Clinical trials: Estrogen Receptor Negative
- Condition Estrogen Receptor Negative
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Pain, Post-Operative Pain
Ibuprofen Extended-Release Dental Pain Study
The purpose of this study is to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth.
- Conditions
- Pain, Post-Operative Pain, Third Molar Extraction
- Trial name
- NCT00707057
- Testing
- Ibuprofen 600 mg Extended-Release Tablets
- Where
- United States
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- SCOLR Pharma, Inc.
Attention Deficit Hyperactivity Disorder, ADHD
Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention…
- Trial name
- NCT01239030
- Testing
- Methylphenidate Hydrochloride Extended Release Capsules
- Where
- 16 sites in United States
- Volunteers
- 230 people
- Sponsor
- Rhodes Pharmaceuticals, L.P.
Dental Pain
Study of Long-Acting Acetaminophen in Postoperative Dental Pain
The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the…
- Trial name
- NCT01960114
- Testing
- Acetaminophen ER
- Where
- United States
- Volunteers
- 403 people
- Sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
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
Hypercholesterolemia, Familial, Heterozygous Familial Hypercholesterolemia
A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)
The purpose of this study is to determine the pharmacokinetics of laropiprant following administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of MK-0524A in adolescents with heterozygous familial…
- Trial name
- NCT01583647
- Testing
- MK-0524A
- Volunteers
- 10 people
- Sponsor
- Merck Sharp & Dohme LLC
Opioid-related Disorders, Opioid Addiction
ER/LA Opioid Analgesics - Surveillance Monitoring of State Medical Examiner Databases
In April 2011, the U.S. Food and Drug Administration (FDA) determined that a class-wide risk evaluation and mitigation strategy (REMS) for all extended-release (ER) and long-acting (LA) opioid medications was necessary to support…
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02897414
- Testing
- Surveillance of state medical examiner databases
- Volunteers
- 13,015 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
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
Breast Cancer
DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)
A randomized, Phase II trial of circulating tumor DNA-guided second line Adjuvant therapy for high Residual risk, Estrogen Receptor positive, HER-2 negative breast cancer (DARE)
- Trial name
- DARE (NCT04567420)
- Testing
- Palbociclib, Fulvestrant, Adjuvant Therapy
- Where
- 19 sites in United States
- Volunteers
- 70 people
- Sponsor
- Criterium, Inc.
Migraines
A Phase III Open-Label, Multi-Center, Long-Term Extension Study of Depakote ER in Subjects Who Either Completed or Prematurely Discontinued Due to Ineffectiveness From Study M02-488.
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
- NCT00195754
- Testing
- divalproex sodium
- Where
- United States
- Volunteers
- 114 people
- Sponsor
- Abbott
Breast Cancer
Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients
This multicenter, prospectively designed study examines whether the Prosigna score influences physician and patient adjuvant treatment selection over and above currently used prognostic factors.
- Trial name
- NCT02625935
- Where
- 4 sites in United States
- Volunteers
- 206 people
- Sponsor
- NanoString Technologies, 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
Advanced Solid Tumor, Advanced Malignant Neoplasm
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C…
- Conditions
- Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor
- Trial name
- NCT04585750
- Testing
- rezatapopt, pembrolizumab
- Where
- 76 sites in United States, Australia and 7 more
- Volunteers
- 300 people
- Sponsor
- PMV Pharmaceuticals, Inc
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)
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
Migraine
The Safety and Efficacy of Divalproex Sodium Extended-Release Tablets in Migraine Prophylaxis: A Study in Adolescents
The purpose of this study is to determine whether Depakote ER is safe and effective in the reduction of occurrence of migraine headaches in adolescents.
- Trial name
- NCT00195741
- Testing
- divalproex sodium
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Abbott
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
A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna Gene Signature Assay
The primary objective of this study is to assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and…
- Trial name
- NCT01899079
- Where
- 7 sites in Spain
- Volunteers
- 217 people
- Sponsor
- NanoString Technologies, Inc.
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.
Epilepsy
Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release…
- Trial name
- NCT00175903
- Testing
- Levetiracetam, Carbamazepine Controlled Release (CBZ-CR), Valproate Extended Release
- Where
- 229 sites in Australia, Austria and 22 more
- Volunteers
- 1,701 people
- Sponsor
- UCB Pharma
ER/PR(+), Her2(-) Breast Cancer
Clinical Outcome Of Hormonal Receptor Positive, Her-2 Negative Breast Cancer In Taiwan
Breast cancer is the most common cancer in Taiwanese women. Most of them were diagnosed in relatively early stages. Only 700 metastatic breast cancer were registered in Official Cancer Registration 2012, while more than11,305…
- Trial name
- NCT02924584
- Where
- Taiwan
- Volunteers
- 1 people
- Sponsor
- Pfizer