Orlando, FL (PRWEB) February 28, 2013
Avail Clinical Research is now enrolling for an Irritable Bowel Syndrome Clinical Trial in Florida. To get started, visit Avail Clinical Research or call us directly at (386) 310-1334.
Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder that is characterized by symptoms of abdominal discomfort or pain associated with altered bowel habits (Drossman, 2006). The 4 main forms of IBS are characterized by bowel habits, and are chronic or recurrent diarrhea (IBS-d), constipation (IBS-c), mixed (IBS-m), or unspecified (IBS-u). All4 fonns of IBS have in common the symptoms of abdominal pain or discomfort that may be linked to local reflexes within the bowel (Drossman, 2006). Surveys of Western populations have revealed that IBS is a common GI disorder in 15% to 20% of adolescents and adults, with a higher prevalence in women (Thompson et al, 1999). Irritable bowel syndrome is not a life threatening condition but because of a chronic relapsing course, often overlapping with other functional GI disorders, quality of life can be impaired, and high direct and indirect medical expenses and indirect costs such as absenteeism from work have been reported (Thompson et al, 1999).
Primary Objectives
To evaluate the clinical response of patients with IBS-d to a new drug, relative to placebo.
To evaluate the overall safety and tolerability of a new drug in the treatment of IBS-d.
Secondary Objectives
The secondary objective of this clinical study is to further evaluate the treatment effect of a new drug relative to placebo based on patient reports ofiBS-d symptoms (abdominal pain, abdominal discomfort, abdominal bloating, stool consistency, global symptom scores, adequate relief), bowel functioning, and quality of life.
Study Design
This Phase three, randomized, double-blind, placebo-controlled, parallel group, multicenter study was designed to evaluate the efficacy and safety of orally administered a new drug in patients with IBS-d. This phase 3 clinical study will consist of a pretreatment phase (consisting of an up to !-week prescreening period and an up to 3-week screening period), a 26-week double-blind treatment phase, and a 4-week blinded withdrawal period.
Inclusion Criteria
To be eligible for enrollment in this study, each of the following criteria must be satisfied with a “YES” answer (unless not applicable):
1. Patient is a man or woman aged 18 to 80 years, inclusive, at Prescreening.
2. Patient has a diagnosis of IBS with a subtype of diarrhea defined by the Rome III criteria as loose (mushy) or watery stools (greater than or equal to 25%) and hard or lumpy stools (less than 25% of bowel movements)
3. Patient has had a colonoscopy performed:
a. Within 10 years prior to Prescreening if patient is at least 50 years of age (alternatively, a flexible sigmoidoscopy, double contrast barium enema, or CT colonography within the past 5 years is acceptable [see recommendations of the American Cancer Society])
b. Since the onset (if applicable) of any of the following alarm features for patients of any age:
I. Patient has documented weight loss within the past 6 months;
II. Patient has nocturnal symptoms;
III. Patient has a familial history of colon cancer; or
IV. Patient has blood mixed with their stool (excluding any blood from hemorrhoids).
Note: Patients with any history of alarm features must have documentation within their medical record of the gastrointestinal work up performed.
4. Patient has an average of worst abdominal pain scores in the past 24 hours of greater than 3.0 on a 0 to 10 scale over the week prior to randomization.
5. Patient has an average stool consistency score (BSS) greater than or equal to 5.5 and at least 5 days with a BSS score greater than or equal to 5 on a 1 to 7 scale over the week prior to randomization.
6. Patient has an average daily IBS-d global symptom score greater than or equal to 2.0 on a 0 to 4 scale over the week prior to randomization.
7. Patient has completed the electronic diary on at least 6 of the 7 days during the week prior to randomization AND at least 11 of the 14 days during the 2 weeks prior to randomization. Patients have 3 weeks to meet these criteria.
8. Patient has not used any loperamide rescue medication within 14 days prior to randomization.
9. Patient is not planning to change his/her usual diet and lifestyle during the course of the study. Patients on stable doses of antidepressants (ie, for the 3 months prior to Prescreening) will be allowed to participate in the study. Medications taken tor the treatment of allergies, chronic medical conditions, and migraine headaches can be taken during this study (with the exception of opioids for acute treatment of migraines). Patient must be on a stable dose of medication for chronic migraines or preventative therapy for at least 1 month at Prescreening. As needed use of benzodiazepines for anxiety is pennitted during the study.
10. Patient is willing to be compliant with study procedures including completing a daily electronic diary (ie, IVRS) during the screening period and throughout the study.
11. Female patients must be:
a. postmenopausal, defined as as 52 years or older and amenorrheic for at least two years at prescreening;
b. surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy);
c. abstinent (for the purposes of clinical trials conducted in the United Kingdom this is defined as true abstinence when in line with the preferred and usual lifestyle of the patient in accordance with requirements of the Medicines and Healthcare products Regulatory Agency); or
d. if sexually active, be practicing an effective method of birth control such as honnonal prescription oral contraceptives, progesterone implants or injections, contraceptive patch, intrauterine device, or male partner with a vasectomy. A double-barrier method such as condoms, diaphragms, or cervical caps with spennicidal foam, cream, or gel may be used as a method of birth control. Women using oral contraceptives must also agree to nse an additional birth control method (eg, condoms). Women of childbearing potential must have a negative serum 13-human chorionic gonadotropin pregnancy test at Prescreening and a negative urine pregnancy test at Baseline before the first dose of study drug is taken.
12. Patient must sign an informed consent document before the initiation of any study-related procedures indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study.
To learn more about getting started with this paid IBS Clinical Trial, stop by Avail Clinical Research near Orlando, Florida or give us a call at (386) 310-1334.
