NCT02023047

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 17, 2015

Status Verified

January 1, 2015

Enrollment Period

1.7 years

First QC Date

December 11, 2013

Last Update Submit

November 15, 2015

Conditions

Anal Fissure

Keywords

Anal FissureNifedipine

Outcome Measures

Primary Outcomes (1)

  • To examine the effect of coated Nifedipine suppository on Anal fissure pain as measured by Visual Analog Score

    8 weeks after study initiation

Secondary Outcomes (1)

  • To investigate the Safety and tolerability of coated Nifedipine suppositories in Anal Fissure patients .

    8 weeks

Study Arms (2)

Once daily

EXPERIMENTAL

Nifedipine 12 mg Once daily

Drug: Nifedipine 12 mg coated suppositories

Twice Daily

EXPERIMENTAL

Nifedipine 12 mg twice daily

Drug: Nifedipine 12 mg coated suppositories

Interventions

Nifedipine 12 mg coated suppositoriesDRUG
Once dailyTwice Daily

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 non-lactating, 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 entry 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.

You may not qualify if:

  • 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.
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Macabi outpatient clinic

Beersheba, Negev, Israel

Location

Macabi HMO outpatient clinic

Tel Aviv, Tel Aviv, Israel

Location

Macabi outpatient clinic

Rehovot, Israel

Location

Asaf Harofe Hospital

Zrifin, Israel

Location

MeSH Terms

Conditions

Fissure in Ano

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Anus DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Nir Barak, MD

    RDD Pharma Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2013

First Posted

December 30, 2013

Study Start

March 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 17, 2015

Record last verified: 2015-01

Locations

IL(4)