Trial document




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  DRKS00008024

Trial Description

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Title

Efficacy of Spironolactone in Fibromyalgia

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Trial Acronym

ESiF

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URL of the Trial

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Brief Summary in Lay Language

The efficacy of spironolactone, a drug which is commonly used against edema, against fibromyalgia will be studied in 56 patients.
Amendment: In study protocol v1.1.4 (dated 3.1.2017) the previous age range was extend to 75 years; the laboratory was changed; the insurance broker was changed; the drug labelling was extended. All changes were approved by BfArM on 30.1.2017.

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Brief Summary in Scientific Language

56 patients with fibromyalgia will be recruited. Their diagnosis will be confirmed by ACR 2010, the impact of the disaese will be classified by FIQ-G.
After 6 days of increasing the dosages, patients stay on 200 mg spironolactone per day or placebo (randomized, controlled study design). There are visits 1 and 2, 4 and 6 weeks for assessment of efficacy and adverse events.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00008024
  •   2015/08/17
  •   [---]*
  •   yes
  •   Approved
  •   A110/15, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

  •   U1111-1169-6403 
  •   2014-003350-13 
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Health Condition or Problem studied

  •   M79.7 -  Fibromyalgia
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Interventions/Observational Groups

  •   Aldactone(R) 50, Spironolactone (increasing dosages day 1 to 6) up to 200 mg/d p.o. for 28 days
  •   Placebo (Dosage of tablets like verum)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   Yes
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Primary Outcome

Reduction of FIQ-G-Scores (Fibromyalgia Impact Questionnaire, German version) after 4 weeks of treatment

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Secondary Outcome

Reduction of pain (numeric rating scala, NRS) after 4 weeks
Improvement of mood (ADS) after 4 weeks
Improvement of quality of life (SF-36) after 4 weeks
Raise in Fibromyalgia Impact Questionnaire (FIQ) Scores after 6 weeks
Reduction of current analgetic comedication after 4 weeks
Assesment of variability of the plasmaconcentration of the active metabolite of spironolactone after 4 weeks, correlation with scores mentioned above

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/12/01
  •   56
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

Fibromyalgia, diagnosed according to ACR 2010
Blood test normal: creatinin, eGFR > 60 ml/min.
No known Diabetes mellitus, no known renal disease.
BMI > 18 kg/m²
No other serious pathological findings in patient history concerning cardio-vascular, renal, pulmonal, haematopoetic, hepatic, endocrin or neuronal functions
Written consent after education about course of events and risks of this study
Negative pregnancy test
Effective (Pearl Index < 1%) contraception measures (inhibitors of ovulation, heterosexual abstinence, menopause, vasectomized partner, bilateral tube occlusion, or combination of two less effective measures)

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Exclusion Criteria

Known allergic reaction to the study medication (Aldactone® 50 (contains yellow-orange S) or Sinupret eXtract® placebos).
Hypotension (RR < 105/75 mmHg or MAD < 85 mmHg)
Hypovolemia
Blood test abnormal (as judged by the investigator): electrolytes (Na, K, Cl, Ca), liver function tests (ASAT, gGT), blood cell count.
Pregnancy / lactation period.
Expected noncompliance.
Differences between self-reported chronic medication usage and qualitative findings of medication usage in urine.
Contraindications to the study medication.
Concomitant use of ACE-inhibitors/ARB, potassium-sparing diuretics or potassium substitution.
Long-time (> 10 days) use of NSAID.
Other conditions that render the subject inapt for this study according to the investigator.
Concomitant participation in other clinical trials (self-reporting).

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Addresses

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    • Universitätsklinikum Schleswig-Holstein (UKSH)
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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    • Institut für Experimentelle und Klinische Pharmakologie, UKSH, Campus Kiel
    • Mr.  Dr. med.  Ruwen  Böhm 
    • Hospitalstr. 5
    • 24105  Kiel
    • Germany
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    • Institut für Experimentelle und Klinische Pharmakologie
    • Mr.  Dr. med.  Ruwen  Böhm 
    • Haus 30, Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Experimentelle und Klinische Pharmakologie, UKSH Campus Kiel
    • Mr.  Prof. Dr.  Thomas  Herdegen 
    • Arnold-Heller-Str. 3, Haus 30
    • 24105  Kiel
    • Germany
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    • RIEMSER Pharma GmbH
    • An der Wiek 7
    • 17493  Greifswald
    • Germany
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    • Klinik für Anästhesiologie und Operative Intensivmedizin, UKSH Campus Kiel
    • Mr.  Prof. Dr. med.  Markus  Steinfath 
    • Schwanenweg 21
    • 24105  Kiel
    • Germany
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    •   0431 500 20701
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    • Bionorica SE
    • Prof. Dr.  Michael  Popp 
    • Kerschensteinerstraße 11-15
    • 92318  Neumarkt
    • Germany
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    • Omnicell GmbH
    • Mr.  Michael  Felski 
    • Robert-Bosch-Straße 7
    • 64293  Darmstadt
    • Germany
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    •   06151 8001651
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Status

  •   Recruiting complete, follow-up complete
  •   2018/11/23
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Trial Publications, Results and other Documents

  •   Wernze, Heinrich, and Thomas Herdegen. "Long-term efficacy of spironolactone on pain, mood, and quality of life in women with fibromyalgia: An observational case series." Scandinavian Journal of Pain 5.2 (2014): 63-71.
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