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Therapeutic Areas: Gastroenterology | Family Medicine
Disease Category: Hemorrhoids
Location: United States, FL
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Efficacy and Safety Study to Treat Subjects With Symptomatic Internal Hemorrhoids
Inclusion Criteria for Double-Blind and Recurrence
- Males or non-pregnant females, aged ≥ 18 to ≤ 75 years.
- Symptomatic internal hemorrhoids, Grades I-III by direct anoscopic visualization (anoscopic visualization not required if Grade determined by colonoscopy within 28 days prior to Day 1).
- Bleeding from hemorrhoids for two consecutive days prior to randomization (Day 1).
- For females experiencing menses, on the two days prior to randomization they must confirm that blood is from the anus and not from their menses by gently inserting a cotton swab into the anus after attempting a bowel movement; and they must see blood on the cotton swab for the two consecutive days prior to randomization to meet the inclusion criteria.
- Itching OR pain for two consecutive days prior to randomization (Day 1).
- Able to attempt bowel movements daily (defined as trying to have a bowel movement while sitting on the toilet for at least a few minutes, at least once daily, whether or not you feel the need to have a bowel movement that day).
- Body mass index of ≥ 18.5 to ≤ 36 kg/m2.
- Female of non-childbearing potential, including any female who: a) has had a hysterectomy, b) has had a bilateral oophorectomy, c) has had a bilateral tubal ligation or d) is post menopausal (demonstration of total cessation of menses for ≥ 1 year from the date of the screening visit).
- Females of child bearing potential who agree to use two forms of contraception, one of which must be a barrier method, during the full duration of the study.
- Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
- Capable of using the IVRS and adequately communicate comprehension of IVRS questions to the investigator.
- Capable of and freely willing to provide written informed consent prior to participating in the study.
Exclusion Criteria for Double-Blind and Recurrence
- Grade IV internal hemorrhoids.
Age ≥ 40 years, with no complete colon evaluation within one year.
- Age < 40 years, with no sigmoidoscopy or complete colon evaluation within one year.
- Age < 40 years, with any of the following and no complete colon evaluation within one year:
- History of adenomatous polyps.
- Family history of either colorectal cancer or colorectal adenomas diagnosed in a first-degree relative before age 60.
- Family history or genetic testing indicating the presence of one of two hereditary syndromes.
- Malignancy within 5 years prior to Day 1(with the exception of treated basal cell/squamous cell carcinoma of the skin).
- History of inflammatory bowel disease.
- History of irritable bowel syndrome with constipation or diarrhea.
- Previous surgical or instrumental treatment of internal hemorrhoids.
- Clinical evidence or history of fecal incontinence.
- Current thrombosed internal or external hemorrhoid(s).
- Clinical evidence or history of anal fissure.
- Clinical evidence or history of anal fistula.
- AST/ALT > 3x ULN.
- Hemoglobin < 10.0 g/dL.
- Selective serotonin reuptake inhibitors within 28 days prior to Day 1.
- Tamoxifen within 28 days prior to Day 1.
- Laxatives (unless maintained on a stable dose of the medication for ≥ 60 days prior to Day 1).
- Anticoagulants (e.g., coumadin, heparinoids, dabigatran) within 90 days prior to Day 1.
- Anti-platelet agents or low dose aspirin (unless maintained on the medication for ≥ 90 days prior to Day 1).
- Over the counter or prescription anti-hemorrhoid agents (including herbal supplements) within 14 days prior to Day 1.
- Topical anesthetics within 14 days prior to Day 1.
- Chronic use of analgesics (e.g., opioids, acetaminophen, aspirin, NSAIDS, cox-2 inhibitors, etc).
- Any investigational agents within 28 days prior to Day 1 (with the exception of iferanserin for recurrence).
- Anti-TNF agents within 6 months prior to Day 1.
- Oral or parenteral steroids within 28 days prior to Day 1.
- Use of anal, intra-anal, or intra-rectal steroids within 28 days prior to Day 1.
- Expected to have a planned interventional and/or surgical procedure that requires hospitalization, colonoscopy, or sigmoidoscopy (colonoscopy or sigmoidoscopy during the screening period is acceptable).
- Following concomitant disease state:
- Clinical evidence or history of significant cardiovascular disease including arrhythmias, clinically significant ECG abnormalities, myocardial infarction, stroke, congestive heart failure (greater than class II), and valve disease or abnormalities.
- Asthma currently requiring treatment (with the exception of infrequent use of rescue inhaler).
- Clinical evidence or history of chronic renal failure (greater than Stage III).
- Clinical evidence or history of gastric ulcer, duodenal ulcer, or pancreatitis.
- Clinical evidence or history of hematological disease.
- Clinical evidence or history of neurological disease.
- Acute infection currently requiring treatment.
- Clinical evidence or history of chronic infectious disease.
- Major organ transplant.
- Any disease or prior surgery that may interfere with the subject successfully completing the study.
- History of any prior anal or rectal surgery (including hemorrhoid banding).
- Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (with the exception of intermittent anxiety).
- Known sensitivity to investigational product(s) or class of investigational product(s).
- Drug or alcohol abuse within 12 months of Day 1.
- Currently using narcotic(s) chronically.
- Breast-feeding females.
- Females on their menstrual cycle who cannot discern whether the bleeding is rectal bleeding or vaginal bleeding from menstruation.
- Employees, family members, or students of the investigator or clinical site.
Raquel Gonzalez, CRC
760 East 49th Street
Hialeah, FL 33013
Research Center Information: Eastern Research
If you would like to learn more about participating in this study, please send an email message using the form below.
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