Chronic Pain Patients who do not respond to Codeine due to their genetic profile

Phase 1

• Conditions: Chronic pain; Therapeutic area: Body processes [G] - Genetic Phenomena [G05]

• Registration Number: EUCTR2007-006184-70-GB
• Lead Sponsor: The Leeds Teaching Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

I.Male or female Caucasian subjects, ages between 18-80 years.

II.Signed and dated written informed consent.

III.Females of childbearing potential must have a negative pregnancy test and be practicing an effective form of contraception.

IV.Patients with a chronic pain condition >3 months duration that has been diagnosed by a pain management specialist.

V.Patients with moderate to severe chronic pain (defined as a score of 4 (out of 10) or above on worst pain in the last 24 hours (question 3) on the Brief Pain Inventory at screening and daily in the Patient Diary during pre-treatment.)

VI.Adequate renal function (serum creatinine females <130 ?mol/l: males <150 ?mol/l).

VII.Liver enzymes (AST or ALT) less than twice the upper limit of normal. Alkaline phosphates less than twice the upper limit of normal.

VIII.Bilirubin within the normal range, or abnormalities clinically insignificant in the judgment of the investigator.

IX.Deemed capable of complying with study schedule, procedures and medications

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

I.Patients with a known sensitivity to codeine or who have a history of experiencing intolerable opioid analgesic side effects.

II.Patients whose pain could be adequately controlled by increasing their dose of weak opioids.

III.Patients with a history of recreational drug use within the last 2 years.

IV.Patients with a history of alcohol abuse within the last 2 years.

V.Female patients who are pregnant, lactating or of child bearing potential who are not taking adequate contraceptive precautions i.e. an oral contraceptive, an approved hormonal implant, an intrauterine device or condoms/diaphragm and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).

VI.Abnormal serum electrolytes, which in the investigators opinion would exclude the patient from this study

VII.Abnormal urine analysis, which in the investigators opinion would exclude the patient from this study

VIII.Haemoglobin outside the normal limits and white blood cell count below the lower limit of normal or above 12 x 109/l.

IX.Concurrent surgery, radiotherapy, chemotherapy or nerve blocks and those who have received this treatment 4 weeks prior to the study.

X.Patients taking drugs known to be inhibitors of the cytochrome P450 isozyme 2D6 (Appendix 17.4).

XI.Patients taking medications that would interfere with the urinalysis e.g. morphine, hydromorphone.

XII.Patients who have anxiety or the depression of a degree that the investigators judge that participation in the study would be detrimental to their mental health.

XIII.Patients who are unable to understand and complete assessment questionnaires in English.

XIV.Patients who have been in another clinical study within the last 4 weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified