Chronic Anal FissurePhase 1/2NCT00972907
An Open Label Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing in Human Subjects
A Phase 1/2 study testing Nifedipine coated suppositories in people with Chronic Anal Fissure, run by RDD Pharma Ltd at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Anal Fissure
- What is being tested?
- Nifedipine coated suppositories
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesIsrael
- Study dates
- Dec 2009to Feb 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Anal Fissure
- Being tested
- Nifedipine coated suppositories
- Keywords
- anal fissure, pain, nifedipine
- Medical subject headings
- Fissure in Ano, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine coated suppositoriesDrug
12 mg Nifedipine coated suppositories BID
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Nifedipine coated suppositories BID. Receives: Drug: Nifedipine coated suppositories |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the effect of coated Nifedipine suppository on Anal fissure pain.
Measured: 8 weeks
To examine the effect of coated Nifedipine suppository on Anal fissure healing.
Measured: 8 weeks
Secondary outcomes (1)
To investigate the Safety and tolerability of coated Nifedipine suppositories in Anal Fissure patients.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Anal FissureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RDD Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972907
- Sponsor's protocol ID
- RDD 104
- Status last verified
- Feb 2011
- First submitted
- 8 Sep 2009
- Last updated
- 16 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing in Human Subjects
- ClinicalTrials.gov ID
- NCT00972907
- Acronym / sponsor ID
- RDD 104
- Conditions
- Chronic Anal Fissure
- Keywords
- anal fissure, pain, nifedipine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RDD Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Nifedipine coated suppositoriesNifedipine coated suppositories BID. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nifedipine coated suppositories12 mg Nifedipine coated suppositories BID | Drug | Treatment |
Primary outcome
To examine the effect of coated Nifedipine suppository on Anal fissure pain.
Time frame: 8 weeks
To examine the effect of coated Nifedipine suppository on Anal fissure healing.
Time frame: 8 weeks
1 secondary outcome
To investigate the Safety and tolerability of coated Nifedipine suppositories in Anal Fissure patients.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nifedipine coated suppositories in people with Chronic Anal Fissure, run by RDD Pharma Ltd at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the effect of coated Nifedipine suppository on Anal fissure pain. (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2011.