Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00528710




Registration number
NCT00528710
Ethics application status
Date submitted
11/09/2007
Date registered
12/09/2007
Date last updated
12/09/2007

Titles & IDs
Public title
Efficacy of S-Adenosylmethionine in Fibromyalgia
Scientific title
Double-Blind, Placebo-Controlled Trial of the Impact of S-Adenosyl-L-Methionine (SAM-e) on the Mood and Other Symptoms in Fibromyalgia
Secondary ID [1] 0 0
DUHREC06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia Syndrome 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - SAM-e (S-Adenosyl-L-Methionine)

Placebo Comparator: P - Placebo Control Group


Other interventions: SAM-e (S-Adenosyl-L-Methionine)
One 400 mg tablet daily in the morning.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Symptom reduction in Fibromyalgia. Specifically we expect a reduction in depressive symptoms, sleep disturbances and gastric disturbances.
Timepoint [1] 0 0
Measured at three points in time: pre-trial and at 4 and 8 weeks
Secondary outcome [1] 0 0
Examination of dose-response data and the nature of the placebo effect in these conditions.
Timepoint [1] 0 0
Measured at three points in time: pre-trial and at 4 and 8 weeks

Eligibility
Key inclusion criteria
- Diagnosis of Fibromyalgia by a medical practitioner
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy, Manic and hypomanic conditions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Deakin University - Burwood
Recruitment postcode(s) [1] 0 0
3125 - Burwood

Funding & Sponsors
Primary sponsor type
Other
Name
Deakin University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Fundamentally, the trial aims to conduct a gold-standard test of the clinical impact of SAM-e
in the treatment of depressed mood and general symptoms of fibromyalgia (FMS).

As such, salient clinical and pathological parameters will be assessed over an 8-week period
in 60 patients who will be provided with either SAM-e or a placebo preparation . On the basis
of previous literature, it is hypothesised that patients in the active treatment group will
experience moderate but significant improvements across the clinical measures, and that these
gains will be significantly greater than any reported in the placebo group. All patients will
provide informed consent. All procedures will be conducted under medical supervision and the
preparation itself is very safe when used in the manner proposed for the trial
Trial website
https://clinicaltrials.gov/ct2/show/NCT00528710
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregory A Tooley, PhD
Address 0 0
Deakin University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00528710