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Chronic Anal FissurePhase 2/3NCT02527109

The Effect of Intra-anal Nifedipine, Used As Add-on to Conservative Therapy, on Pain in Patients With Anal Fissure

A Phase 2/3 study testing Nifedipine in people with Chronic Anal Fissure, run by RDD Pharma Ltd at 24 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of the study is to examine the effect of Nifedipine, applied intra-anally through our drug delivery device, on rectal pain severity in anal fissure patients that are being managed with conservative treatment. 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
339 participants
Where
24 sitesin 4 countries
Study dates
May 2016to 22 Aug 2018
Phase
Phase 2/3
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

  • Subjects meeting the following criteria will be eligible to participate in the trial:
  • Single anal fissure;
  • Signed written informed consent;
  • Male or female subjects 18 to 65 years of age inclusive;
  • Has chronic anal fissure defined as history of rectal pain at least three days a week for at least 6 weeks - or more AND at least one of the following:
  • Sentinel skin tag
Show all 24Show fewer
  • Hypertrophied anal papilla
  • Exposure of the underlying internal anal sphincter
  • Anal cicatrisation
  • Visual analogue scale of average 24 hours rectal pain (VAS) of > 40 mm in screening visit
  • Capable of using the IVRS and able to adequately communicate comprehension of the IVRS questions to the investigator
  • 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 acceptable birth control from screening and until 1 week after the study medication has been discontinued.
  • Acceptable birth control includes :
  • combined (estrogen and progestogen containing) hormonal contraception
  • associated with inhibition of ovulation; oral OR intravaginal OR transdermal.
  • progestogen-only hormonal contraception associated with inhibition of ovulation: oral OR injectable OR implantable.
  • progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
  • intrauterine device (IUD)
  • intrauterine hormone-releasing system ( IUS)
  • bilateral tubal occlusion
  • vasectomised partner
  • sexual abstinence
  • male or female condom with or without spermicide
  • cap, diaphragm or sponge with spermicide

Who cannot join

  • Subjects are excluded from participation in the study if any of the following criteria apply:
  • Known allergy to Nifedipine
  • Unwilling to stop all other concomitant topical preparations applied in and around the anus from screening through the end of the study
  • Subfissure injection of botulinum toxin in the 3 months prior to screening.
  • Fissure resulting from inflammatory bowel disease, venereal disease, perianal psoriasis, immunodeficiency syndrome
  • Atypical fissure (occurs off the midline) in which secondary causes were not excluded.
Show all 29Show fewer
  • Deemed by the investigator as anal fissure for which surgery is indicated
  • Anal abscess;
  • Grade 4 hemorrhoids
  • Fixed anal stenosis
  • Active or past history of cardiovascular or cerebrovascular disease including but not limited to angina pectoris, myocardial infarction, transient ischemic attacks/stroke, arrhythmia or ecg changes that requires medical treatment or deemed by the investigator as clinically significant, moderate to severe congestive heart failure, or cardiac valve abnormalities;
  • Type 1 diabetes mellitus
  • Insulin treated type 2 diabetes mellitus
  • Renal failure defined as a serum creatinine > 1.5 mg/dL (133 µmol/L) at screening
  • Liver disease defined as Aspartate aminotransferase (AST) or alanine aminotransferase(ALT) >2 X upper limit of normal at screening
  • Malignant disease within 3 years of screening
  • Has uncontrolled hypertension (sitting blood pressure >160/95 mmHg at screening)
  • Has hypotension (blood pressure lower than 90/60 mm Hg at screening)
  • History of chronic gastrointestinal disease such as Crohn's disease or ulcerative colitis
  • History of major rectal surgery
  • History of HIV, Hepatitis B, Hepatitis C
  • Has clinical laboratory test values (chemistry, hematology, or urinalysis) judged to be clinically significant by the investigator at screening;
  • 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 Rivaroxaban, Apixaban, Edoxaban
  • Is treated with drugs that may affect the anal sphincter:
  • Calcium channel blockers such as Nifedipine, Diltiazem or Verapamil
  • Nitroglycerin or nitrates
  • Has, upon physical examination, a rectal deformation or signs of rectal disease such as fistula, infection or space occupying lesion;
  • Participated in a clinical study in the last 30 days prior to screening.
  • 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 or related to the Sponsor, CRO or investigator;

Trial locations and contacts

24 sites in 4 countries.

24 sites in 4 countries

Romania10 sites

  • Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL

    Brasov, 500283

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Centrul Medical Sfanta Vineri SRL

    Bucharest

  • Institutul Regional de Gastroenterologie si Hepatologie "Prof. Dr. Octavian Fodor"

    Cluj-Napoca, Jud. Cluj, 400162

  • IRGH

    Cluj-Napoca, Jud. Cluj, 400162

  • Tvm Med Serv Srl

    Cluj-Napoca, Jud. Cluj

  • Spit. Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta

    Constanța, Judet Constanta

  • Pelican Impex SRL

    Oradea, Jud. Bihor, 410469

  • SC Schnelbach Medical Care SRL

    Ploieşti, Jud. Prahova

  • Dacmed SRL

    Ploieşti, Prahova

Other trials in Romania

Bulgaria7 sites

  • UMHAT "Sveti Georgi", Internal Consulting Department

    Plovdiv

  • "Multiprofile Hospital for Active Treatment - Doverie" AD, Clinic of Gastroenterology

    Sofia, 1632

  • II MHAT, Internal Clinic, Department of Gastroenterology

    Sofia

  • MC Health BG EOOD

    Sofia

  • Multiprofile Hospital for Active Treatment Lulin

    Sofia

  • MC "New rehabilitation centre'' EOOD

    Stara Zagora

  • "Multiprofile Regional Hospital for Active Treatment - Dr. St. Cherkezov" AD Department of Gastroenterology

    Veliko Tarnovo, 5002

Other trials in Bulgaria

Poland4 sites

  • Med-Gastr Centrum Medyczne

    Lodz, 91-034

  • Ambulatorium Medyczne Medical Hair & Esthetic

    Lublin, 20-844

  • Centrum Innowacyjnych Terapii Sp. z o.o. Oddział w Piasecznie

    Piaseczno, 05-500

  • NZOZ Specjalistyczne Centrum Medyczne Flebo

    Wołomin, 05-200

Other trials in Poland

Moldova3 sites

  • IMSP Spitalul Clinic Municipal Nr 1

    Chisinau

  • IMSP Spitalul Clinic Municipal Nr 3 "Sfanta Treime"

    Chisinau

  • IMSP Spitalul Clinic Republican

    Chisinau

Other trials in Moldova

About this study

The objective of the study is to examine the effect of Nifedipine, applied intra-anally through our drug delivery device, on rectal pain severity in anal fissure patients that are being managed with conservative treatment.

Read the detailed description

This is a randomized, double-blinded study. All patients in the study will be treated with the conservative standard of care for anal fissure. Study medication will be used as an add-on to conservative therapy, and will consist of 3 groups:

  1. Treatment Group 1- 12 mg of Nifedipine to be self-administered twice daily.
  2. Treatment Group 2- 12 mg of Nifedipine to be self-administered once daily in the morning hours and placebo to be self-administered in the evening.
  3. Placebo Group - Placebo to be self-administered twice daily. Approximately 330 subjects will participate in this 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 either Nifedipine 12 mg X2 a day (BID) (24 mg/day total) or Nifedipine 12 mg X1/day to be administered in the morning hours and a matching placebo X1/day to be administered in the evening hours (12 mg/day total) or a matching placebo X2 a day (BID) (0 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 and placebo will be administered BID (in the morning and in the evening). In addition to receiving study medication, subjects will be maintained on a conservative standard treatment for Anal Fissure: sitz baths, high fiber diet, stool softeners and plenty of fluids.

Upon completion of the treatment cycle, patients will be contacted by phone (at weeks 10, 13 and 16) and will be questioned about recurrent symptoms e.g. pain or bleeding.

Patients that:

  1. Were enrolled to one of the investigational groups ,and completed the 8 weeks treatment period or discontinued treatment because the investigator deemed them as healed AND
  2. Experience symptoms of recurrence AND ARE
  3. Willing to participate in an open label extension will receive Nifedipine 12 mg X2 a day (BID) for a period of 8 weeks. During this period, 4 study visits (at 0, 2, 5, and 8 weeks from the start of retreatment) will take place.
Being tested
Nifedipine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NifedipineDrug

Study groups in NCT02527109
Study groupRoleWhat they receive
PlaceboPlacebo comparatorIntra-anal placebo administered BID.
Receives: Drug: Nifedipine
Nifedipine 12 mg/dayExperimentalIntra-anal Nifedipine 12 mg administered OD.
Receives: Drug: Nifedipine
Nifedipine 24 mg/dayExperimentalIntra-anal Nifedipine 12 mg administered BID.
Receives: Drug: Nifedipine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rectal pain and measured by VAS

    Measured: measured at day 56

Secondary outcomes (1)

  1. Healing of anal fissure

    Healing is defined by lack of pain AND evidence of epithelization in a physical examination

    Measured: day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2015 (estimated)
  2. Study startMay 2016
  3. Primary completion15 Jun 2018
  4. Study completion22 Aug 2018

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
339 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02527109
Sponsor's protocol ID
RDD 110
Status last verified
Jun 2018
First submitted
10 Aug 2015
Last updated
23 Oct 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Nifedipine in people with Chronic Anal Fissure, run by RDD Pharma Ltd at 24 sites in 4 countries.

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 24 inclusion and 29 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 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Romania, Bulgaria, Poland, Moldova. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Rectal pain and measured by VAS (time frame: measured at day 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02527109.

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 23 Oct 2018.

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