Clinical trial

A Multicentre, Open Label, Follow on Study to Assess the Maintenance of Effect, Tolerance and Safety of Sativex® in the Treatment of Subjects With Neuropathic Pain. This Will be Followed by a Randomised-withdrawal Phase (Part B) for a Subset of Patients

Name

GWCL0404 Part B

Description

The purpose of this study is to assess the maintenance of effect after long-term treatment of Sativex® in subjects with neuropathic pain.

Trial arms

Trial start

2007-03-01

Estimated PCD

2007-07-01

Trial end

2007-07-01

Status

Completed

Phase

Early phase I

Treatment

Sativex®

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

Arms:

Sativex

Other names:

GW-1000-02

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

Arms:

Placebo

Other names:

GW-4001-01

Size

Primary endpoint

Change From Baseline in Mean Daily Pain Severity on a 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)

Day 0-35

Eligibility criteria

Inclusion Criteria: * Had participated in GWCL0404, was currently ongoing in the study (i.e. still receiving GW-1000-02 treatment) and had completed the study up to Visit 5 * Had complied with all of the study requirements to-date, including the completion of the diary cards * Had shown tolerability to the study medication in this study * Ability (in the investigators opinion) and willingness to comply with all study requirements, including the completion of diary cards and study questionnaires Exclusion Criteria: * Had experienced or was currently experiencing any adverse events or untoward medical occurrences which, in the opinion of the investigator, would prevent them from safely participating in this phase of the study

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}

Updated at

2023-05-03

1 organization

2 products

2 indications

Product

Indication

Indication

Product

Organization