Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116129
Status:
COMPLETED
Last Update Posted:
2012-08-06
First Post:
2005-06-27
Brief Title:
Efficacy and Safety of an Oral Growth Hormone Drug in the Treatment of Fibromyalgia
Sponsor:
Bennett Robert MD
Organization:
Bennett Robert MD
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 mgday
The primary aims of this study are
1 To evaluate the efficacy of MK-0677 25 mg in primary fibromyalgia subjects over a 24-week treatment period as assessed by the FIQ
2 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
1 MK-0677 25 mg is superior to placebo in reducing muscle tenderness as assessed by the Fibromyalgia Myalgic Score FMyS
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
3 MK-0677 25 mg is superior to placebo in improving the subjects quality of life as assessed by the Quality of Life Questionnaire QOL
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 mgday
The primary aims of this study are
1 To evaluate the efficacy of MK-0677 25 mg in primary fibromyalgia subjects over a 24-week treatment period as assessed by the FIQ
2 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
1 MK-0677 25 mg is superior to placebo in reducing muscle tenderness as assessed by the Fibromyalgia Myalgic Score FMyS
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
3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND 71596 | None | None | None |