Anal FissurePhase 1/2NCT02023047
An Open Label Multi-Dose Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing
A Phase 1/2 study testing Nifedipine 12 mg coated suppositories in people with Anal Fissure, run by RDD Pharma Ltd at 4 sites in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anal Fissure
- What is being tested?
- Nifedipine 12 mg coated suppositories
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 4 sitesIsrael
- Study dates
- Mar 2014to Nov 2015
- 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 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.
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 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.
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Macabi outpatient clinic
Beersheba, Negev
Macabi outpatient clinic
Rehovot
Macabi HMO outpatient clinic
Tel Aviv, Tel Aviv
Asaf Harofe Hospital
Zrifin
About this study
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.
Read the 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.
- Conditions
- Anal Fissure
- Being tested
- Nifedipine 12 mg coated suppositories
- Keywords
- Anal Fissure, Nifedipine
- Medical subject headings
- Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine 12 mg coated suppositoriesDrug
| Study group | Role | What they receive |
|---|---|---|
| Once daily | Experimental | Nifedipine 12 mg Once daily Receives: Drug: Nifedipine 12 mg coated suppositories |
| Twice Daily | Experimental | Nifedipine 12 mg twice daily Receives: Drug: Nifedipine 12 mg 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 as measured by Visual Analog Score
Measured: 8 weeks after study initiation
Secondary outcomes (1)
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.
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 posted30 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Met primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDD Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nir Barak, MD, Study director, RDD Pharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023047
- Sponsor's protocol ID
- RDD 112
- Status last verified
- Jan 2015
- First submitted
- 11 Dec 2013
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Multi-Dose Study to Examine the Effect of Coated Nifedipine Suppository on Anal Fissure Pain and Healing
- ClinicalTrials.gov ID
- NCT02023047
- Acronym / sponsor ID
- RDD 112
- Conditions
- Anal Fissure
- Keywords
- Anal Fissure, Nifedipine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Met primary endpoint
- Enrolment
- 33 participants (actual)
- Lead sponsor
- RDD Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 30 Dec 2013 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Once daily | Experimental | Drug: Nifedipine 12 mg coated suppositoriesNifedipine 12 mg Once daily |
| Twice Daily | Experimental | Drug: Nifedipine 12 mg coated suppositoriesNifedipine 12 mg twice daily |
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 (34 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 12 mg coated suppositories | Drug | Once daily, Twice Daily |
Primary outcome
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
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 was stopped early (reason given: Met primary endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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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.
Nir Barak, MD study director
RDD Pharma Ltd
4 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 12 mg coated suppositories in people with Anal Fissure, run by RDD Pharma Ltd at 4 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 34 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: stopped early, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was stopped early (reason given: Met primary endpoint). Results are not available in the source record.
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 as measured by Visual Analog Score (time frame: 8 weeks after study initiation). 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 17 Nov 2015.