Do you suffer from Hemorrhoids?

Description

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.

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