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ICEF15

Clinical trials are studying ICEF15 in people with fecal incontinence, which means trouble controlling bowel movements. These studies aim to check how well ICEF15 works and how safe it is, especially in patients with external anal sphincter dysfunction. The main trial includes both female and male participants.

Table of Contents

Trial overview

The available trial data show one interventional study of ICEF15, called FI-3, Fidelia, with the identifier NCT04976153.[1] It is listed as authorised and is studying fecal incontinence in female and male patients.[1]

Who can participate

This study is designed for people with fecal incontinence, which means trouble controlling bowel movements.[1] The brief summary says the trial focuses on patients whose fecal incontinence is due to external anal sphincter dysfunction, caused by disruption and/or weakness of that muscle.[1]

The trial includes both female and male patients.[1] No other eligibility details are provided in the source data, so the main known target group is patients with this specific cause of fecal incontinence.[1]

What is being measured

The main outcome is the change in frequency of incontinence episodes.[1] Researchers measure this using bowel diary records, comparing the period before Visit 8, around target day 457, with the baseline period before implantation Visit 3, around target day 92.[1]

A bowel diary is a patient record of bowel movements and leakage episodes over time.[1] This helps the study team see whether the number of accidents goes down after treatment.[1]

Trial design and treatment groups

The study compares ICEF15 with placebo.[1] A placebo is a look-alike treatment used for comparison, so researchers can better judge whether changes are linked to ICEF15.[1]

Both treatments are given by intramuscular use, which means into a muscle.[1] The source data also list the study as interventional, meaning the researchers actively give a treatment and then observe the results.[1]

Study phase and size

The trial is in Phase 3.[1] Phase 3 studies are later-stage trials that usually involve more people and are meant to test how well a treatment works while continuing to watch safety.[1]

The planned enrollment is 286 participants.[1] This size suggests the researchers want enough data to make a stronger assessment of the treatment effect in the target population.[1]

What the results aim to show

The brief summary states that the main objective is the final assessment of clinical efficacy and clinical safety of ICEF15 therapy for patients with fecal incontinence caused by external anal sphincter dysfunction.[1] Clinical efficacy means how well the treatment works in the study, and clinical safety means how safely it can be used in participants.[1]

In simple terms, the trial is asking whether ICEF15 can help reduce bowel leakage and whether it can do so safely in the studied group.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04976153 Phase 3 Fecal incontinence in female and male patients Authorised 286

FAQ

  • What are clinical trials of ICEF15 studying? They are studying whether ICEF15 can reduce fecal incontinence episodes. The main focus is on clinical efficacy and clinical safety.
  • Who can take part in the ICEF15 trial? The main trial includes female and male patients with fecal incontinence. It is aimed at patients whose condition is linked to external anal sphincter dysfunction, meaning weakness or disruption of the muscle that helps control bowel movements.
  • What phase is the ICEF15 trial? The main trial is a Phase 3 study. Phase 3 trials usually test whether a treatment works in a larger group of people and continue to monitor safety.
  • What is the main outcome being measured? The trial measures changes in the number of incontinence episodes. It compares bowel diary records before treatment and later in the study.
  • How many people are planned for the ICEF15 study? The study plans to include 286 participants. This gives the researchers a larger group to evaluate results.

Ongoing Clinical Trials on ICEF15

  • Study on ICEF15 for Treating Fecal Incontinence in Patients with Anal Sphincter Dysfunction

    Recruiting

    1 1 1
    Investigated drugs:
    Austria Bulgaria Czechia France Germany Italy +4

Glossary

  • Fecal incontinence: A condition where a person cannot fully control bowel movements, which can lead to accidental leakage.
  • External anal sphincter: A muscle around the anus that helps keep stool inside the body until a person is ready to pass it.
  • Dysfunction: A problem where a body part does not work as it should.
  • Disruption: Damage or breaking of a tissue or structure.
  • Weakness: Reduced strength, which can make a muscle work less well.
  • Phase 3: A later stage of clinical research that studies how well a treatment works and how safe it is in more people.
  • Placebo: A look-alike treatment with no active study drug, used to compare results fairly.
  • Interventional study: A study where researchers give a treatment or procedure and then measure what happens.
  • Bowel diary: A record kept by patients to track bowel movements and incontinence episodes over time.
  • Baseline period: The starting time before treatment begins, used as a comparison point.
  • Clinical efficacy: How well a treatment works in real study conditions.
  • Clinical safety: How safely a treatment can be used in study participants.

References