Clinical trials: Estrogen Receptor Negative
- Condition Estrogen Receptor Negative
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Pain
A Study of ULTRAM ER at Two Dose Levels in Adolescents With Pain
The purpose of this study is to compare the pharmacokinetic (PK) of single oral doses of ULTRAM Extended Release (ER) at 2 dose levels in adolescents between 12 and 17 years old, inclusive (up to 17 years 364 days) with pain due…
- Trial name
- NCT01586507
- Testing
- ULTRAM ER
- Volunteers
- 38 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Breast Cancer
Impact of a Food Supplement on Musculoskeletal Pain in Women With Breast Cancer Treated With Aromatase Inhibitors.
The aim of this pilot study is to assess the change in pain, measured with the Modified Brief Pain Inventory - Short Form (mBPI-sf), at 4, 8, and 12 weeks.
- Trial name
- DOLFLEX (NCT07199556)
- Testing
- Food supplement
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Arafarma Group, S.A.
Opioid-related Disorders, Opioid Addiction
ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning
Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02866266
- Testing
- Retrospective database review
- Volunteers
- 183,452 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Systemic Lupus Erythematosus
Observational Study Investigating Demographic and Clinical Characteristics of SLE Patients in Egypt
Systemic lupus erythematosus (SLE) is an autoimmune condition characterized by a complicated, unclear etiology that involves various complex factors.
- Trial name
- ROSE (NCT07144514)
- Volunteers
- 276 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer, HER2-negative Breast Cancer
Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
- Conditions
- Metastatic Breast Cancer, HER2-negative Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer
- Trial name
- TRACY-1 (NCT06590857)
- Testing
- RYZ101, Standard of Care Endocrine Therapy
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 64 people
- Sponsor
- RayzeBio, Inc.
Analgesia
Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet
A self-selection and actual use trial to evaluate the extent to which consumers will appropriately select and use the 600 mg immediate release/extended release caplets and comply with dosing instructions.
- Trial name
- NCT01789606
- Testing
- Ibuprofen 600 mg Immediate Release/Extended Release Caplet
- Where
- 18 sites in United States
- Volunteers
- 1,083 people, healthy volunteers welcome
- Sponsor
- Pfizer
Migraine
Study Designed to Evaluate the Safety of Prophylactic Depakote ER in the Treatment of Adolescents With Migraine
The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote ER is safe in the reduction of occurrence of migraine headaches in adolescents.
- Trial name
- NCT00195806
- Testing
- divalproex sodium
- Where
- United States
- Volunteers
- 315 people
- Sponsor
- Abbott
Breast Cancer
Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study
The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.
- Trial name
- NCT00255463
- Testing
- Anastrazole, Gefitinib
- Where
- 34 sites in Czechia, France and 5 more
- Volunteers
- 185 people
- Sponsor
- AstraZeneca
Social Anxiety Disorder
Study Evaluating Venlafaxine ER in Children and Adolescents With Social Anxiety Disorder
To determine the anxiolytic efficacy, safety, and tolerability of a flexible-dose of venlafaxine extended release (ER) administered for 16 weeks in the treatment of children and adolescent outpatients with social anxiety disorder…
- Trial name
- NCT00238719
- Testing
- Venlafaxine ER
- Volunteers
- 293 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Schizophrenia, Schizoaffective Disorder
A Safety and Pharmacokinetic Study of ER OROS Paliperidone in Pediatric Patients With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
The purposes of this study are to characterize the pharmacokinetics of paliperidone after single- and multiple-dose administration of paliperidone ER in children and adolescent patients (>= 10 to <= 17 years of age) with…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
- Trial name
- NCT00796081
- Testing
- ER OROS paliperidone, paliperidone ER
- Volunteers
- 25 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Pain
A Pharmacokinetic, Tolerability, and Safety Study of ULTRAM ER in Children With Pain
The purpose of this study is to compare the pharmacokinetics (PK) of single oral doses of ULTRAM Extended Release (ER) at 2 dose levels in children between 7 and 11 years old, inclusive (up to 11 years 364 days) with pain due to…
- Trial name
- NCT01586494
- Testing
- ULTRAM ER
- Volunteers
- 37 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Schizophrenia
A Double-blind, Placebo-controlled Study of the Safety and Efficacy of Paliperidone Extended Release (ER) in the Treatment of Schizophrenia in Adolescent Patients
The purpose of this study is to evaluate the efficacy, safety, and tolerability of 3 weight-based, fixed-dose groups of paliperidone extended release (ER) compared with placebo in adolescent patients between 12 to 17 years of…
- Trial name
- NCT00518323
- Testing
- Paliperidone ER
- Where
- 34 sites in United States, India and 3 more
- Volunteers
- 201 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Chronic Pain
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours.
- Trial name
- NCT00765856
- Testing
- Oxymorphone ER
- Where
- 13 sites in United States
- Volunteers
- 27 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
HIV Infections, AIDS
Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)
The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release [IR]) formulations, each in combination with lamivudine (3TC) and efavirenz…
- Trial name
- NCT00116298
- Testing
- stavudine, efavirenz, lamivudine
- Where
- 63 sites in United States, Argentina and 14 more
- Volunteers
- 900 people
- Sponsor
- Bristol-Myers Squibb
Parkinson Disease
A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period
The objective of this trial is to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR administrated orally for 12 weeks in patients with PD…
- Trial name
- NCT00560508
- Testing
- Pramipexole Immediate Release, Pramipexole Extended Release
- Where
- 19 sites in Japan
- Volunteers
- 112 people
- Sponsor
- Boehringer Ingelheim
Pain
Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain
The purpose of this study is to assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain.
- Trial name
- NCT00913627
- Testing
- ibuprofen, naproxen
- Where
- United States
- Volunteers
- 196 people
- Sponsor
- Pfizer
Opioid-related Disorders, Opioid Addiction
Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers
To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02871232
- Testing
- Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion
- Volunteers
- 26,500 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Asthma, Bronchiolitis
Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients
Phenotype characterization of shortness of breath of pediatric emergency room patients by objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy and correlates with overall patient outcomes.
- Trial name
- NCT01414322
- Where
- Israel
- Volunteers
- 45 people
- Sponsor
- KarmelSonix Ltd.
Major Depressive Disorder
Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder
The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD).
- Trial name
- NCT03569475
- Testing
- Levomilnacipran ER, Fluoxetine
- Where
- 51 sites in United States
- Volunteers
- 501 people
- Sponsor
- Allergan
Advanced Breast Cancer, Metastatic Breast Cancer
A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg
This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.
- Trial name
- FINDER I (NCT00305448)
- Testing
- Fulvestrant
- Where
- 35 sites in Japan
- Volunteers
- 143 people
- Sponsor
- AstraZeneca