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Finding the Best Dose of Aspirin to Prevent Lynch Syndrome Cancers

NCT02497820 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2016-08-25

No results posted yet for this study

Summary

A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg versus 100mg of enteric coated aspirin as a cancer preventive in carriers of a germline pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention Programme (CaPP3).

Conditions

  • Lynch Syndrome I (Site-specific Colonic Cancer)

Interventions

DRUG

Aspirin

Aspirin (acetylsalicylic acid) has a marketing approval for use in the EU and is widely available as an over the counter medicine. However it is not being used within its licensed indication and the aspirin (at any dose in this study) will be treated as an investigational medicinal product (IMP). Tablets will be provided as enteric-coated 100mg or 300mg tablets for oral use. All patients will receive at least some dose of aspirin but blinding to the actual dose will be achieved by the use of 'dummy' tablets using the same excipients as in the active formulation of the aspirin minus the active ingredient. The aspirin and dummy tablets should be stored at room temperature below 25⁰C in a dry place.

Sponsors & Collaborators

  • Rambam Health Care Campus

    collaborator OTHER

  • Rabin Medical Center

    collaborator OTHER

  • Soroka University Medical Center

    collaborator OTHER

  • Sheba Medical Center

    collaborator OTHER_GOV

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Nadir Arber, MD, MSc, MHA · Tel-Aviv Sourasky Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • Israel

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02497820 on ClinicalTrials.gov