Clinical trials: Oral Complication
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
Hyperphosphatemia, Chronic Kidney Disease
Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects
The primary objective is to assess the effects of colestilan on the pharmacokinetic profile of candesartan cilexetil when administered at the same time as, 1 hour before, and 3 hours after the first daily dose of colestilan…
- Trial name
- NCT01976572
- Testing
- colestilan, candesartan
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
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
Urinary Tract Infections, Cystitis
Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
Study 310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.
- Trial name
- REASSURE (NCT05584657)
- Testing
- Sulopenem etzadroxil/probenecid, Amoxicillin/clavulanate
- Where
- 167 sites in United States
- Volunteers
- 2,229 people
- Sponsor
- Iterum Therapeutics, International Limited
End-stage Renal Disease, Cardiovascular Disease
Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients
End-stage renal disease (ESRD) patients often develop cardiovascular complications, and cardiovascular disease is the leading cause of death in this population.
- Trial name
- NCT01435174
- Testing
- Ranolazine, Pharmacokinetic Blood and Dialysate Sampling, QT Interval
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of Michigan
End Stage Renal Disease
Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients
Many children with end stage renal disease develop hyperlipidemia. HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors, such as pravastatin, are typical treatments for hyperlipidemia.
- Trial name
- NCT00571194
- Testing
- pravastatin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Arkansas Children's Hospital Research Institute
Atrophy, Vaginal Diseases
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.
- Trial name
- NCT00729469
- Testing
- Ospemifene 60 mg
- Volunteers
- 919 people
- Sponsor
- Shionogi
Ovarian Neoplasm
Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer
The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.
- Trial name
- ICEBERG 2 (NCT00494442)
- Testing
- KU-0059436 (AZD2281)(PARP inhibitor)
- Where
- 11 sites in United States, Australia and 3 more
- Volunteers
- 58 people
- Sponsor
- AstraZeneca
Chronic Kidney Failure, Secondary Hyperparathyroidism
Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience
The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and secondary hyperparathyroidism.
- Trial name
- PROTECT (NCT01083186)
- Where
- 24 sites in Greece
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- AbbVie (prior sponsor, Abbott)
Candida Vulvovaginitis
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.
- Trial name
- NCT03734991
- Testing
- Ibrexafungerp
- Where
- 25 sites in United States
- Volunteers
- 376 people
- Sponsor
- Scynexis, Inc.
Pelvic Pain Associated With Refractory Endometriosis
A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis
The purpose of this study is to determine efficacy, safety, tolerability and pharmacokinetics of multiple doses of BGS649 with concurrent daily administration of combined oral contraception in patients with refractory…
- Trial name
- NCT01116440
- Testing
- BGS649
- Where
- 44 sites in United States, Puerto Rico
- Volunteers
- 27 people
- Sponsor
- Mereo BioPharma
Polycystic Ovary Syndrome
Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy
Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic state.
- Trial name
- NCT00283816
- Testing
- Metformin, Oral Contraceptive Pill, Lifestyle Management Program
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Depression, Depressive State
A Study to Compare the Pharmacokinetic Profiles of Etravil® Tablet 10mg and Etravil® Tablet 25mg
To evaluate the pharmacokinetics of single oral dose of Amitriptyline hydrochloride film-coated tablet 10mg \& 25mg
- Conditions
- Depression, Depressive State, Enuresis
- Trial name
- DWETR (NCT01367080)
- Testing
- DWETR10, DWETR25
- Where
- South Korea
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Dong Wha Pharmaceutical Co. Ltd.
Solid Tumors and Advanced Endometrial Cancer, Endometrial Cancer
A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer
This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or…
- Conditions
- Solid Tumors and Advanced Endometrial Cancer, Endometrial Cancer, Second-line Treatment, VEGF
- Trial name
- NCT01379534
- Testing
- TKI258
- Where
- 45 sites in United States, Brazil and 5 more
- Volunteers
- 53 people
- Sponsor
- Novartis Pharmaceuticals
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Tolvaptan Extension Study in Participants With ADPKD
To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.
- Trial name
- TEMPO 4/4 (NCT01214421)
- Testing
- Tolvaptan
- Where
- 97 sites in United States, Argentina and 11 more
- Volunteers
- 1,083 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Polycystic Ovary Syndrome
Continuous Versus Cyclical OCP Use in PCOS
The mainstay treatment for females with Polycystic Ovary Syndrome (PCOS) has long been a combination of an oral contraceptive pill or OCP (containing both estrogen and progestin) along with an anti-androgen medication (such as…
- Trial name
- CCOUP (NCT03819140)
- Testing
- Yasmin
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
COVID-19
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
The purpose of this study is to learn about the side effects (safety) of the study medicine PF-07321332 (nirmatrelvir)/ritonavir for the treatment of mild to moderate COVID-19 infection in adults with severe renal impairment.
- Trial name
- NCT05487040
- Testing
- PF-07321332 (nirmatrelvir)/ritonavir
- Where
- 52 sites in United States
- Volunteers
- 15 people
- Sponsor
- Pfizer
Postoperative Pain
Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy
The purpose of this study is to determine the effectiveness of an oral medication called gabapentin in reducing pain after Photorefractive Keratectomy (PRK) eye surgery and to assess the frequency of use of rescue medication…
- Trial name
- NCT00793910
- Testing
- Gabapentin
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Walter Reed Army Medical Center
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
Solid Tumor, Metastatic Bladder Cancer
Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies
The purpose of this study is to determine the maximum tolerated dose of RX-3117 in subjects with advanced or metastatic solid tumors (Phase 1).
- Trial name
- NCT02030067
- Testing
- RX-3117
- Where
- 12 sites in United States
- Volunteers
- 127 people
- Sponsor
- Processa Pharmaceuticals