Growth Hormone as Add-on Treatment in Severe Fibromyalgia With Low IGF-1 Serum Levels (56 Characters)

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Brief Title

Growth Hormone as Add-on Treatment in Severe Fibromyalgia With Low IGF-1 Serum Levels (56 Characters)

Official Title

Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia

Brief Summary

      There are evidences of functional growth hormone (GH) deficiency, expressed by means of low
      serum levels of insulin-like growth factor 1 (IGF-1), in a subset of fibromyalgia patients.
      The efficacy of low GH doses versus placebo has been demonstrated in this population. We
      assessed the efficacy and safety of GH added to standard therapy compared to standard therapy
      alone in the treatment of severe, prolonged and well-treated fibromialgya patients with low
      IGF-1 levels.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

reduction number of tender points (paired)

Secondary Outcome

 improvement in FIQ, EQ-5D , analogic visual scales (1). Safety (2).

Condition

Fibromyalgia

Intervention

sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group)


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug


Start Date

May 2004

Completion Date

November 2005


Eligibility Criteria

        Inclusion Criteria:

          -  Women greater than 18 years old with severe fibromyalgia and abnormally low IGF-1
             levels included in a rehabilitation and psychological program and stable under
             standard intensive treatment for at least 6 months.

          -  All patients fulfilled the 1990 ACR diagnostic criteria (1) and had an IGF-1 level
             <250 ng/mL (or 1 standard deviation bellow the mean value corresponding to age and
             body surface according to laboratory reference value).

          -  Other inclusion criteria were duration of fibromyalgia of 1 year or greater, pain in
             at least 16 (8 bilateral) of the 18 tender points and a score in the FIQ > 75.

          -  The study was conducted in accordance with the Declaration of Helsinki and received
             the local institutional review board and Spanish Drug Agency (nº03-0456) approvals.
             All patients gave written informed consent prior to their inclusion in the study.

        Exclusion Criteria:

          -  Disabling physical or mental status

          -  Previous or current malignancies, either active or inactive

          -  Intracranial space occupying lesion

          -  Any relevant endocrine disorder including diabetes mellitus

          -  History of another pituitary disorder

          -  Previous treatment with growth hormone

          -  Other systemic or joint inflammatory rheumatic conditions; and

          -  Known to be hypersensitive to somatropin or any of the excipients.

          -  Pregnant women, nursing mothers, or women with childbearing potential not using
             adequate contraceptive methods were also excluded.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Guillem Cuatrecasas, MD, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT00497562

Organization ID

FibTek-0301

Secondary IDs

03-0453 (AGEMED)


Study Sponsor

Centro Medico Teknon


Study Sponsor

Guillem Cuatrecasas, MD, Principal Investigator, CM Teknon Endocrinology Head Department


Verification Date

July 2007