Clinical trials: Estrogen Receptor Negative
Breast Cancer
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer
The purpose of this trial is to estimate the recommended dose (RD) of [177Lu]Lu-NeoB in combination with ribociclib and fulvestrant in participants with estrogen receptor (ER) positive (ER+), human epidermal growth factor…
- Trial name
- NCT05870579
- Testing
- [68Ga]Ga-NeoB, [177Lu]Lu-NeoB, Ribociclib
- Where
- 13 sites in United States, China and 5 more
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
Major Depressive Disorder
Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD)
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of venlafaxine ER 75 mg/day (fixed dose) and venlafaxine ER 75 mg/day to 225 mg/day (flexible…
- Trial name
- NCT01441440
- Testing
- venlafaxine ER 75 mg/day (fixed dose), venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)
- Where
- 63 sites in Japan
- Volunteers
- 538 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bipolar I Disorder
A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents
The purpose of the study is to evaluate the long-term safety profile of the Investigational Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in children and adolescents ages 10-17.
- Trial name
- NCT00195780
- Testing
- Divalproex Sodium (Depakote ER)
- Where
- 29 sites in United States
- Volunteers
- 227 people
- Sponsor
- Abbott
HR+ HER2- Breast Cancer
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants…
- Trial name
- NCT07558733
- Testing
- Serabelisib, Sapanisertib, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Faeth Therapeutics
Healthy Participants
A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants
The primary purpose of this study is to evaluate the effect of a high-fat, high-calorie meal on the relative bioavailability of NAL ER following single oral doses.
- Trial name
- NCT07487740
- Testing
- NAL ER
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Trevi Therapeutics
Chronic Pain
A Study Comparing the Effectiveness and Safety of Extended Release Tramadol Versus Placebo for the Treatment of Osteoarthritis (OA) of the Knee
The purpose of this study is to compare the analgesic effectiveness and safety of tramadol HCl ER to placebo in patients with moderate to severe pain due to osteoarthritis (OA).
- Trial name
- NCT00348010
- Testing
- Tramadol HCl ER
- Volunteers
- 245 people
- Sponsor
- Bausch Health Americas, Inc.
Healthy
Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)
The purpose of this study is to compare the subjective and objective effects of Oxymorphone ER (Opana ER) versus Oxycodone CR (Oxycontin).
- Trial name
- NCT00955110
- Testing
- Oxymorphone ER, Oxycodone CR, Hydromorphone
- Where
- Canada
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Pharmacokinetics
Drug-Drug Interaction Between Colchicine and Verapamil ER
Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp). Verapamil hydrochloride is a potent inhibitor of cytochrome P450 (CYP) 3A4 and P-gp.
- Trial name
- NCT00983242
- Testing
- Colchicine, Verapamil HCl ER
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Depressive Disorder, Major
A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder
This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse in major depressive disorder (MDD).
- Trial name
- NCT02288325
- Testing
- Levomilnacipran ER
- Where
- 47 sites in United States
- Volunteers
- 644 people
- Sponsor
- Forest Laboratories
Estrogen Receptor-positive (ER+)/Human Epidermal Growth Factor Receptor (HER2)-Negative Locally Advanced or Metastatic Breast Cancer
A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy
This is a Phase II, multicenter, open-label, randomized study to compare the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with ER+, HER2-negative, locally advanced or Metastatic…
- Trial name
- Veronica (NCT03584009)
- Testing
- Venetoclax, Fulvestrant
- Where
- 40 sites in United States, Australia and 3 more
- Volunteers
- 103 people
- Sponsor
- Hoffmann-La Roche
Schizoaffective Disorder, Psychotic Disorder
Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.
The purpose of this study is to measure the effectiveness and assess the safety of two dosages of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder.
- Trial name
- NCT00397033
- Testing
- Paliperidone ER
- Volunteers
- 316 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Influenza
Study on the Burden of Influenza-related Hospitalizations and Emergency Room (ER) Visits in Children in Spain
This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed influenza, and compare the clinical features, severity, complications, risk factors and socioeconomic impact of influenza in children…
- Trial name
- NCT01592799
- Testing
- Throat swab and/or nasopharyngeal swab, Data collection
- Where
- Spain
- Volunteers
- 501 people
- Sponsor
- GlaxoSmithKline
Breast Cancer
Study of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer
This clinical trial is evaluating a drug called AC699 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer.
- Trial name
- NCT05654532
- Testing
- AC699
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Accutar Biotechnology Inc
Overactive Bladder
Web-based Methodology Trial to Evaluate the Efficacy and Safety of Tolterodine ER in Subjects With Overactive Bladder
To compare the effect of tolterodine ER 4 mg to placebo on patient reported outcomes in subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative web-based trial design
- Trial name
- REMOTE (NCT01302938)
- Testing
- Tolterodine ER
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Advanced ER+/HER2- Breast Cancer
Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients
This study is a multi-center, open label, phase Ib/II clinical trial aimed at evaluating the safety, preliminary efficacy characteristic and PK characteristics of QLS1304 in combined with endocrine therapy in ER+/HER2- breast…
- Trial name
- NCT07235176
- Testing
- QLS1304 tablet+Fulvestrant or QLC1401, QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Cerebral Palsy (CP)
Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to evaluate the safety and tolerability and the effect of dalfampridine extended release (ER) tablets on sensorimotor function
- Trial name
- NCT01468350
- Testing
- dalfampridine-ER 10mg
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Acorda Therapeutics
Schizophrenia
Evaluation of Effectiveness and Safety of Paliperidone ER (Extended-release) Compared With Quetiapine in Patients With Schizophrenia
The purpose of this study is to evaluate the efficacy (effectiveness of drug) and safety of the antipsychotic paliperidone ER compared to another antipsychotic, quetiapine, and to placebo in patients who are acutely ill with…
- Trial name
- NCT00334126
- Volunteers
- 399 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Metastatic Breast Cancer
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and…
- Trial name
- ELAINEIII (NCT05696626)
- Testing
- Lasofoxifene in combination with abemaciclib, Fulvestrant in combination with abemaciclib
- Where
- 224 sites in United States, Australia and 15 more
- Volunteers
- 600 people
- Sponsor
- LeonaBio
Depression, Depressive Disorder
Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of TNX-601 ER monotherapy versus placebo in patients with Major Depressive Disorder (MDD).
- Conditions
- Depression, Depressive Disorder, Depressive Symptoms, Depressive Disorder, Major
- Trial name
- UPLIFT (NCT05686408)
- Testing
- TNX-601 ER
- Where
- 27 sites in United States
- Volunteers
- 132 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
Breast Cancer
Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.
- Trial name
- ELONA (NCT05618613)
- Testing
- Elacestrant, Onapristone
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Context Therapeutics Inc.