A Study to Determine the Maintenance of Effect After Long-term Treatment of Sativex® in Subjects With Neuropathic Pain

NCT00713817 | Completed Phase 3 Results

• 1 other identifier: GWCL0404 Part B
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Peripheral Neuropathy

Keywords

Pain; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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)

  The pain severity Numerical Rating Scale was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain severity in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of neuropathic pain. A negative value indicates an improvement in pain score from baseline.

  Day 0-35

Secondary Outcomes (6)

• Change From Baseline Neuropathic Pain Score at the End of Treatment

  Day 7 to 35

• Number of Subjects Who Failed Treatment at the End of the Treatment Period

  Day 7 to time of last dose

• Number of Subjects With More Than a 20% Loss of Response at the End of Treatment

  Day 0-35

• Change From Baseline in Sleep Disruption 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)

  Day 0-35

• Subject Global Impression of Change at the End of Treatment

  Day 7 to 35

Study Arms (2)

Sativex

EXPERIMENTAL

Drug: Sativex®

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Sativex® DRUG

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

Also known as: GW-1000-02

Sativex

Placebo 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

Also known as: GW-4001-01

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Pain Management Research, Clinical Trials Unit, Netherwood House, Solihull Hospital

Solihull, West Midlands, B91 2JL,, United Kingdom

Location

MeSH Terms

Conditions

Pain; Peripheral Nervous System Diseases

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Mr Richard Potts, Clinical Operations Director
• Organization: GW Pharma Ltd

rp@gwpharm.com

0044 1223 266800

Study Officials

• Barbara Hoggart, MBBS, FRCA

  Pain Management Research, Clinical Trials Unit, Netherwood House, Solihull Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 11, 2008
• Study Start: March 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: May 3, 2023
• Results First Posted: August 16, 2012

Record last verified: 2023-04

Locations

GB (1)