Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000071325
Ethics application status
Approved
Date submitted
19/11/2007
Date registered
8/02/2008
Date last updated
17/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Before and after clinical trial of Neourotec on patient with fibromyalgia
Scientific title
Before & after clinical trial of Neurotec's (a pharmasutical drug) on reducing pain in patients with fibromyalgia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgic disorder 2528 0
Condition category
Condition code
Musculoskeletal 2625 2625 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neurotec administered orally, one capsules containing 100mg of effective substance every 12 hours for 8 weeks. Totally 112 capsule will consume with volunteers during 56 days. Subjects evaluate on bi-weekly basis during treatment and also 4 & 8 weeks after treatment.
Intervention code [1] 2257 0
Treatment: Drugs
Intervention code [2] 2258 0
Not applicable
Comparator / control treatment
self control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3536 0
Pain Assessment against Visual Analogus Scale
Timepoint [1] 3536 0
at baseline and at 2, 4, 6, and 8 weeks after intervention commencement
Secondary outcome [1] 5916 0
Psychological examination (interview) based on the Diagnostic and Statistical Manual of Mental Disorders version 4 (DSM-IV)
Timepoint [1] 5916 0
at baseline and at 2, 4, 6, and 8 weeks after intervention commencement
Secondary outcome [2] 5917 0
Gastrointestinal examination
Timepoint [2] 5917 0
at baseline and at 2, 4, 6, and 8 weeks after intervention commencement

Eligibility
Key inclusion criteria
Fibromyalgic disorder symptoms based on USA Rheumatologic association' criteria
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nonvolunteers
Hypothyroidism
Rheumatologic disorders
Psychotic disorders
Sever Congestive Heart Failer (CHF)
Sever and chronic ischemic heart disorder with pulsless limb
Sever disease: Cancers, Vasculitis
Alcohol or Drug abuse
Chronic renal failer
Dialysis
Sever hepatic failer
Treatment with corticosteroids
Immuno suppressive therapy
Radiotherapy
Chemotherapy
Any hypersentivity disorder
Electrolytes disorder

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Patient with fibromyalgic symptoms examine with neurologist and rheumatoligist separately and include based on US Rheumatologic association criteria
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 646 0
Iran, Islamic Republic Of
State/province [1] 646 0
Tehran
Country [2] 647 0
Iran, Islamic Republic Of
State/province [2] 647 0
Tehran

Funding & Sponsors
Funding source category [1] 2807 0
Commercial sector/Industry
Name [1] 2807 0
Parsroos Co.
Country [1] 2807 0
Iran, Islamic Republic Of
Primary sponsor type
Hospital
Name
Rhuematologic Ward
Address
Tehran University of Medical Sciences
Kargar Ave,Shariati Hospital
Rhuematologic Ward
Tehran ,Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 2537 0
Other Collaborative groups
Name [1] 2537 0
Rhuematologic Research Center
Address [1] 2537 0
Tehran University of Medical Sciences
Rhuematologic Research Center
Kargar Ave,Shariati Hospital
Tehran ,Iran
Country [1] 2537 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4731 0
Digestive Disease Research Center, Ethical Committee
Ethics committee address [1] 4731 0
Tehran University of Medical Sciences
Digestive Disease Research Center
Kargar Ave,Shariati Hospital
Tehran ,Iran
Ethics committee country [1] 4731 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 4731 0
14/07/2007
Approval date [1] 4731 0
13/09/2007
Ethics approval number [1] 4731 0
FWA00001331
Ethics committee name [2] 4732 0
Digestive Disease Research Center, Ethics Committee
Ethics committee address [2] 4732 0
Ethics committee country [2] 4732 0
Date submitted for ethics approval [2] 4732 0
Approval date [2] 4732 0
Ethics approval number [2] 4732 0

Summary
Brief summary
Evaluate the safety and efficacy effect of Neurotec on fibromyalgia and its signs and symptoms. It is hypothesized that Neurotec is a safe drug and effective in reducing the pain, GI disorder, sleep disorder and treatment of Fibromialgia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28164 0
Address 28164 0
Country 28164 0
Phone 28164 0
Fax 28164 0
Email 28164 0
Contact person for public queries
Name 11321 0
Dr. Ali Dehghan
Address 11321 0
Tehran University of Medical Sciences
Rhuematologic Research Center
Kargar Ave,Shariati Hospital
Tehran ,Iran
Country 11321 0
Iran, Islamic Republic Of
Phone 11321 0
0098-912-5146500
Fax 11321 0
+ 98 21 8802 6956
Email 11321 0
[email protected]
Contact person for scientific queries
Name 2249 0
Dr. Ahmadreza Jamshidi
Address 2249 0
Tehran University of Medical Sciences
Rhuematologic Research Center
Kargar Ave,Shariati Hospital
Tehran ,Iran
Country 2249 0
Iran, Islamic Republic Of
Phone 2249 0
0098-912-1259701
Fax 2249 0
+ 98 21 8802 6956
Email 2249 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.