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Self-Assessment Method for Statin Side-effects Or Nocebo (SAMSON)

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ClinicalTrials.gov Identifier: NCT02668016
Recruitment Status : Unknown
Verified August 2016 by Imperial College London.
Recruitment status was:  Recruiting
First Posted : January 29, 2016
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief 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.

Condition or disease Intervention/treatment Phase
Adverse Effects Cardiovascular Diseases Hyperlipidemias Drug: Atorvastatin Other: Placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Self-Assessment Method for Statin Side-effects Or Nocebo
Study Start Date : March 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atorvastatin 20mg Daily
Atorvastatin 20mg daily for 1 month
Drug: Atorvastatin
Atorvastatin 20mg tablets taken orally once daily for one month.
Other Names:
  • HMG CoA reductase inhibitors
  • Statins

Placebo Comparator: Placebo
Placebo daily for 1 month
Other: Placebo
Placebo tablets taken orally once daily for one month

No Intervention: No Treatment
No Atorvastatin or placebo for 1 month



Primary Outcome Measures :
  1. Individual Nocebo Proportion [ Time Frame: 12 months ]
    The individual nocebo proportion will be calculated at the end of the 12-months of the trial for each participant. The mean symptom scores for the four months on each arm will be calculated: placebo (mN) , Atorvastatin 20mg OD (mA) and no treatment (mZ). The Nocebo Proportion is (mN-mZ)/(mA-mZ). Let the averages of these standard deviations be respectively sA, sN, sZ. As long as mZ is small compared to mA and mN, and sA is not large in relation to mA, a reasonable approximation to the fractional standard error of the nocebo proportion will be calculated: (mN-mZ)/(mA-mZ) is (sA/mA + sN/mN) /112.


Secondary Outcome Measures :
  1. Currently prescribed statins [ Time Frame: 6-months after end of trial ]
    Following the end of the trial, is the trial participant taking statins or not.

  2. Attribution of adverse symptoms [ Time Frame: 6-months after end of trial ]
    Following the end of the trial, whether individual trial participants currently believe that most of the side-effects previously attributed to the statin, were indeed a pharmacological effect of the statin.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 years or older
  • Previously taken one or more statins
  • Withdrawn from statins because of perceived side effects
  • Developed side effects within 2 weeks of initiation
  • Clinical indication for statins for primary or secondary prevention of cardiovascular disease or dyslipidaemia, on either no medication or non-statin lipid lowering therapy (e.g, ezetimibe)

Exclusion Criteria:

  • History of neuropathy
  • Regularly taking prescribed analgesia
  • History of a chronic pain condition
  • History of severe mental illness (as their experience of symptoms may already be altered)
  • Current use of fibrates (because of the risk of interaction with statins but will not exclude participants taking ezetimibe).
  • Severe previous reaction or reaction considered immunological, such as anaphylaxis, facial swelling, severe rash, muscle ache with rise in serum creatine kinase, inflammatory myopathy, rhabdomyolysis or liver function abnormalities (aspartate transaminase (AST) or alanine transaminase (ALT) greater than 3 times upper limit or normal).
  • Side-effects taking longer than 2 weeks to develop (because in such participants much longer blocks of treatment would be required, if the present study is positive such studies will be planned for the future)*.
  • History of statin intolerance with drug interaction to antiretroviral drugs.
  • History of statin intolerance to any other drug.
  • Pregnant or breast feeding.
  • Side effects taking longer than 2 weeks to present.
  • In clinical judgement of study doctor, participant should not participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668016


Contacts
Contact: Frances A Wood, Bsc Mphil 02075949647 ext 49647 f.wood@imperial.ac.uk
Contact: James Howard, MA MB 02075949647 ext 49647 james@jph.am

Locations
United Kingdom
Imperial College London Recruiting
London, Greater London, United Kingdom, W12 0HS
Contact: Frances A Wood, Bsc RGN Mphil    0207 594 9647 ext 9647    f.wood@imperial.ac.uk   
Contact: David Thompson    0207 594 9647 ext 9647    david.thompson@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Darrel Francis, MB MD Imperial College London

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02668016     History of Changes
Other Study ID Numbers: 15SM2947
2015-004109-18 ( EudraCT Number )
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors