FibromyalgiaPhase 2NCT00497562
Growth Hormone as Add-on Treatment in Severe Fibromyalgia With Low IGF-1 Serum Levels (56 Characters)
A Phase 2 study testing sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group) in people with Fibromyalgia and Growth Hormone Deficiency, run by Centro Medico Teknon at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Growth Hormone Deficiency
- What is being tested?
- sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group)
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- May 2004to Nov 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia
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.
- Conditions
- Fibromyalgia, Growth Hormone Deficiency
- Being tested
- sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group), amitriptyline, fluoxetine and tramadol alone (control group)
- Keywords
- Fibromyalgia, growth hormone, IGF-1, FIQ
- Medical subject headings
- Fibromyalgia, Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group)Drug
amitriptyline, fluoxetine and tramadol alone (control group)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction number of tender points (paired)
Measured: one year treatment
Secondary outcomes (1)
improvement in FIQ, EQ-5D , analogic visual scales (1). Safety (2).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startMay 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Centro Medico Teknon
- Sponsor type
- University, hospital or other
- Investigators
- Guillem Cuatrecasas, MD, Principal investigator, CM Teknon Endocrinology Head DepartmentAlbert Nadal, MD, Study chair, CM Teknon Rheumatology Head Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497562
- Sponsor's protocol ID
- FibTek-0301
- Other IDs
- 03-0453 (AGEMED)
- Status last verified
- Jul 2007
- First submitted
- 5 Jul 2007
- Last updated
- 6 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bennett RM, Clark SC, Walczyk J. A randomized, double-blind, placebo-controlled study of growth hormone in the treatment of fibromyalgia. Am J Med. 1998 Mar;104(3):227-31. doi: 10.1016/s0002-9343(97)00351-3.
PubMed 9552084Leal-Cerro A, Povedano J, Astorga R, Gonzalez M, Silva H, Garcia-Pesquera F, Casanueva FF, Dieguez C. The growth hormone (GH)-releasing hormone-GH-insulin-like growth factor-1 axis in patients with fibromyalgia syndrome. J Clin Endocrinol Metab. 1999 Sep;84(9):3378-81. doi: 10.1210/jcem.84.9.5982.
PubMed 10487713Cuatrecasas G, Riudavets C, Guell MA, Nadal A. Growth hormone as concomitant treatment in severe fibromyalgia associated with low IGF-1 serum levels. A pilot study. BMC Musculoskelet Disord. 2007 Nov 30;8:119. doi: 10.1186/1471-2474-8-119.
PubMed 18053120
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia
- ClinicalTrials.gov ID
- NCT00497562
- Acronym / sponsor ID
- FibTek-0301
- Conditions
- Fibromyalgia, Growth Hormone Deficiency
- Keywords
- Fibromyalgia, growth hormone, IGF-1, FIQ
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Centro Medico TeknonUniversity, hospital or other
- Study start
- May 2004
- Study completion
- Nov 2005 (actual)
- First posted
- 6 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group) | Drug | – |
| amitriptyline, fluoxetine and tramadol alone (control group) | Drug | – |
Primary outcome
reduction number of tender points (paired)
Time frame: one year treatment
1 secondary outcome
improvement in FIQ, EQ-5D , analogic visual scales (1). Safety (2).
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2007.
- Background: PubMed 9552084Bennett RM, Clark SC, Walczyk J. A randomized, double-blind, placebo-controlled study of growth hormone in the treatment of fibromyalgia. Am J Med. 1998 Mar;104(3):227-31. doi: 10.1016/s0002-9343(97)00351-3.
- Background: PubMed 10487713Leal-Cerro A, Povedano J, Astorga R, Gonzalez M, Silva H, Garcia-Pesquera F, Casanueva FF, Dieguez C. The growth hormone (GH)-releasing hormone-GH-insulin-like growth factor-1 axis in patients with fibromyalgia syndrome. J Clin Endocrinol Metab. 1999 Sep;84(9):3378-81. doi: 10.1210/jcem.84.9.5982.
- Derived from this study: PubMed 18053120Cuatrecasas G, Riudavets C, Guell MA, Nadal A. Growth hormone as concomitant treatment in severe fibromyalgia associated with low IGF-1 serum levels. A pilot study. BMC Musculoskelet Disord. 2007 Nov 30;8:119. doi: 10.1186/1471-2474-8-119.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillem Cuatrecasas, MD principal investigator
CM Teknon Endocrinology Head Department
Albert Nadal, MD study chair
CM Teknon Rheumatology Head Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group) in people with Fibromyalgia and Growth Hormone Deficiency, run by Centro Medico Teknon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction number of tender points (paired) (time frame: one year treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00497562, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2007.