Study in Pai

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 63

Inclusion Criteria

Adult male and female patients aged 18-65 years, suffering from non-neoplastic chronic pain persisting for more than three months.

Exclusion Criteria

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SSRIs, CNS depressants, anaesthetic drugs, drugs which affect cardiac conduction, methylphenidate and who cannot be withdrawn, will be excluded.(Refer Appendix C for complete list).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.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.Timepoint: Three Months

Secondary Outcome Measures

Name	Time	Method
Analysis of Secondary Endpoints: <br/ ><br>1.Quality of life assessed by change in score from baseline of American Chronic Pain Association-Quality of Life Questionnaire <br/ ><br>2.Improvement in daily living assessed by change in score from baseline in Outcome related to impact on daily living (ORIDL). <br/ ><br>3.Improvement in sleep will be assessed by change in score from baseline in Verran and Snyder-Halpern (VSH) scale. <br/ ><br>Timepoint: 06 Months