An Open Label Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing in Human Subjects - Full Text View

Sponsor:	RDD Pharma Ltd
Information provided by:	RDD Pharma Ltd
ClinicalTrials.gov Identifier:	NCT00972907

Purpose

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.

Condition	Intervention	Phase
Chronic Anal Fissure	Drug: Nifedipine coated suppositories	Phase I Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing in Human Subjects

Resource links provided by NLM:

Drug Information available for: Nifedipine

U.S. FDA Resources

Further study details as provided by RDD Pharma Ltd:

Primary Outcome Measures:

To examine the effect of coated Nifedipine suppository on Anal fissure pain. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
To examine the effect of coated Nifedipine suppository on Anal fissure healing. [ Time Frame: 8 weeks ] [ 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 ]

Estimated Enrollment:	20
Study Start Date:	December 2009
Study Completion Date:	February 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment Nifedipine coated suppositories BID.	Drug: Nifedipine coated suppositories 12 mg Nifedipine coated suppositories BID

Detailed Description:

This is an open label study. The study will consist of 1 treatment group: coated Nifedipine suppository containing 12 mg of Nifedipine. Approximately 20 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) 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). 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 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 four 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972907

Locations

Israel
Sapir Medical Center
Kfar Saba, Israel
Macabi HMO
Tel Aviv, Israel

Sponsors and Collaborators

RDD Pharma Ltd

More Information

No publications provided

Responsible Party:	Nir Barak MD, RDD Pharma LTD
ClinicalTrials.gov Identifier:	NCT00972907 History of Changes
Other Study ID Numbers:	RDD 104
Study First Received:	September 8, 2009
Last Updated:	February 15, 2011
Health Authority:	Israel: Ethics Commission

Keywords provided by RDD Pharma Ltd:

anal fissure
pain
nifedipine

Additional relevant MeSH terms:

Fissure in Ano
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nifedipine
Tocolytic Agents
Reproductive Control Agents

Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012