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DISCLAIMER: This site contains information about clinical trials conducted by Aspen Clinical Research and affiliate companies. This information is not intended to replace the advice of your health care professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, please consult a physician. Aspen Clinical Research is committed to meeting patient needs through innovative medicine and clinical excellence. As part of the development process for medicines, Aspen Clinical Research conducts research to help determine safety and efficacy of various test medications; and conducts research with the intent of learning more about treatment options, disease states, diagnostics, and other associated issues that contribute to the health and well being of study subjects. Clinical research often occurs in the form of clinical trials and observational / non-interventional studies. This information may, or may not, relate to uses that have been studied and approved by various regulatory agencies around the world. The information contained in this site is not intended to promote or otherwise commercialize (directly or indirectly) any off-label or unapproved uses of study related medicines.<br> There are many factors beyond individual trial/study results that must be considered in order to determine whether a drug is safe, effective, or appropriate for a particular use. When making prescribing decisions, physicians should always refer to the specific labeling information approved for the patientŐs country or region. Clinical trials and observational / non-interventional studies on pharmaceutical products may also be sponsored and reported by parties in other clinical trial registries. The company's policy of public data disclosure is provided for your information. Select any of the following links to get information related to clinical trials and/or observational / non-interventional studies affiliated with Aspen Clinical Research: Clinical Trial Results by Therapeutic Area: Provides summaries of completed clinical trials and/or references to publications for marketed products by therapeutic area. These include Allergies, Alzheimer's disease (AD), Anxiety (GAD), Bipolar disorder, Bunionectomy, Depression, Diabetes, Diabetic Neuropathy (DPN), Colorectal Cancer, Cancer break through pain, Chronic low back pain, Hair loss, Healthy Male and Female studies, High blood pressure, High cholesterol, HIV, HIV neuropathy, Irritable bowel syndrome, Obesity, Osteoarthritis, Post-herpetic neuralgia, Recreational drug abuse, Insomnia, Wisdom tooth extraction<br> Clinical Trial Conduct: All studies conducted by Aspen Clinical Research are in full compliance with all regulatory agencies within the U.S. and international guidelines including: Food and Drug Administration (FDA), International Committee on Harmonization (ICH), Good Clinical Practices (GCP), Canadian Drug Directorate (CCD), Committee on Safety of Medicines (CSM), Center for Study of Drug Development (CSDD), Cooperative Research and Development Agency (CRADA), Center for Medical Devices and Radiologic Health (CMDRH), Center of Food Safety and Applied Nutrition (CFSAN), and the Code of Federal Regulations (CFR) Terminology: Commonly used terms in drug discovery and development include; (AAPS) American Association of Pharmaceutical Scientists, (ABPI) Association of British Pharmaceutical Industries, (ACE) Adverse Clinical Event, (ACRP) Association of Clinical Research Professionals, (ADAS) Alzheimer's Disease Assessment Scale, (ADME) Absorption, Distribution, Metabolism, and Excretion, (AED) Antiepileptic Drugs, (ANDA) Abbreviated New Drug Application, (ARDS) Adult Respiratory Distress Syndrome, (BIND) Biological IND, (BIOLOGIC) Blood Products, Vaccines and Cellular Therapy Products, (BMI) Body Mass Index, (BMR) Basil metabolic rate, (BP) Blood pressure, (BPAD) Bipolar Affective Disorder, (BPM) Beats Per Minute, (BSA) Body Surface Area, (BUN) Blood Urea Nitrogen, (CAD) Coronary Artery Disease, (CCRA) Certified Clinical Research Associate, (CCRC) Certified Clinical Research Coordinator, (CDC) Center for Disease Control, (CDER) Center for Drug Evaluation and Research (FDA), (CFR) Code of Federal Regulations (FDA), (CRA) Clinical Research Associate, (CNS) Central Nervous System, (COSTART) Coding Symbols for Thesaurus of Adverse Reaction Terms (FDA, (CRC) Clinical Research Coordinator, (CRO) Contract Research Organization, (CT) Clinical Trial, (CV) Curriculum Vitae, (DB) Double-Blind, (DCF) Data Correction Form/Data Clarification Form, (DESI) Drug Efficacy Study Implementation, (DJD) Drug Efficacy Study Implementation, (EIR) Establishment Inspection Report, (FDA 482) Notice of Inspection, (FDA 483) Notice of Adverse Findings in an Inspection, (FDA 1572) FDA Form for Statement of Investigator, (GCP) Good Clinical Practice, (HAZCOM/HAZMAT) Hazardous Communication/Hazardous Materials, (IB) Investigator's Brochure, (ICH) International Committee on Harmonization, (IDB) Investigational Drug Brochure, (IDE) Investigational Device Exemption, (INDA) Investigational New Drug Application, (IPCS) Investigational New Drug Committee, (IRB) Independent Review Board, (JCRDD) Journal of Clinical Research and Drug Development, (JCRP) Journal of Clinical Research and Pharmacoepidemiology, (MDD) Manic Depressive Disorder, (MDR) Medical Device Reporting, (MTD) Maximum Tolerated Dose, (NCVIA) Nerve Conduction Velocities, (OPRH) Office of Protection for Research in Humans, (OSHA) Occupational Safety and Health Administration, (PAR) Post-Approval Research, (PI) Package Insert, (PD) Pharmacodynamics, (PK) Pharmacokinetics, (QA) Quality Assurance, (QC) Quality Control, (R&D) Research and Development, (RDC) Remote Data Capture, (SAE) Serious Adverse Event, (SMO) Site Management Organization, (WHO) World Health Organization. Professional Affiliations: We are affiliate members of the Drug Information Association (DIA), Association of Clinical Research Professionals (ACRP), Society of Clinical Research Associates (SoCRA), American Pain Society (APS), American Psychiatric Association (APA), Children & Adults with Attention Deficit/Hyperactivity Disorder (CHADD) Clinical Phases of Study: Phase I, Phase IIa (Phase 1 (one), Phase 2a (two A)) Safety/Tolerability Studies QT and QTc Evaluations Full PK/PD characterizations in plasma, urine, & Cerebrospinal Fluid (CSF) Single Ascending Dose (SAD) Multiple Ascending Dose (MAD) Maximum Tolerated Dose (MTD) Phase IIb, Phase III, Phase IV (Phase 2b (two B), Phase 3 (three), Phase 4 (four)) Study feasibility and protocol development Multi Center Recruitment Inpatient/Outpatient Trials Proof of Concept Studies Studies to Support Label Claims Safety and Efficacy Studies Hospital and University Collaborations for Patient Population Recruitment
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