An Open Label Multi-Dose Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by RDD Pharma Ltd
Sponsor:
Information provided by (Responsible Party):
RDD Pharma Ltd
ClinicalTrials.gov Identifier:
NCT02023047
First received: December 11, 2013
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

This is an open label study. The study will consist of 2 treatment group: coated Nifedipine suppository containing 12 mg of Nifedipine applied twice daily (group 1) and coated Nifedipine suppository containing 12 mg of Nifedipine applied once daily (group 2). Approximately 30 subjects will participate into this 8-week study. The primary objective is to examine the dose effect of coated Nifedipine suppository on Anal fissure pain and healing.


Condition Intervention Phase
Anal Fissure
Drug: Nifedipine 12 mg coated suppositories
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Multi-Dose Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing

Resource links provided by NLM:


Further study details as provided by RDD Pharma Ltd:

Primary Outcome Measures:
  • To examine the effect of coated Nifedipine suppository on Anal fissure pain as measured by Visual Analog Score [ Time Frame: 8 weeks after study initiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the Safety and tolerability of coated Nifedipine suppositories in Anal Fissure patients . [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    safety will be assessed by the number of participants with adverse events. Tolerability will be assessed by the number of participants that discontinue treatment.


Estimated Enrollment: 30
Study Start Date: March 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Once daily
Nifedipine 12 mg Once daily
Drug: Nifedipine 12 mg coated suppositories
Experimental: Twice Daily
Nifedipine 12 mg twice daily
Drug: Nifedipine 12 mg coated suppositories

Detailed Description:

This is an open label study. The study will consist of 2 treatment group: coated Nifedipine suppository containing 12 mg of Nifedipine applied twice daily (group 1) and coated Nifedipine suppository containing 12 mg of Nifedipine applied once daily (group 2). Approximately 30 subjects will participate into this 8-week study. A screening visit will be used to determine subject suitability for inclusion in the trial. Within one week of the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will receive Coated Nifedipine 12 mg Suppository X2 a day (BID) (24 mg/day total) OR Coated Nifedipine 12 mg Suppository X1 a day (OD) (12 mg/day total) for a period of 8 weeks. During this period, 4 study visits (at 0, 2, 5, and 8 weeks) will take place. Study medication will be administered BID (in the morning and in the evening) or OD (only in the morning). In addition to receiving study medication, subjects will be maintained on a standard treatment for Anal Fissure: sitz baths, high fiber diet.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Single anal fissure
  • Signed written informed consent;
  • Male or female subjects 18 to 65 years of age;
  • Has chronic anal fissure defined as history of anal pain at least three days a week for 30 days duration or more
  • Visible fibers of the internal sphincter were seen at the base of the fissure or if a sentinel pile was present.
  • VAS of > 35 mm in screening visit
  • If female, is nonlactating, has a negative urine pregnancy test result, and does not plan on becoming pregnant during the study, or not of childbearing potential (hysterectomy or tubal ligation at least 6 months prior to entery to the study or post-menopausal for 1 year); if of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice or be willing to continue to practice appropriate birth control (such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire study duration.

Exclusion Criteria:

  • Known allergy to Nifedipine, polyethylene-glycol, propylene Glycol or silicone.
  • Fissure resulting from inflammatory bowel disease, venereal disease, perianal psoriasis, immunodeficiency syndrome.
  • Anal abscess
  • Fixed anal stenosis
  • Active or past history of cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, moderate to severe congestive heart failure, or cardiac valve abnormalities;
  • Type 1 diabetes mellitus;
  • Insulin treated type 2 diabetes mellitus;
  • History of Renal insufficiency.
  • History of Liver insufficiency.
  • Malignant disease within 5 years of screening;
  • Has uncontrolled hypertension (sitting blood pressure <160/95 mmHg at screening)
  • History of chronic gastrointestinal disease.
  • History of rectal surgery.
  • History of gastrointestinal surgery.
  • History of HIV, hepatitis B, hepatitis C.
  • In need of chronic use of medication, with the exception of birth control medications.
  • Currently uses medication for acute illness (other than medications for use of treatment/pain relief of anal fissure).
  • Has used, in the last two weeks, drugs that may affect blood coagulation, such as Aspirin at a dose higher than 500 mg/day , Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
  • Is using drug that may affect rectal tone:
  • Calcium Channel Blocker such as:

    • Nifedipine (Osmo-Adlat, Pressolat, Nifedipine -Teva, Nifedilong)
    • Amlodipine (Amlow, Norvasc, Amlodipine-Teva)
    • Lercadipine (Vasodip)
    • Verapamil (Ikacor, Ikapress, Verapress)
    • Felodipine (Penedil)
    • Diltiazem (Adizem, Dilatam)
  • Nitrate donors such as:

    • Glyceryl Trinitrate (Deponit)
    • Isosorbid dinitrate (Isoket, Isolong)
    • Isosrbid mononitrate (Monocord, Monolong, Mononit)
    • Nitroglcerine (Nitrocine, Nitroderm, Nitrolingual)
  • Has upon physical examination a rectal deformation or signs of rectal disease such as bleeding hemorrhoids, fistula. infection or space occupying lesion.
  • Is an immediate family member of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site; or
  • Is employed by RDD Pharma Ltd.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02023047

Contacts
Contact: Merav Kohelet 0508463418
Contact: Nir Barak 035114148 barak@rddpharma.com

Locations
Israel
Macabi outpatient clinic Recruiting
Beer Sheba, Negev, Israel
Contact: Shlomo Walfisch, MD       walfisch@bgu.ac.il   
Macabi outpatient clinic Recruiting
Rehovot, Israel
Contact: Natan Polokshot, MD    972577346185    natanp59@gmail.com   
Principal Investigator: Natan Polokshot, MD         
Macabi HMO outpatient clinic Recruiting
Tel Aviv, Israel
Contact: Shlomo Keizer, MD       skyzer@laniado.org.il   
Asaf Harofe Hospital Recruiting
Zrifin, Israel
Contact: Yehiel Ziv, MD    972522595876    dryziv@gmail.com   
Principal Investigator: Yehiel Ziv, MD         
Sponsors and Collaborators
RDD Pharma Ltd
Investigators
Study Director: Nir Barak, MD RDD Pharma Ltd
  More Information

No publications provided

Responsible Party: RDD Pharma Ltd
ClinicalTrials.gov Identifier: NCT02023047     History of Changes
Other Study ID Numbers: RDD 112
Study First Received: December 11, 2013
Last Updated: May 12, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by RDD Pharma Ltd:
Anal Fissure
Nifedipine

Additional relevant MeSH terms:
Anus Diseases
Fissure in Ano
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014