FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2011/12/002207 [Registered on: 05/12/2011] Trial Registered Retrospectively
Last Modified On: 30/11/2011
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Study in Pain 
Scientific Title of Study   Single Center, Open-Label, Prospective Study for Evaluation of Dosulepin Hydrochloride in the Management of Chronic Pain. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
A12:837  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Devanathan Vasudevan 
Designation  Principal Investigator 
Affiliation  THE BRAIN, SPINE & NERVE CENTRE, 
Address  THE BRAIN, SPINE & NERVE CENTRE, No. 72, 1st Main Road, West CIT Nagar, T. Nagar, Chennai.
same as mentioned
Chennai
TAMIL NADU
600035
India 
Phone  9962576681  
Fax  914424741686  
Email  drvasu64@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Devanathan Vasudevan 
Designation  Principal Investigator 
Affiliation  THE BRAIN, SPINE & NERVE CENTRE, 
Address  THE BRAIN, SPINE & NERVE CENTRE, No. 72, 1st Main Road, West CIT Nagar, T. Nagar, Chennai.
same as mentioned
Chennai
TAMIL NADU
600035
India 
Phone  9962576681  
Fax  914424741686  
Email  drvasu64@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Devanathan Vasudevan 
Designation  Principal Investigator 
Affiliation  THE BRAIN, SPINE & NERVE CENTRE, 
Address  THE BRAIN, SPINE & NERVE CENTRE, No. 72, 1st Main Road, West CIT Nagar, T. Nagar, Chennai.
same as mentioned
Chennai
TAMIL NADU
600035
India 
Phone  9962576681  
Fax  914424741686  
Email  drvasu64@gmail.com  
 
Source of Monetary or Material Support  
Abbott India Limited 
 
Primary Sponsor  
Name  Abbott India Limited 
Address  Abbott India Limited 3-4, Corporate Park, Sion - Trombay Road, Mumbai - 400 071. India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vasudevan  THE BRAIN, SPINE & NERVE CENTRE  Neurology Department, No. 72, 1st Main Road, West CIT Nagar, T. Nagar
Chennai
TAMIL NADU 		 919962576681
914424741686
drvasu64@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Alert Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dosulepin Hydrochloride  Tablet - 75 mg, Once in a day,Route - Oral 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult male and female patients aged 18-65 years, suffering from non-neoplastic chronic pain persisting for more than three months. 
 
ExclusionCriteria 
Details  Main Exclusion Criteria:
1. Patients with a history of acute chest pain or myocardial infarction in the previous 3 months. Patients with cardiac conduction defects or disorders of cardiac rhythms.
2. Patients with history of severe pulmonary disease with symptoms of severe breathlessness at rest, chronic cough or wheezing.
3. Patients with severe liver disease (Liver function tests ¡Ý 3 times the upper limit of normal) or history of acute abdominal pain, colicky gastrointestinal pain in the last 3 months.
4. Patients with a history of prostatic hypertrophy or those undergoing elective surgery.
5. Patients with history of epilepsy, dementia, or encephalopathy.
6. Patients with a history of narrow angle glaucoma and/or disturbances in visual acuity.
7. Patients with a history of substance abuse or an allergic reaction to an opioid or a TCA.
8. Patients with a history of mania or suicidal tendencies.
9. Patients being treated with thyroid hormone or those suffering from hyperthyroidism.
10. Pregnant or lactating women and female patients not willing to use adequate birth control measures, from the time of screening until the completion of the study.
11. Patients on MAO inhibitors, barbiturates, local anesthetics containing adrenaline (epinephrine) or noradrenaline (norepinephrine), quinidine, SSRIs, CNS depressants, anaesthetic drugs, drugs which affect cardiac conduction, methylphenidate and who cannot be withdrawn, will be excluded.(Refer Appendix C for complete list).
12. Patients with history of hypersensitivity to Dosulepin or any of its ingredients.
13. Subjects who have used any investigational product within 30 days prior to the screening visit.
These exclusion criteria are adequate to identify and exclude patients of chronic pain who may be harmed if included in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary objective of the study is to show that there will be change in pain score from baseline till end of therapy at three months evaluated by a 11 point Numerical Rating Scale (NRS). This is tested using a two sided paired t-test where the 11 point NRS values are measured at baseline and the end of the study (or the last value measured score). A 95% confidence interval for mean change in 11 point NRS scores pre and post treatment will be calculated.  Three Months 
 
Secondary Outcome  
Outcome  TimePoints 
Analysis of Secondary Endpoints:
1. Quality of life assessed by change in score from baseline of American Chronic Pain Association-Quality of Life Questionnaire
2. Improvement in daily living assessed by change in score from baseline in Outcome related to impact on daily living (ORIDL).
3. Improvement in sleep will be assessed by change in score from baseline in Verran and Snyder-Halpern (VSH) scale.
 		 06 Months 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   22/06/2011 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   yet to finalize 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Chronic pain is a major public health problem that places serious stress on afflicted individuals, the health care system and private industry. It has been associated with deficits in quality of life and psychological adjustment, disability, reduced income potential, high levels of health care utilization and high costs to private industry. International Association for the Study of Pain1 defines Chronic Pain as pain without apparent biological value that has persisted beyond the normal tissue healing time (usually taken to be 3 months). Chronic pain affects individuals of all ages and ethnic backgrounds as well as both sexes.

The most common causes of Chronic Pain  include but are not limited to backache headaches and migraines, cancer, degenerative conditions, trigeminal neuralgia, fibromyalgia.

The type of chronic pain include:

Mild to severe pain that does not go away

Pain that may be described as shooting, burning, aching, or electrical

Feeling of discomfort, soreness, tightness, or stiffness

 More often, pain is not a symptom that exists alone. Other problems associated with pain include:

Fatigue

Sleeplessness

Withdrawal from activity and increased need to rest

Weakened immune system

Changes in mood including hopelessness, fear, depression, irritability, anxiety, and stress

Disability

CHRONIC PAIN prevalence estimates reported in various international studies range from 10.1% to 55.2%.  
Close