator in Healthy Volunteers
A randomized, open-label, single-dose, replicate crossover study to compare the pharmacokinetics and safety in healthy adult volunteers following oral administration of JLP-2002
- Trial name
- NCT04914221
- Testing
- JLP-2002, Comparator
- Where
- South Korea
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Jeil Pharmaceutical Co., Ltd.
Anemia, Non-Dialysis-Dependent Chronic Kidney Disease
Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease
A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)
- Trial name
- NCT02648347
- Testing
- Vadadustat, Darbepoetin alfa
- Where
- 439 sites in United States, Argentina and 18 more
- Volunteers
- 1,751 people
- Sponsor
- Akebia Therapeutics
Menorrhagia
A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
This was a multicenter, open-label extension study for subjects completing either of 2 pivotal efficacy studies (NCT00401193 or NCT00386308).
- Trial name
- NCT01280981
- Testing
- Tranexamic acid
- Where
- 92 sites in United States
- Volunteers
- 288 people
- Sponsor
- Ferring Pharmaceuticals
Feeding Behavior, Late-Onset Neonatal Sepsis
Effectiveness of Oral Immunotherapy Among Preterm Babies
The aim of the study is to assess the effectiveness of OIT with colostrum on the feeding behavior and Clinical Outcome of Late-onset sepsis and Necrotizing enterocolitis
- Trial name
- NCT03633500
- Testing
- Sterile water, Breastmilk
- Where
- Kuwait
- Volunteers
- 48 people
- Sponsor
- Al Adan Hospital Kuwait
Systemic Lupus Erythematosus, Sjögren's Disease
A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases
The purpose of this study is to evaluate the safety and tolerability of BMS-986553, CD19 in vivo Chimeric Antigen Receptor (CAR) T cells, in participants with refractory autoimmune diseases including systemic lupus erythematosus…
- Conditions
- Systemic Lupus Erythematosus, Sjögren's Disease, Rheumatoid Arthritis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07873931
- Testing
- BMS-986553
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 60 people
- Sponsor
- Bristol-Myers Squibb
Anemia, Renal Insufficiency, Chronic
Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934
Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels.
- Trial name
- DIALOGUE4 (NCT01975818)
- Testing
- Molidustat (BAY 85-3934), Epoetin alfa/beta
- Where
- 35 sites in United States, Japan
- Volunteers
- 201 people
- Sponsor
- Bayer
Renal Cell Carcinoma, Melanoma
An Investigational Study of Infliximab With Prednisone or Methylprednisolone Versus Prednisone Combination Treatment in Immune Related or Severe Diarrhea in Patients Treated With Yervoy and/or Opdivo
The purpose of this study is to compare the effects of Infliximab and oral prednisone versus methylprednisolone and oral prednisone in patients with melanoma, lung cancer, or renal cell carcinoma who have immune related Grade 3-4…
- Conditions
- Renal Cell Carcinoma, Melanoma, Lung Cancer
- Trial name
- NCT02763761
- Testing
- Infliximab + Prednisone, Methylprednisolone + Prednisone
- Where
- 10 sites in United States
- Sponsor
- Bristol-Myers Squibb
Relapsed Malignant Solid Neoplasm
A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced malignancies will be done to assess AUR107 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
- Trial name
- NCT05865002
- Testing
- AUR107
- Where
- 37 sites in India
- Volunteers
- 50 people
- Sponsor
- Aurigene Discovery Technologies Limited