An Open Label Multi-Dose Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing
Primary Purpose
Anal Fissure
Status
Terminated
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Nifedipine 12 mg coated suppositories
Sponsored by
About this trial
This is an interventional treatment trial for Anal Fissure focused on measuring Anal Fissure, Nifedipine
Eligibility 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 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.
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)
- Nitroglycerine (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.
Sites / Locations
- Macabi outpatient clinic
- Macabi outpatient clinic
- Macabi HMO outpatient clinic
- Asaf Harofe Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Once daily
Twice Daily
Arm Description
Nifedipine 12 mg Once daily
Nifedipine 12 mg twice daily
Outcomes
Primary Outcome Measures
To examine the effect of coated Nifedipine suppository on Anal fissure pain as measured by Visual Analog Score
Secondary Outcome Measures
To investigate the Safety and tolerability of coated Nifedipine suppositories in Anal Fissure patients .
safety will be assessed by the number of participants with adverse events. Tolerability will be assessed by the number of participants that discontinue treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02023047
Brief Title
An Open Label Multi-Dose Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing
Official Title
An Open Label Multi-Dose Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
Met primary endpoint
Study Start Date
March 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RDD Pharma Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fissure
Keywords
Anal Fissure, Nifedipine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Once daily
Arm Type
Experimental
Arm Description
Nifedipine 12 mg Once daily
Arm Title
Twice Daily
Arm Type
Experimental
Arm Description
Nifedipine 12 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Nifedipine 12 mg coated suppositories
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To investigate the Safety and tolerability of coated Nifedipine suppositories in Anal Fissure patients .
Description
safety will be assessed by the number of participants with adverse events. Tolerability will be assessed by the number of participants that discontinue treatment.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
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)
Nitroglycerine (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nir Barak, MD
Organizational Affiliation
RDD Pharma Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Macabi outpatient clinic
City
Beer Sheba
State/Province
Negev
Country
Israel
Facility Name
Macabi outpatient clinic
City
Rehovot
Country
Israel
Facility Name
Macabi HMO outpatient clinic
City
Tel Aviv
Country
Israel
Facility Name
Asaf Harofe Hospital
City
Zrifin
Country
Israel
12. IPD Sharing Statement
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An Open Label Multi-Dose Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing
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