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Therapeutic Areas: Gastroenterology | Infections and Infectious Diseases | Family Medicine
Disease Category: Irritable Bowel Syndrome (IBS)
Location: United States, FL
Study to Evaluate the Efficacy, Safety, and Tolerability of XXXX in the Treatment Irritable Bowel Syndrome with Diarrhea
Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of XXXX in the Treatment of Patients With Diarrhea- Predominant Irritable Bowel Syndrome.
Patient Inclusion Criteria:
To be eligible for enrollment in this study, each of e following
criteria must be satisfied with a “YES” answer (unless not applicable):
- Patient is a man or woman aged 18 to 80 years, inclusive, at Pre screening.
- Patient has a diagnosis of lBS with a subtype of diarrhea defined by he Rome III criteria as loose (mushy) or watery stools I 25% and hard or lumpy stools <25% of bowel movements (by predominant stool pattern).
- Patient has had a colonoscopy performed within 5 years prior to Pre screening if they are at least 50 years of age OR if any of the following alarm features a e met:
- Patient has documented weight loss within the past 6 months;
- Patient has nocturnal symptoms;
- Patient has a familial history of colon cancer; or
- Patient has blood mixed with their stool (excluding any blood from hemorrhoids).
- 4. Patient has an average of worst abdominal pain scores in the past 24 hours of>3.0 on a 0 to 10 scale over the week prior to randomization.
- Patient has an average daily stool consistency score (BSS) of5.5 and at least 5 days with a BSS score I 5 on a 1 to 7 scale over the week prior to randomization.
- Patient has an average daily IBS-d global symptom score of72.0 on 0 to 4 scale over the week prior to randomization.
- Patient has completed the electronic diary on at least 6 of the 7 required days during the week prior to randomization AND at least 11 of the 14 required days during the 2 weeks prior to randomization. Patients have 3 weeks to meet these criteria.
- Patient has not used any loperamide rescue medication within 14 days prior to randomization.
- Patient is not planning to change his/her usual diet and lifestyle during the course of the study. Patients on stable doses of antidepressants (i.e., for the past months at Pre screening and through completion of the study) will be allowed to participate in the study. Medications taken for the treatment of allergies, chronic medic 1 conditions, and migraine headaches can be taken during this study (with the exceptio of opioids for acute treatment of migraines). Patient must be on a stable dose of med cation for chronic migraines or preventative therapy for at least 1 month at Prescreening. As needed use of benzodiazepines for anxiety is permitted during the study.
- Patient is willing to be compliant with study procedures including ompleting the daily electronic diary (i.e., rVRS) during the screening period and thr ughout the study.
- postmenopausal, defined as amenorrhea for at least 2 years at Presceening,
- surgically sterile (have had a hysterectomy or bilateral oophorectonjy, tubal ligation, or otherwise be incapable of pregnancy),
- abstinent, or
- if sexually active, be practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, c ntraceptive patch, intrauterine device, or male partner with a vasectomy. A double barrie method such as condoms, diaphragms, or cervical caps with spermicidal foam, cream, or gel may be used as a method of birth control. Women of childbearing potential must h ye a negative serum beta human chorionic gonadotropin pregnancy test at Pre screening and a negative urine pregnancy test at Baseline before the first dose of study.
- Patient must sign an informed consent document before the initiating of any study- related procedures indicating that he or she understands the purpose o and procedures required for the study and is willing to participate in the study.
Patient Exclusion Criteria:
To be eligible for this study, each of the following criteria must be satisfied with a “NO” answer:
- Patient has a diagnosis of lBS with a subtype of constipation, mixed lBS. or unsubtyped lBS by the Rome III criteria (by predominant stool pattern).
- Patient has a history of inflammatory or immune-mediated Of disorders including inflammatory bowel disease (i.e., Crohns disease, ulcerative colitis) d celiac disease.
- Patient has a history of diverticulitis within 3 months prior to Pre screening.
- Patient has a history of intestinal obstruction, stricture, toxic megac lon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic coli is, or impaired intestinal circulation (eg, aortoiliac disease).
- Patient has had a cholecystectomy or has a history of cholecystitis ithin 6 months before Prescreening.
- Patient has a history of pancreatitis of any etiology.
- Patient has a history of biliary duct disease, excluding a history of alistones.
- Patient has a history of Sphincter of Oddi dysfhnction.
- Patient has an elevated serum lipase >2 times the upper limit of no al at
- Patient has a history of maj or gastric, hepatic, pancreatic, or intes nal surgery
(excluding appendectomy, hemorrhoidectomy, or polypectomy).
- Patient has a history or current evidence of laxative abuse.
- Patient has evidence of clinically significant hepatic disease as de ned by alanine aminotransferase or aspartate amiuotransferase >3 times the upper li t of normal or total bilirubin >3 mg!dL (>51.3 mmoL/L), with the exception of Gilberts s drome, at Prescreening.
- Patient has a history of a cardiovascular event, including stroke, myocardial
infarction, congestive heart failure, or transient ischemic attack within 6 months nor to Prescreening.
- Patient has an unstable renal, hepatic, metabolic, or hematologic c ndition.
- Patient has a history of malignancy within 5 years before Prescree ing (except
squamous and basal cell carcinomas and cervical carcinoma in situ).
- Patient has a history of human immunodeficiency virus infection.
- Patient has a history of DSM-TV-TR-deflned substance dependency, excluding nicotine and caffeine, within 2 years prior to Prescreening.
- Patient has a history of alcohol abuse or binge drinking.
- Patient has uncontrolled hypertension, defined as systolic blood pr ssure >180mm Hg or a diastolic blood pressure >100mm Hg prior to randomization.
- Patient has abnormal thyroid fUnction test as confirmed by thyroid stimulating
hormone <0.05 mIU/mL or I 10 mJU/rnL at Prescreening.
- Patient has evidence of anemia as confirmed by hemoglobin <10 dL for women and <12 g/dL for men at Prescreening.
- Patient has used 5HT3 antagonists (eg, alosetron) within 14 days o Prescreening.
- Patient has used nonsteroidal anti-inflammatory drugs, when take specifically for the symptoms of IBS, within 14 days of randomization.
- Patient has current (within 14 days of randomization) or expected vse of any narcotic or opioid containing agents, docusate, enemas, GI preparations (includin4 antacids containing aluminum or magnesium, antidiarrheal agents, antinausea agents, antipasmodic agents, aspirin or aspirin containing medications [>325mg of aspirin per day], bism4th, or prokinetic agents).
- Patient has current (within 28 days of randomization) use of antibibtics (with the exception of topical antibiotics or a 1-day course with an antibiotic). Expected use f antibiotics during the course of the study that is known at the time of randomization (eg, for planned elective surgery) is also prohibited. However, a patient will be allowed to remain in the study should unplanned usc of antibiotics occur after the patient has been randomly assigned t study drug.
- Patient is unable to swallow solid, oral dosage forms whole with t e aid of liquid (patients may not chew, divide, dissolve, or crush the study drug).
- Patient has known allergies or hypersensitivity to opioids.
- Patient has received an investigational thug or used an investigati nal medical device within 30 days prior to randomization, or is currently enrolled in an investiga ional study.
- Patient has previously been dosed with XXXXX in a clinical trial.
- Patient has an elective surgery planned or expects to need elective urgery at any time during the study.
- Patient is pregnant or breastfeeding.
- Patient has any condition that, in the opinion of the investigator, uld compromise the wellbeing of the patient or the study or prevent the patient from m eting or performing study requirements.
- Patient is an employee of the investigator or study center with dire t involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Sue Lofald, Clinical Research Coordinator
3901 University Blvd, South
Jacksonville, FL 32216
Research Center Information: IMA Research
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