Gulf Coast Research - Ongoing Studies

Gulf Coast Research, LLC specializes in managing and coordinating clinical studies for the pharmaceutical industry that involves testing of new medications and medical device entities on human volunteers. Volunteers receive office visits, study medication, and procedures at no cost to them or their insurance. Gulf Coast Research LLC usually pays volunteers for the cost of their travel to and from the research center. We work with physicians who are experts in their field of medicine to coordinate volunteers who are interested in participating in the development of new drugs and treatments. Patient volunteers can be healthy individuals or patients who are looking for a new treatment for their current illness. There are many types of studies you can participate in. If you have an interest in participating please call us at 225-757-1084 or click here Contact Us to send us an email.

Current Studies That You May Volunteer For:

Baton Rouge, LA Location
Healthy Volunteers	Healthy individuals who are willing to stay overnight at our facility for a Phase I trial. Study reimbursement of up to $2000 may be available. (Currently building database for future studies)
Schizophrenia	Adults 18-60 years of age with diagnosed schizophrenia will receive oral and IM injections for at least 52 weeks.
Type II Diabetes with moderate to severe renal Impairment or Hemodialysis	A 42 day study for adult patients age 30-75 with a historical diagnosis of type II diabetes mellitus. Patients must have moderate to severe renal impairment or must be on a stable hemodialysis treatment.
Adolescent Healthy Female Bone Density Study	Healthy adolescent females age 13 to 18 will compare the effects of (28 Day Packs) of female hormones on Bone Mineral Density. Bone loss begins in adolescents. Dexascans and other diagnostic procedures will be included at no charge.
Birth Control	Study involving a combination oral contraceptive regimen for the prevention of pregnancy in women ages 18 to 40.
Hepatitis C	Various studies available to treat people with Hepatitis C.
Gastroesophageal Reflux Disease (GERD)	Study for patients that are treated for symptoms of GERD (Gastroesophageal Reflux Disease) and continue to experience troublesome symptoms while on their current PPI (Proton Pump Inhibitor: such as Nexium).
Rheumatoid Arthritis	Upcoming study for patients with Rheumatoid arthritis who are not experiencing relief from their current treatment. Patients must be at least 18 years of age and must have previously used an Etancercept (Enbrel) or Adalimumab (Humira) as treatment for their RA.
Irritable Bowel Syndrome (IBS) with Constipation	Upcoming study using an oral medication for the treatment of IBS (Irritable Bowel Syndrome) and Constipation. Study length is up to 16 weeks.
Restless Leg Syndrome (RLS)	Study for patients 18 years or older who have experienced Restless leg syndrome (RLS) symptoms for at least 6 months.

Lafayette, LA Location
Asthma	Multiple studies for adults with asthma.
COPD (Chronic Obstructive Pulmonary Disease)	Various studies available to treat people with COPD (Chronic Obstructive Pulmonary Disease).
Gout	Study for adults 18-85 who experience frequent gout flares and are not tolerating or responding to their current medication.
HSDD (Hypoactive Sexual Desire Disorder)	A 24 week study for premenopausal or postmenopausal women with HSDD (Hypoactive sexual desire disorder)
Male HSDD (Hypoactive Sexual Desire Disorder)	Men aged 25-64 with low sexual desire and related distress will complete questionnaires during this 4 week study.

More Information

Potential Benefits to Patient volunteers:
1) Taking part in clinical studies may provide you the opportunity to participate in "cutting edge" science.
2) Participation may involve discovery of a breakthrough medical treatment for your illness.
3) Volunteers receive free, "state of the art" medical evaluations, treatment, and diagnostics during study participation - in most cases.
4) Volunteers may receive reimbursement for expenses incurred during participation in clinical studies.
5) Volunteers for Phase I Healthy Subject studies are normally paid hundreds of dollars and often over One Thousand dollars for overnight Phase I studies.

Experimental drug testing in humans:
Gulf Coast Research, LLC is a research company specializing in inpatient (Phase I) and outpatient Phase I through IV clinical trials. Our exclusive network of investigators participate in Pharmaceutical, Biological, and Medical Device product development. The clinical testing of experimental drugs is normally done in three phases, each successive phase involving a larger number of people. Once the FDA has granted a New Drug Approval (NDA), pharmaceutical companies also conduct post marketing or late phase three/phase four studies.

Phase One Studies:
Phase I testing in humans is done in a small number of healthy volunteers (20 to 80), who are usually paid for participating in the study. The study is designed to determine what happens to the drug in the human body such as how it is absorbed, metabolized, and excreted. A phase I study will investigate side effects that occur as dosage levels are increased. Ultimately pharmaceutical companies want to learn what dosages are safe in people. This initial phase of testing typically takes several months. About 70 percent of experimental drugs pass the initial phase of testing.

Phase Two Studies:
Once a drug has proven itself to be safe at different dosages and after numerous studies, it must be tested for efficacy. This second phase of testing may last from several months to two years, and involve up to several hundred patients. Safety of the drug is still a major component of Phase II testing along with efficacy. Most phase II studies are randomized trials. One group of patients will receive the experimental drug, while a second "control" group will receive a standard treatment or placebo. Often these studies are "blinded"--neither the patients nor the researchers know who is getting the experimental drug. Only an un-blinded pharmacist at the research site and the pharmaceutical company have the information identifying what the volunteer is taking. In this manner, the study can provide the pharmaceutical company and the FDA comparative information about the relative safety of the new drug, and its effectiveness. Only about one-third of experimental drugs successfully complete both Phase I and Phase II studies.

Phase Three Studies:
In a phase III study, a drug is tested in several hundred to several thousand patients at multiple sites around the country or world. This large-scale testing provides the pharmaceutical company and the FDA with a more thorough understanding of the drug's effectiveness, benefits, and the range of possible adverse reactions; safety. Most phase III studies are randomized and blinded trials such as Phase II trials as explained above.
The Phase III testing process typically last several years and involves many different studies or protocols; each of which may last only a few weeks to several months or years. There are different stages of each phase of development and Phase III studies involve different degrees of Phase III throughout the process leading up to FDA approval. i.e. Phase III and Phase IIIb studies. Seventy to 90 percent of drugs that enter Phase III studies successfully complete this phase of testing. Once a Phase III study is successfully completed, a pharmaceutical company may request FDA approval for marketing the drug.

Late Phase Three/Phase Four Studies
In late Phase III or Phase IIIb/Phase IV studies, pharmaceutical companies have several objectives: (1) studies often compare a drug with other drugs already in the market; (2) studies are often designed to monitor a drug's long-term effectiveness and impact on a patients quality of life; and (3) Many studies are designed to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies.

Should you participate in clinical research?
People participate in clinical research for a variety of reasons. People who volunteer for Phase II and Phase III trials can gain access to promising drugs long before these compounds are approved for use in the marketplace. Volunteers receive excellent care from the physicians and the Gulf Coast Research coordinators during the course of the study. This care also may be free of charge. The patient's rights and safety are protected in two important ways. First, any physician awarded a research grant by a pharmaceutical company or the NIH must obtain approval to conduct the study from an Institutional Review Board (IRB). The review board, which is usually compose of physicians and lay people, is charged with examining the study's protocol to ensure that the patient's rights are protected, and that the study does not present an undue or unnecessary risk to the patient. Second, anyone participating in a clinical trial in the United States is required to sign an "informed consent" form. This form details the nature of the study, the risks involved, and what my happen to a patient in the study. The informed consent tells patients that they have a right to leave the study at any time and receive standard care.
Patients considering participating in clinical research should talk about it with their physicians and medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study.