New Irritable Bowel Syndrome (IBS) Clinical Trial Now Enrolling at Avail Clinical Research Near Orlando, Florida; Accepting Healthy Female Participants Age 18-65
Orlando, Florida (PRWEB) July 30, 2013 -- *To see if you qualify for this IBS Clinical Trial in Florida, visit Avail Clinical Research on the web (http://www.availclinical.com) or contact us directly at (386) 785-2404. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.
STUDY DESIGN AND DURATION
This irritable bowel syndrome clinical trial will be conducted as a multicenter, double-blind, randomized, placebo-controlled efficacy and safety study in adult female subjects with IBS-D. The 3-period study design consists of a screening period of up to 30 days, a 4-week treatment period, and a 4-week follow-up period. The duration of estimated subject-participation time for the study is 12 weeks.
BACKGROUND & RATIONALE
Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder characterized by abdominal pain or discomfort and altered bowel habits without identifiable organic disease to explain the symptoms. The prevalence of IBS in North America is approximately 10 to 15% of the adult population with an approximately 2-fold higher incidence for women. Although it is not life threatening, the symptoms of IBS are among the most common reasons for visits to primary care physicians and gastroenterologists due to the serious impact on the patient’s quality of life.
Patients are classified into the following 4 subtypes by the stool pattern using the Bristol Stool Scale (BSS); IBS with diarrhea (IBS-D), IBS with constipation (IBS-C), mixed IBS (IBS-M) and unsubtyped IBS. The predominance of each subtype varies in reports from equal distribution of IBS-D, IBS-C and IBS-M to higher IBS-D or IBS-M type occurrence. A significant unmet need in the management of IBS is discovery of a safe and effective treatment that relieves pain, reduces bowel motility dysfunction, and improves global symptoms.
PRIMARY OBJECTIVES
The primary objective of the study is to explore efficacy of a new IBS drug in abdominal pain or stool symptoms (ie, number and consistency of stool) in female subjects with IBS-D.
SECONDARY OBJECTIVES
The secondary objectives of the study include:
To explore efficacy of this new drug in stool urgency, abdominal discomfort, adequate
To investigate the safety and tolerability of this new drug in female subjects with IBS-D
To assess the PK of this new drug in female subjects with IBS-D relief of IBS symptoms or IBS-related pain and QoL in female subjects with IBS-D
INCLUSION CRITERIA
1. Female, age 18 to 65 years old inclusive at the time of signing the ICF;
2. Ambulatory outpatient, not requiring nursing care or wheelchair;
3. Meet criterion for either a) and c) or b) and c):
a) Surgically sterilized (eg, hysterectomy or bilateral oophorectomy) for at least 6 months or postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year prior to Visit 1 and have a plasma FSH level of >40 IU/L at Visit 1); or
b) Females of childbearing potential who are non-lactating and agree to use a double barrier method of contraception (eg, intrauterine device plus condom, spermicidal gel plus condom) from 21 days prior to dosing until 28 days after dosing, and
c) Negative β-hCG test for pregnancy at both Visit 1 and Visit 3;
4. Diagnosed with IBS based on the following Rome III criteria:
a) Symptom onset at least 6 months prior to diagnosis, and
b) Having recurrent abdominal pain or discomfort at least 3 days per month for the past 3 months, and
c) Abdominal discomfort or pain associated with two or more of the following at least 25% of the time:
i) Improvement with defecation
ii) Onset associated with a change in frequency of stool/defecation
iii) Onset associated with a change in form (appearance) of stool
5. Diagnosed with IBS-D defined as loose/watery stools ≥ 25% and hard/lumpy stools < 25% of defecations;
6. Underwent a flexible sigmoidoscopy or a colonoscopy with a normal result based on clinical findings after the onset and/or any significant worsening of IBS symptoms within the last 5 years of Visit 1;
7. Must have documented an average daily score greater than or equal to 3.0 (on a 0-10 point numeric rating scale [NRS]) for IBS-related worst abdominal pain during the 2-week baseline window (Day -14 to Day -1);
8. Must have documented at least 2 days each week with at least one stool which has a consistency of Type 6 or 7 and less than 2 days each week with at least one stool which has a consistency of Type 1 or 2 on the BSS during the 2-week baseline window (Day -14 to Day -1);
9. Must have conducted self-assessments of IBS symptoms in the subject diary for at least 5 days each week during the 2-week baseline window (Day -14 to Day -1);
10. Able and willing to provide signed, written, informed consent
- Avail Clinical Research conducts Phase I Clinical Trials in Florida. For more information about participating in an IBS Clinical Study, please visit our website or contact us directly at (386) 785-2404.
Jennifer Economou, Avail Clinical, http://www.availclinical.com, (386) 785-2400 x336, [email protected]
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