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Trial registered on ANZCTR


Registration number
ACTRN12610000603011
Ethics application status
Approved
Date submitted
22/07/2010
Date registered
26/07/2010
Date last updated
25/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A Double-blind, Randomised, Placebo-controlled, Flexible-dose of 50 mg/day to 400 mg/day, Phase IIIb Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel XR) as an Add-on Therapy in Patients with Chronic Somatoform Pain Disorder
Scientific title
A Double-blind, Randomised, Placebo-controlled, Flexible-dose of 50 mg/day to 400 mg/day, Phase IIIb Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel XR) as an Add-on Therapy in Patients with Chronic Somatoform Pain Disorder
Secondary ID [1] 252273 0
N/A
Universal Trial Number (UTN)
U1111-1116-1782
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Somatoform Pain Disorder 257796 0
Condition category
Condition code
Mental Health 257968 257968 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
50mg and/or 200mg tablets of Quetiapine Fumarate XR, given at a flexible dose of 50mg up to 400mg oral tablets once a day (as determined by the physician) for a total of 12 weeks, followed by a 1 to 2 week tapering down period.
Flexible dosage of Quetiapine Fumarate XR will be added as an adjunctive therapy to the current pain treatment of patients with Chronic Somatoform Pain Disorder (CSPD). The pain management medications will include non-opioid analgesic/s and/or nonsteroidal anti-inflammatory drugs (NSAIDs), with or without an antidepressant. The dosage amounts and frequency of the patient’s pain treatment medications will differ on a case by case basis.
To be eligible, patients will require: (i) to have been on stable doses of non-opioid analgesic/s and/or nonsteroidal anti-inflammatory drugs (NSAIDs), with or without an antidepressant for at least 6 weeks; and (ii) to have experienced an inadequate response.
Intervention code [1] 256858 0
Treatment: Drugs
Comparator / control treatment
Placebo as matching 50mg and 200mg tablets only without the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 258833 0
Pain intensity with 33% decrease of numerical rating scale for pain (NRS-P) score.
Timepoint [1] 258833 0
At baseline and at 1, 2, 3, 4, 6, 8, 12 weeks after intervention commencement.
Secondary outcome [1] 264945 0
Short-form McGill Pain Questionnaire (SF-MPQ)
Timepoint [1] 264945 0
At baseline and at 1, 2, 3, 4, 6, 8, 12 weeks after intervention commencement.
Secondary outcome [2] 264946 0
Substance P (SP) is a neuropeptide shown to be a possible biological marker of chronic pain, and has been found to be significantly decreased in the saliva of chronic pain patients as compared with that of healthy human volunteers. Samples of saliva will be collected using a saliva collection device and transferred frozen on dry ice to Southern Cross Pathology Australia, where the samples will be stored at < 80oC until ready to be analysed using a Substance P Immunoassay. Saliva levels of SP will be measured and analysed to determine if a significant change has occurred during the course of the study. A significant increase in saliva levels SP from randomisation to Visit 9 indicates a reduction in pain perception.
Timepoint [2] 264946 0
At baseline and at 6 and 12 weeks after intervention commencement.

Eligibility
Key inclusion criteria
1. Provision of written and informed consent prior to initiating any study related procedures.
2. Male and female aged 18 to 65 years, inclusive.
3. Documented clinical diagnosis meeting criteria from the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) for 307.89 Chronic (Somatoform) Pain Disorder associated with both Psychological Factors and General Medical Condition.
4. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (hCG) pregnancy test at enrolment.
5. Patients who have been on stable doses of non-opioid analgesic/s, Non-steroidal anti-inflammatory drugs (NSAIDs) with/or without an antidepressant (excluding fluvoxamine), for at least 6 weeks.
6. Be able to understand and comply with the requirements of the study, as judged by the investigator.
7. Clinical diagnosis of one or more of the following spine structure problems: facet joints, spinal stenosis, paraspinal muscles, sacroiliac joint, spondylolysis/spondylolisthesis, nonspecific back pain and diskogenic.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current or past history of: manic, hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV-TR).
2. Presence or history of a clinically significant neurological disorder (Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, Huntington’s disease, epilepsy etc.).
3. Pregnancy or lactation.
4. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
5. Known intolerance or lack of response to quetiapine fumarate as judged by the investigator.
6. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir.
7. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids .
8. Administration of a depot antipsychotic injection within two dosing interval before randomisation.
9. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria.
10. Medical conditions that would affect absorption, and metabolism, or excretion of study medication (e.g., malabsorption syndrome, liver disease).
11. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator.
12. Involvement in the planning and conduct of the study.
13. Previous enrolment or randomisation of treatment in the present study.
14. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements.
15. A patient with diabetes mellitus (DM) fulfilling one of the following criteria:
Unstable DM defined as enrolment glycosylated haemoglobin (HbA1c) > 8.5%;
Admitted to hospital for treatment of DM or DM related illness in past 12 weeks;
Not under physician care for DM;
Physician responsible for patient’s DM care has not indicated that patient’s DM is controlled;
Physician responsible for patient’s DM care has not approved patient’s participation in the study;
Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks; and
Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks.
Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
16. An absolute neutrophil count (ANC) of less than or equal to 1.5 x 109 per litre.

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)
Blinded randomisation schedule has been provided by 'off-site' 3rd party pharmacist responsible for coding the study medication.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
22/08/2011
Actual
29/08/2011
Date of last participant enrolment
Anticipated
22/02/2013
Actual
27/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257322 0
Commercial sector/Industry
Name [1] 257322 0
AstraZeneca Pty Ltd
Country [1] 257322 0
Australia
Primary sponsor type
Individual
Name
Dr Peter Farnbach
Address
Neurotherapy Victoria (NTVIC)
290 Glenferrie Road
Malvern VIC 3144
Country
Australia
Secondary sponsor category [1] 256561 0
None
Name [1] 256561 0
Address [1] 256561 0
Country [1] 256561 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259346 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 259346 0
Ethics committee country [1] 259346 0
Australia
Date submitted for ethics approval [1] 259346 0
02/09/2010
Approval date [1] 259346 0
24/01/2011
Ethics approval number [1] 259346 0
01-20-09-10

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31422 0
Dr Peter Farnbach
Address 31422 0
Neurotherapy Victoria (NTVIC 290 Glenferrie Road Mlavern VIC 3144
Country 31422 0
Australia
Phone 31422 0
+61 3 9822 5033
Fax 31422 0
Email 31422 0
peter@ntvic.com.au
Contact person for public queries
Name 14669 0
Peter Farnbach
Address 14669 0
Neurotherapy Victoria (NTVIC)
290 Glenferrie Road
Malvern VIC 3144
Country 14669 0
Australia
Phone 14669 0
+61 3 9822 5033
Fax 14669 0
+61 3 9822 5055
Email 14669 0
peter@ntvic.com.au
Contact person for scientific queries
Name 5597 0
Peter Farnbach
Address 5597 0
Neurotherapy Victoria (NTVIC)
290 Glenferrie Road
Malvern VIC 3144
Country 5597 0
Australia
Phone 5597 0
+61 3 9822 5033
Fax 5597 0
+61 3 9822 5055
Email 5597 0
peter@ntvic.com.au

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.