Do you suffer from Hemorrhoids?

  • STATUS
    Recruiting
Updated on 8 November 2020

Summary

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.

Details
Clinical Study IdentifierTX135451
Last Modified on8 November 2020

Eligibility

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note