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/study/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
Treatment: Other - SAM-e (S-Adenosyl-L-Methionine)

Placebo comparator: P - Placebo Control Group


Treatment: Other: SAM-e (S-Adenosyl-L-Methionine)
One 400 mg tablet daily in the morning.
Intervention code [1] 0 0
Treatment: Other
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00528710