The Effect of Intra-anal Nifedipine, Used As Add-on to Conservative Therapy, on Pain in Patients With Anal Fissure
NCT02527109 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 339
Last updated 2018-10-23
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.
Conditions
- Chronic Anal Fissure
Interventions
- DRUG
-
Nifedipine
Sponsors & Collaborators
-
RDD Pharma Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-31
- Primary Completion
- 2018-06-15
- Completion
- 2018-08-22
Countries
- Bulgaria
- Moldova
- Poland
- Romania
Study Locations
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