NCT00972907

Brief Summary

This is an open label study. The study will consist of 1 treatment group: coated Nifedipine suppository containing 12 mg of Nifedipine, administered BID to subjects with chronic anal fissure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

2 active sites

Status
completed

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

September 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 16, 2011

Status Verified

February 1, 2011

Enrollment Period

1.1 years

First QC Date

September 8, 2009

Last Update Submit

February 15, 2011

Conditions

Chronic Anal Fissure

Keywords

anal fissurepainnifedipine

Outcome Measures

Primary Outcomes (2)

  • To examine the effect of coated Nifedipine suppository on Anal fissure pain.

    8 weeks

  • To examine the effect of coated Nifedipine suppository on Anal fissure healing.

    8 weeks

Secondary Outcomes (1)

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

    8 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Nifedipine coated suppositories BID.

Drug: Nifedipine coated suppositories

Interventions

Nifedipine coated suppositoriesDRUG

12 mg Nifedipine coated suppositories BID

Treatment

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 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 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
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sapir Medical Center

Kfar Saba, Israel

Location

Macabi HMO

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Fissure in AnoPain

Condition Hierarchy (Ancestors)

Anus DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 9, 2009

Study Start

December 1, 2009

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

February 16, 2011

Record last verified: 2011-02

Locations

IL(2)