Studies

Kodiac

This is a clinical research study looking at whether an investigational medication is safe and effective in treating constipation commonly occurring in people taking opioid pain medications like morphine. Study participation lasts approximately 18 weeks (4.5 months) and there are 9 office visits.

  • Males and females 18 to 84 years old
  • Taking at least one opioid pain medication daily
  • Experiencing constipation symptoms such as:
    • Fewer than three bowel movements per week
    • Hard/lumpy stools
    • Straining
    • Sensation of incomplete bowel movements
  • Participants cannot be pregnant or breastfeeding.
  • Participants cannot be taking opioid pain medication for pain related to cancer.

Diabetes and Hypertension

This 19 week study (10 office visits) is to evaluate the effects of a new medication for those with Hypertension and Diabetes. Patients will be required to monitor but not record blood glucose with provided meter once a day before breakfast and to wear a 24hr Blood Pressure Recording device two times during the study.

  • Between 18-89 years of age
  • Have Systolic blood pressure between 140-165mmHg and Diastolic blood pressure between 85 and 105mmHg
  • Currently taking at least 1 Oral Anti-diabetic
  • Currently taking an ACEI (Angiotensin Converting Enzyme inhibitors) or ARB (Angiotensin Receptor Blocker
  • Currently taking 1 additional antihypertensive

Mild to Moderate Alzheimer's Disease

A new study is enrolling for patients suffering from Mild to Moderate Alzheimer's Disease.

  • Ability to provide written informed consent by the patient
  • 50-80 years of age
  • Inability to tolerate MRI procedures or contraindication to MRI, including but not limited to pacemakers; implantable cardioverter defibrillators; cochlear implants; cerebral aneurysm clips, etc.
  • Female patient with reproductive potential

Sickle Cell Disease

The primary objective of this study is to assess the safety of prasurgel compared to placebo in adults patients with sickle-cell disease as measured by the incidence of hemorrhagic events requiring medical intervention through 30 days of treatment.

  • Sickle Cell Disease
  • No VOC with-in the past 30 days
  • 18 years of age or older

Menopause

A phase 3, twenty four week, double blind study in the treatment of Vasomotor symptoms associated with menopause. This is a 24 week study, which will require competition of 6 office visits and 8 telephone calls.

  • Female
  • 40 years old or over
  • Experiencing or have experienced Menopause
  • Currently experiencing hot flashes
  • Currently not taking hormones
  • Not taken medications for an psychiatric disorders or been under the care of a psychiatric professional
  • Not currently participating in any other research study
  • Planning to be in the area for the next 6 months

Sexual Desire in Post-Menopausal Women (1)

This study is testing the safety and efficacy of a testosterone gel applied daily in the improvement of sexual desire in post-menopausal women. Post-menopausal is defined as either natural menopause for 12 months or after a full hysterectomy with both ovaries removed prior to natural menopause. We are looking for women over 50 years old to participate in this 5 year study. There are 9 clinic visits and 14 phone calls. Please note that 5 of the 9 clinic visits are within the first year of participation, however, the remaining 4 clinic visits take place once a year until the fifth year of participation.

  • Are between 60 and 70 years old, or are age 70 and older
  • Are presently smoking half a pack a day
  • Have high blood pressure
  • Have high cholesterol
  • Have a history of cardiovascular disease more than 6 months ago (i.e. heart attack, stroke, etc)
  • Interest in increasing their sexual desire
  • The use of systemic anti-androgens, tamoxifen, or other selective estrogen receptor modulators
  • A history of breast, endometrial, or gynecological cancer, or any melanoma
  • Have Diabetes mellitus
  • A history of major psychiatric illness, a history of cancer of any other kind in the last 10 years
  • A history of cardiovascular history less than 6 months ago (i.e. heart attack, stroke, etc)
  • Any bleeding disorders requiring regular transfusions
  • Any history of scleroderma
  • The known presence of breast cancer genes (BRCA1 or BRCA2)

Sexual Desire in Post-Menopausal Women (2)

Treatment of low sexual desire in surgically post-menopausal (i.e. hysterectomy prior to natural menopause). This is an 8 week pretreatment period and 6 month treatment period (9 visits). There will be a 50:50 chance of receiving the active ingredient which is a testosterone gel. Patients are required to complete a daily journal and apply a gel to upper arm daily.

  • 30-65 years old
  • Have had a Hysterectomy with both ovaries removed prior to natural menopause
  • Able to receive a stable dose of estrogen therapy for 2 months
  • In a stable monogamous relationship for 1 year
  • Has uncontrolled diabetes or thyroid disease
  • Is currently taking antidepressants
  • Generally healthy
  • Wants to increase sexual desire
  • Severe acne
  • Has untreated high blood pressure
  • Has another diagnosed sexual dysfunction
  • Has a history of breast, endometrial, or gynecological cancer, melanoma

Diabetes Mellitus

This is a 26 week study (+2 weeks of screening) with 7 clinic visits (+3 dietary visits if randomized into the dietary arm) and 21 weekly phone visits. This trial is for people with Type II Diabetes Mellitus who are currently on Metformin and any other Oral Anti-diabetic (OAD) medications.

  • Male or female ≥ 18 years of age at screening
  • Type 2 diabetes (diagnosed clinically) for ≥ 6 months prior to screening
  • Cardiovascular disease, within the last 6 months prior to Visit 1
  • Uncontrolled treated/untreated severe hypertension
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months)
  • Known proliferative retinopathy or maculopathy requiring treatment

Irritable Bowel Syndrome with Diarrhea

This is a study of an investigational medication being evaluated to see if it is safe, tolerable, and can help people with Irritable Bowel Syndrome with Diarrhea. Study participation is approximately 4 months with 8 clinic visits. Participants will be asked to complete daily telephone diaries for the duration of the study.

  • Males and females aged 18 to 65 years
  • Diagnosis of IBS with a subtype of diarrhea
  • Participant is not planning to change his/her usual diet and lifestyle during the course of the study
  • Participant is willing to complete a daily electronic diary during the screening period and throughout the study
  • Participant is willing to use an effective method of birth control during the study
  • Participants cannot have gastrointestinal disorders other than Irritable Bowel Syndrome
  • Participants cannot have had bowel surgeries
  • Participants cannot be pregnant or breastfeeding

Iron Deficiency Anemia

This is a study of an investigational medication being evaluated to see if it is safe, tolerable and can help people with Iron Deficiency Anemia (patients with low iron levels) who cannot take oral iron (iron pills). This medication will be administered through an IV Infusion. Study participation lasts approximately 7 weeks with 7 clinic visits.

  • Males and females 18 years or older
  • Diagnosis of Iron Deficiency Anemia
  • History of unsatisfactory oral iron therapy or in whom oral iron cannot be used
  • Participants must be using an effective method of birth control
  • Participants cannot be pregnant, intend to become pregnant, breastfeeding or have given birth within the past 2 weeks
  • Participants cannot have any known causes of anemia other than iron deficiency
  • Participants cannot have had major surgery within the past 4 weeks, or any planned surgery during the course of the study