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Trial record 28 of 143 for:    NIFEDIPINE

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

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ClinicalTrials.gov Identifier: NCT02527109
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
RDD Pharma Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Anal Fissure Drug: Nifedipine Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Intra-anal Nifedipine, Used As Add-on to Conservative Therapy, on Pain in Patients With Anal Fissure
Study Start Date : May 2016
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : August 22, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Nifedipine

Arm Intervention/treatment
Placebo Comparator: Placebo
Intra-anal placebo administered BID.
Drug: Nifedipine
Experimental: Nifedipine 12 mg/day
Intra-anal Nifedipine 12 mg administered OD.
Drug: Nifedipine
Experimental: Nifedipine 24 mg/day
Intra-anal Nifedipine 12 mg administered BID.
Drug: Nifedipine



Primary Outcome Measures :
  1. Rectal pain and measured by VAS [ Time Frame: measured at day 56 ]

Secondary Outcome Measures :
  1. Healing of anal fissure [ Time Frame: day 56 ]
    Healing is defined by lack of pain AND evidence of epithelization in a physical examination



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Subjects meeting the following criteria will be eligible to participate in the trial:

  1. Single anal fissure;
  2. Signed written informed consent;
  3. Male or female subjects 18 to 65 years of age inclusive;
  4. 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
    • Hypertrophied anal papilla
    • Exposure of the underlying internal anal sphincter
    • Anal cicatrisation
  5. Visual analogue scale of average 24 hours rectal pain (VAS) of > 40 mm in screening visit
  6. Capable of using the IVRS and able to adequately communicate comprehension of the IVRS questions to the investigator
  7. 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

Exclusion Criteria:

  • Subjects are excluded from participation in the study if any of the following criteria apply:

    1. Known allergy to Nifedipine
    2. Unwilling to stop all other concomitant topical preparations applied in and around the anus from screening through the end of the study
    3. Subfissure injection of botulinum toxin in the 3 months prior to screening.
    4. Fissure resulting from inflammatory bowel disease, venereal disease, perianal psoriasis, immunodeficiency syndrome
    5. Atypical fissure (occurs off the midline) in which secondary causes were not excluded.
    6. Deemed by the investigator as anal fissure for which surgery is indicated
    7. Anal abscess;
    8. Grade 4 hemorrhoids
    9. Fixed anal stenosis
    10. 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;
    11. Type 1 diabetes mellitus
    12. Insulin treated type 2 diabetes mellitus
    13. Renal failure defined as a serum creatinine > 1.5 mg/dL (133 µmol/L) at screening
    14. Liver disease defined as Aspartate aminotransferase (AST) or alanine aminotransferase(ALT) >2 X upper limit of normal at screening
    15. Malignant disease within 3 years of screening
    16. Has uncontrolled hypertension (sitting blood pressure >160/95 mmHg at screening)
    17. Has hypotension (blood pressure lower than 90/60 mm Hg at screening)
    18. History of chronic gastrointestinal disease such as Crohn's disease or ulcerative colitis
    19. History of major rectal surgery
    20. History of HIV, Hepatitis B, Hepatitis C
    21. Has clinical laboratory test values (chemistry, hematology, or urinalysis) judged to be clinically significant by the investigator at screening;
    22. 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
    23. Is treated with drugs that may affect the anal sphincter:

      1. Calcium channel blockers such as Nifedipine, Diltiazem or Verapamil
      2. Nitroglycerin or nitrates
    24. Has, upon physical examination, a rectal deformation or signs of rectal disease such as fistula, infection or space occupying lesion;
    25. Participated in a clinical study in the last 30 days prior to screening.
    26. 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527109


Locations
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Bulgaria
UMHAT "Sveti Georgi", Internal Consulting Department
Plovdiv, Bulgaria
"Multiprofile Hospital for Active Treatment - Doverie" AD, Clinic of Gastroenterology
Sofia, Bulgaria, 1632
II MHAT, Internal Clinic, Department of Gastroenterology
Sofia, Bulgaria
MC Health BG EOOD
Sofia, Bulgaria
Multiprofile Hospital for Active Treatment Lulin
Sofia, Bulgaria
MC "New rehabilitation centre'' EOOD
Stara Zagora, Bulgaria
"Multiprofile Regional Hospital for Active Treatment - Dr. St. Cherkezov" AD Department of Gastroenterology
Veliko Tarnovo, Bulgaria, 5002
Moldova, Republic of
IMSP Spitalul Clinic Municipal Nr 1
Chisinau, Moldova, Republic of
IMSP Spitalul Clinic Municipal Nr 3 "Sfanta Treime"
Chisinau, Moldova, Republic of
IMSP Spitalul Clinic Republican
Chisinau, Moldova, Republic of
Poland
Med-Gastr Centrum Medyczne
Lodz, Poland, 91-034
Ambulatorium Medyczne Medical Hair & Esthetic
Lublin, Poland, 20-844
Centrum Innowacyjnych Terapii Sp. z o.o. Oddział w Piasecznie
Piaseczno, Poland, 05-500
NZOZ Specjalistyczne Centrum Medyczne Flebo
Wolomin, Poland, 05-200
Romania
Pelican Impex SRL
Oradea, Jud. Bihor, Romania, 410469
IRGH
Cluj Napoca, Jud. Cluj, Romania, 400162
Tvm Med Serv Srl
Cluj Napoca, Jud. Cluj, Romania
Institutul Regional de Gastroenterologie si Hepatologie "Prof. Dr. Octavian Fodor"
Cluj-Napoca, Jud. Cluj, Romania, 400162
SC Schnelbach Medical Care SRL
Ploiesti, Jud. Prahova, Romania
Spit. Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta
Constanta, Judet Constanta, Romania
Dacmed SRL
Ploiesti, Judetul Prahova, Romania
Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
Brasov, Romania, 500283
Institutul Clinic Fundeni
Bucharest, Romania, 022328
Centrul Medical Sfanta Vineri SRL
Bucharest, Romania
Sponsors and Collaborators
RDD Pharma Ltd

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Responsible Party: RDD Pharma Ltd
ClinicalTrials.gov Identifier: NCT02527109     History of Changes
Other Study ID Numbers: RDD 110
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Nifedipine
Fissure in Ano
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents