NCT02527109

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
339

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2016

Geographic Reach
4 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2018

Completed
Last Updated

October 23, 2018

Status Verified

June 1, 2018

Enrollment Period

2.1 years

First QC Date

August 10, 2015

Last Update Submit

October 21, 2018

Conditions

Chronic Anal Fissure

Outcome Measures

Primary Outcomes (1)

  • Rectal pain and measured by VAS

    measured at day 56

Secondary Outcomes (1)

  • Healing of anal fissure

    day 56

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Intra-anal placebo administered BID.

Drug: Nifedipine

Nifedipine 12 mg/day

EXPERIMENTAL

Intra-anal Nifedipine 12 mg administered OD.

Drug: Nifedipine

Nifedipine 24 mg/day

EXPERIMENTAL

Intra-anal Nifedipine 12 mg administered BID.

Drug: Nifedipine

Interventions

NifedipineDRUG
Nifedipine 12 mg/dayNifedipine 24 mg/dayPlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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
  • 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.
  • +9 more criteria

You may not qualify if:

  • 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.
  • 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
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

UMHAT "Sveti Georgi", Internal Consulting Department

Plovdiv, Bulgaria

Location

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

Sofia, 1632, Bulgaria

Location

II MHAT, Internal Clinic, Department of Gastroenterology

Sofia, Bulgaria

Location

MC Health BG EOOD

Sofia, Bulgaria

Location

Multiprofile Hospital for Active Treatment Lulin

Sofia, Bulgaria

Location

MC "New rehabilitation centre'' EOOD

Stara Zagora, Bulgaria

Location

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

Veliko Tarnovo, 5002, Bulgaria

Location

IMSP Spitalul Clinic Municipal Nr 1

Chisinau, Moldova

Location

IMSP Spitalul Clinic Municipal Nr 3 "Sfanta Treime"

Chisinau, Moldova

Location

IMSP Spitalul Clinic Republican

Chisinau, Moldova

Location

Med-Gastr Centrum Medyczne

Lodz, 91-034, Poland

Location

Ambulatorium Medyczne Medical Hair & Esthetic

Lublin, 20-844, Poland

Location

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

Piaseczno, 05-500, Poland

Location

NZOZ Specjalistyczne Centrum Medyczne Flebo

Wołomin, 05-200, Poland

Location

Pelican Impex SRL

Oradea, Jud. Bihor, 410469, Romania

Location

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

Cluj-Napoca, Jud. Cluj, 400162, Romania

Location

IRGH

Cluj-Napoca, Jud. Cluj, 400162, Romania

Location

Tvm Med Serv Srl

Cluj-Napoca, Jud. Cluj, Romania

Location

SC Schnelbach Medical Care SRL

Ploieşti, Jud. Prahova, Romania

Location

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

Constanța, Judet Constanta, Romania

Location

Dacmed SRL

Ploieşti, Prahova, Romania

Location

Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL

Brasov, 500283, Romania

Location

Institutul Clinic Fundeni

Bucharest, 022328, Romania

Location

Centrul Medical Sfanta Vineri SRL

Bucharest, Romania

Location

MeSH Terms

Interventions

Nifedipine

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 18, 2015

Study Start

May 1, 2016

Primary Completion

June 15, 2018

Study Completion

August 22, 2018

Last Updated

October 23, 2018

Record last verified: 2018-06

Locations

MO(3)PL(4)BU(7)RO(10)