A Study of Sativex® for Pain Relief Due to Diabetic Neuropathy

NCT ID: NCT00710424

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 297 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2006-06-30

Brief Summary

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving pain due to Diabetic Neuropathy.

Detailed Description

This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex in subjects with pain due to diabetic neuropathy. Subjects were screened to determine eligibility and completed a seven-day baseline period. Subjects then returned to the centre for assessment, randomisation and dose introduction. Visits occurred at the end of weeks two, six, ten and at the end of the study (treatment week 14) or earlier if they withdrew. A follow up visit occurred 28 days after completion or withdrawal. Subjects in this study were given the opportunity to be enrolled in an open label extension study.

Conditions

Pain; Diabetic Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Sativex

Group Type: EXPERIMENTAL

Sativex

Intervention Type: DRUG

containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.

Interventions

Sativex

containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours

Intervention Type: DRUG

Placebo

containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.

Intervention Type: DRUG

Other Intervention Names

GW-1000-02; GW-4001-01

Eligibility Criteria

Inclusion Criteria

• Willing and able to give informed consent.
• Male or female, aged 18 years or above.
• Ability (in the investigators opinion) and willingness to comply with all study requirements.
• Diagnosed with Type 1 or 2 diabetes mellitus as diagnosed according to the World Health Organisation (WHO) criteria.
• Diagnosed with neuropathic pain due to distal symmetrical diabetic neuropathy of at least six months duration, as defined by a NDS score of at least 4, and in who pain is not wholly relieved with their current therapy. The NDS score must be attained from at least two different test parameters and not only the ankle jerk reflex.
• The last six daily diary 0-10 NRS pain scores before randomisation summed to at least 24.
• Stable dose of regular pain medication and non-pharmacological therapies (including TENS) for at least 14 days prior to the screening visit and willingness for these to be maintained throughout the study.
• Agreement for the responsible authorities (as applicable in individual countries), their primary care physician, and their consultant, if appropriate, to be notified of their participation in the study.

Exclusion Criteria

• Concomitant pain thought by the investigator to be of a nature or severity to interfere with their assessment of their painful diabetic neuropathy.
• Uncontrolled diabetes with HbA1c blood levels of more than 11% at Visit1, Day B1.
• Receiving a prohibited medication and were unwilling to stop or comply for the duration of the study.
• Has used cannabinoid based medications within 60 days of study entry and were unwilling to abstain for the duration for the study.
• Has used cannabis within 30 days of study entry and were unwilling to abstain for the duration for the study.
• History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
• Known or suspected history of alcohol or substance abuse.
• History of epilepsy or recurrent seizures.
• Known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP.
• Postural drop of 20mmHg or more in systolic blood pressure at screening.
• Medical history of gastroparesis.
• Evidence of cardiomyopathy.
• Experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction.
• QT interval; of > 450 ms (males) or > 470 ms (females) at Visit 1.
• Secondary or tertiary AV block or sinus bradycardia (HR <50bpm) or sinus tachycardia (HR>110bpm) at Visit 1.
• Diastolic blood pressure of <50 mmHg or >105 mmHg in a sitting position at rest for five minutes prior to randomisation.
• Impaired renal function i.e., creatinine clearance is lower than 50 ml/min at Visit 1.
• Significantly impaired hepatic function, at Visit 1, in the investigator's opinion.
• Female subjects of child bearing potential and male subjects whose partner was of child bearing potential, unless they were willing to ensure that they or their partner used effective contraception during the study and for three months thereafter.
• If female, were pregnant or lactating, or were planning pregnancy during the course of the study and for three months thereafter.
• Received an IMP within the 12 weeks before Visit 1.
• Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study, or the subject's ability to participate in the study.
• Following a physical exam, the subject had any abnormalities that, in the opinion of the investigator, would prevent the subject from safely participating in the study.
• Intention to donate blood during the study.
• Intention to travel internationally during the study.
• Previous randomisation into this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Solomon Tesfaye, JCHMT FRCP

Role: PRINCIPAL_INVESTIGATOR

Royal Hallamshire Hospital

Locations

Royal Hallamshire Hospital

Sheffield, Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

GWCL0305

Identifier Type: -

Identifier Source: org_study_id