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Self-Assessment Method for Statin Side-effects Or Nocebo

NCT02668016 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-07

Study results available
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Summary

Front-line clinicians cannot currently test for an individual participant whether symptoms experienced are the pharmacological result of a statin or due to other phenomena. In this trial, participants who have previously ceased statins due to side effects will be offered the opportunity to undergo twelve randomly ordered 1-month periods. There will be four periods of no medication, four periods of placebo and four periods of statin. The placebo and the statin pills will be identical in appearance. Participants will record on a daily basis side-effects experienced. At the end of the study, the one-month sessions are sorted into the order shown above. The participant can then observe directly how much of the increase in symptoms seen with statin is also seen with placebo.

1. Hypothesis 1: that \>30% of participants enrolling for the study will complete it.
2. Hypothesis 2: Overall \>50% of symptom burden is nocebo rather than pharmacological
3. The investigators will define the Nocebo proportion of side effects.
4. Hypothesis 3: that the majority of participants, at 6 months after completion, will either be taking statins or have declined statins for reasons other than perceived side effects.

Conditions

Interventions

DRUG

Atorvastatin

Atorvastatin 20mg tablets taken orally once daily for one month.

OTHER

Placebo

Placebo tablets taken orally once daily for one month

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Darrel P Francis, MB MD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-10-31
Completion
2020-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

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 NCT02668016 on ClinicalTrials.gov