FibromyalgiaPhase 2NCT00116129
Efficacy and Safety of an Oral Growth Hormone Drug in the Treatment of Fibromyalgia
A Phase 2 study testing Ibutamoren Mesylate (MK-0677) in people with Fibromyalgia, run by Bennett, Robert, M.D. at 1 site in United States.
Trial summary
This is a 24-week, randomized, double-blind, placebo-controlled, trial to evaluate the safety, tolerability and efficacy of an orally administered growth hormone stimulating drug, (code named MK-0677) in the treatment of female subjects with primary fibromyalgia. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Ibutamoren Mesylate (MK-0677)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Apr 2008
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will all be female primary fibromyalgia subjects who are 30 to 65 years of age, inclusive, and have a low age adjusted serum IGF-1 level.
- All subjects will fulfill a diagnosis of fibromyalgia according to the classification criteria of the American College of Rheumatology (ACR).
- All subjects will have an initial Fibromyalgia Impact Questionnaire (FIQ) score ≥ 40.
- If subject is of childbearing potential and sexually active, she agrees to use effective barrier or appropriate oral contraception during the study. Subjects who are taking oral contraceptives must have done so for at least 2 months prior to entering the study.
- Subject is not pregnant and is not nursing.
- Patient has a normal screening breast exam. If screening breast exam is abnormal, but not suggestive of breast cancer, the patient must have had a normal mammogram within the last 6 months.
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- Subject has a normal screening stool hemoccult. If the screening stool hemoccult is abnormal, but likely due to hemorrhoids, the subject must have had a normal sigmoidoscopy within the last 2 years.
- Subject is willing to discontinue using grapefruit juice for duration of study.
- Subject is willing to be followed by telephone contact for 3 months after she has discontinued study and completed and returned the Fibromyalgia Impact Questionnaire, Patient Global Change score, Quality of Life score, Brief Pain Inventory and Beck Depression Questionnaire.
Who cannot join
- Subject has an-ongoing, unresolved disability litigation.
- Subject has diabetes or a significantly elevated random glucose at the Screening visit.
- Subject has a current or past history of cardiovascular, pulmonary, neurological, endocrine or renal disease that would preclude involvement in an exercise program (specifically hypertension, a myocardial infarction within the last 6 months, chronic obstructive pulmonary disease [COPD], asthma, untreated hypothyroidism, severe depression with suicide risk, previous pituitary disease or surgery).
- Subject has a history of angina or congestive heart failure with symptoms that occur at rest.
- Subject has a history or current evidence of a psychotic disorder (e.g. schizophrenia), bipolar disorder or major depression, or substance abuse by DSM-IV criteria; severe depression, as evidenced by a Beck Depression score of ≥ 30.
- Subject has history of neurological disorder other than fibromyalgia (e.g. epilepsy, stroke, neuropathy, neuropathic pain).
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- Subject has ongoing symptoms of carpal tunnel syndrome.
- Subject has any other significant pain state, i.e. subject must have primary fibromyalgia.
- Subject has a history of hepatitis or liver disease that has been active within the past 12 weeks.
- Subject has cancer or a history of cancer within the past 2 years, or a history of cancer of more than 2 years ago and deemed to not be cured, or subject has ANY history of breast cancer. (NOTE: Subjects with a history of basal cell or squamous cell carcinoma of the skin treated more than 1 year ago and with no evidence of recurrence may participate.)
- Subject has abnormal thyroid stimulating-hormone, or T4 concentrations.
- Subject has a planned elective surgery during the study period.
- Subject has a history of hypersensitivity or idiosyncratic reaction to more than 2 drug classes (by chemical classification).
- Subject has abnormal Screening visit laboratory values.
- Subject is using any of the following medications : heparin, ticlopidine, ginko (in subjects taking warfarin), oral steroids (>/= 7 days per month), chronic use of strong CYP3A4 inhibitors (HIV protease inhibitors, macrolide antibiotics and nefazodone), chronic use of CYP3A4 inducers (carbamazepine, phenytoin, rifampin, and St. John's Wort).
- Subject has received an investigational drug or device within 30 days of study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-0677 25 mg in the Treatment of Primary Fibromyalgia
This is a 24-week, randomized, double-blind, placebo-controlled, trial to evaluate the safety, tolerability and efficacy of an orally administered growth hormone stimulating drug, (code named MK-0677) in the treatment of female subjects with primary fibromyalgia. The basis for this study is the observation that many fibromyalgia patients are growth hormone deficient; an earlier study of injectable growth hormone had shown benefit in this population of fibromyalgia patients.
Read the detailed description
This study examines whether MK-0677 treatment will improve symptoms of fibromyalgia (FM).
The rationale for this study is the observation that many fibromyalgia patients are growth hormone deficient in terms of low levels of IGF-1, and that improving IGF-1 levels with growth hormone injections has been shown to improve fibromyalgia symptoms.
MK-0677 is an orally administered growth hormone secretagogue manufactured by Merck \& Co., Inc. that acts on the growth hormone secretagogue receptor in the anterior pituitary to stimulate the release of growth hormone. This pathway represents an additional regulation of growth hormone release from pituitary somatotrophs to that mediated by growth hormone releasing hormone (stimulating) and somatostatin (inhibitory). Both stimulatory pathways lead to a pulsatile release of growth hormone, with approximately 4 hour intervals between peak levels. This growth hormone secretion leads to a rapid and robust up regulation of IGF-1 levels by about 50 to 100% that can be maintained with chronic therapy at a dose of 25 mg/day.
The primary aims of this study are:
- To evaluate the efficacy of MK-0677 25 mg in primary fibromyalgia subjects over a 24-week treatment period, as assessed by the FIQ.
- To evaluate the safety and tolerability of MK-0677 25 mg in subjects with fibromyalgia.
The secondary aims of this study are to determine whether:
- MK-0677 25 mg is superior to placebo in reducing muscle tenderness, as assessed by the Fibromyalgia Myalgic Score (FMyS).
- MK-0677 25 mg is superior to placebo in improving the subjects' global perception of change in fibromyalgia symptoms, as assessed by the Subjects' Global Impression of Change Questionnaire (PGIC).
- MK-0677 25 mg is superior to placebo in improving the subjects' quality of life, as assessed by the Quality of Life Questionnaire (QOL).
- Conditions
- Fibromyalgia
- Being tested
- Ibutamoren Mesylate (MK-0677)
- Keywords
- Fibromyalgia, Treatment, Growth hormone, IGF-1, MK-0677, Oral growth hormone secretagogue
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibutamoren Mesylate (MK-0677)Drug
Ibutamoren Mesylate 25 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Ibutamoren Mesylate (MK-0677) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MK-0677 25 mg is superior to placebo in reducing symptoms of fibromyalgia, as assessed by the Fibromyalgia Impact Questionnaire (FIQ) over a 24-week treatment period
Measured: Six months
MK-0677 25 mg is generally safe and well tolerated in subjects with fibromyalgia
Measured: Six months
Secondary outcomes (2)
MK-0677 25 mg is superior to placebo in improving the subjects' global perception of change in fibromyalgia symptoms, as assessed by the Subjects' Global Impression of Change Questionnaire (PGIC)
Measured: Six months
MK-0677 25 mg is superior to placebo in improving the subjects' quality of life, as assessed by the Quality of Life Questionnaire (QOL)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2005 (estimated)
- Study startJul 2005
- Primary completionJan 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bennett, Robert, M.D.
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Robert Bennett MD, Bennett, Robert, M.D.
- Investigators
- Robert Bennett, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116129
- Sponsor's protocol ID
- MK-0677/FM
- Other IDs
- IND 71,596
- Status last verified
- Aug 2012
- First submitted
- 27 Jun 2005
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bennett RM, Cook DM, Clark SR, Burckhardt CS, Campbell SM. Hypothalamic-pituitary-insulin-like growth factor-I axis dysfunction in patients with fibromyalgia. J Rheumatol. 1997 Jul;24(7):1384-9.
PubMed 9228141Bennett 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 9552084
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-0677 25 mg in the Treatment of Primary Fibromyalgia
- ClinicalTrials.gov ID
- NCT00116129
- Acronym / sponsor ID
- MK-0677/FM
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Treatment, Growth hormone, IGF-1, MK-0677, Oral growth hormone secretagogue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bennett, Robert, M.D.
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 28 Jun 2005 (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.
This is a 24-week, randomized, double-blind, placebo-controlled, trial to evaluate the safety, tolerability and efficacy of an orally administered growth hormone stimulating drug, (code named MK-0677) in the treatment of female subjects with primary fibromyalgia. The basis for this study is the observation that many fibromyalgia patients are growth hormone deficient; an earlier study of injectable growth hormone had shown benefit in this population of fibromyalgia patients.
Detailed description
This study examines whether MK-0677 treatment will improve symptoms of fibromyalgia (FM).
The rationale for this study is the observation that many fibromyalgia patients are growth hormone deficient in terms of low levels of IGF-1, and that improving IGF-1 levels with growth hormone injections has been shown to improve fibromyalgia symptoms.
MK-0677 is an orally administered growth hormone secretagogue manufactured by Merck \& Co., Inc. that acts on the growth hormone secretagogue receptor in the anterior pituitary to stimulate the release of growth hormone. This pathway represents an additional regulation of growth hormone release from pituitary somatotrophs to that mediated by growth hormone releasing hormone (stimulating) and somatostatin (inhibitory). Both stimulatory pathways lead to a pulsatile release of growth hormone, with approximately 4 hour intervals between peak levels. This growth hormone secretion leads to a rapid and robust up regulation of IGF-1 levels by about 50 to 100% that can be maintained with chronic therapy at a dose of 25 mg/day.
The primary aims of this study are:
- To evaluate the efficacy of MK-0677 25 mg in primary fibromyalgia subjects over a 24-week treatment period, as assessed by the FIQ.
- To evaluate the safety and tolerability of MK-0677 25 mg in subjects with fibromyalgia.
The secondary aims of this study are to determine whether:
- MK-0677 25 mg is superior to placebo in reducing muscle tenderness, as assessed by the Fibromyalgia Myalgic Score (FMyS).
- MK-0677 25 mg is superior to placebo in improving the subjects' global perception of change in fibromyalgia symptoms, as assessed by the Subjects' Global Impression of Change Questionnaire (PGIC).
- MK-0677 25 mg is superior to placebo in improving the subjects' quality of life, as assessed by the Quality of Life Questionnaire (QOL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Ibutamoren Mesylate (MK-0677)Placebo |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects will all be female primary fibromyalgia subjects who are 30 to 65 years of age, inclusive, and have a low age adjusted serum IGF-1 level.
- All subjects will fulfill a diagnosis of fibromyalgia according to the classification criteria of the American College of Rheumatology (ACR).
- All subjects will have an initial Fibromyalgia Impact Questionnaire (FIQ) score ≥ 40.
- If subject is of childbearing potential and sexually active, she agrees to use effective barrier or appropriate oral contraception during the study. Subjects who are taking oral contraceptives must have done so for at least 2 months prior to entering the study.
- Subject is not pregnant and is not nursing.
Key exclusion criteria (16 listed)
- Subject has an-ongoing, unresolved disability litigation.
- Subject has diabetes or a significantly elevated random glucose at the Screening visit.
- Subject has a current or past history of cardiovascular, pulmonary, neurological, endocrine or renal disease that would preclude involvement in an exercise program (specifically hypertension, a myocardial infarction within the last 6 months, chronic obstructive pulmonary disease [COPD], asthma, untreated hypothyroidism, severe depression with suicide risk, previous pituitary disease or surgery).
- Subject has a history of angina or congestive heart failure with symptoms that occur at rest.
- Subject has a history or current evidence of a psychotic disorder (e.g. schizophrenia), bipolar disorder or major depression, or substance abuse by DSM-IV criteria; severe depression, as evidenced by a Beck Depression score of ≥ 30.
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 |
|---|---|---|
| Ibutamoren Mesylate (MK-0677)Ibutamoren Mesylate 25 mg/day | Drug | Placebo |
Primary outcome
MK-0677 25 mg is superior to placebo in reducing symptoms of fibromyalgia, as assessed by the Fibromyalgia Impact Questionnaire (FIQ) over a 24-week treatment period
Time frame: Six months
MK-0677 25 mg is generally safe and well tolerated in subjects with fibromyalgia
Time frame: Six months
2 secondary outcomes
MK-0677 25 mg is superior to placebo in improving the subjects' global perception of change in fibromyalgia symptoms, as assessed by the Subjects' Global Impression of Change Questionnaire (PGIC)
Time frame: Six months
MK-0677 25 mg is superior to placebo in improving the subjects' quality of life, as assessed by the Quality of Life Questionnaire (QOL)
Time frame: Six months
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 Aug 2012.
- Background: PubMed 9228141Bennett RM, Cook DM, Clark SR, Burckhardt CS, Campbell SM. Hypothalamic-pituitary-insulin-like growth factor-I axis dysfunction in patients with fibromyalgia. J Rheumatol. 1997 Jul;24(7):1384-9.
- 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.
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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.
Robert Bennett, MD principal investigator
Oregon Health and Science University
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 Ibutamoren Mesylate (MK-0677) in people with Fibromyalgia, run by Bennett, Robert, M.D. at 1 site in United States.
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 9 inclusion and 16 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 Aug 2012. 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 United States. 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. Some participants in this study may receive a placebo. 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?
MK-0677 25 mg is superior to placebo in reducing symptoms of fibromyalgia, as assessed by the Fibromyalgia Impact Questionnaire (FIQ) over a 24-week treatment period (time frame: Six months). The study lists 2 primary outcomes in all. 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 NCT00116129, which also lists 2 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 Aug 2012.