PainPhase 3NCT00713817

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

A Phase 3 study testing Sativex® in people with Pain and Peripheral Neuropathy, run by Jazz Pharmaceuticals at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Peripheral Neuropathy
What is being tested?: Sativex®
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 19 participants
Where: 1 siteUnited Kingdom
Study dates: Mar 2007to Jul 2007
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Pain Management Research, Clinical Trials Unit, Netherwood House, Solihull Hospital
Solihull, West Midlands, B91 2JL,

Other trials in United Kingdom

About this study

Official title: 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

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

Read the detailed description

A five week randomised-withdrawal phase (Part B) for a subset of subjects who took part in a 38 week, multicentre, open label (Part A) follow-on study to evaluate, the maintenance of effect of, the development of tolerance through exposure to, and safety of, Sativex® in the treatment of subjects with neuropathic pain. Subjects returned to the centre for an end of treatment visit at week 38 of Part A (Visit 5, Day 266), followed by Visits 5b (week 39), 5c (week 43) and an end of study visit took place 28 days after Visit 5c or withdrawal from the study.

Conditions: Pain, Peripheral Neuropathy
Being tested: Sativex®, Placebo
Keywords: Pain, Peripheral Neuropathy
Medical subject headings: Pain, Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sativex®Drug
Also called GW-1000-02
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
PlaceboDrug
Also called GW-4001-01
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

Study groups in NCT00713817
Study group	Role	What they receive
Sativex	Experimental	Not described Receives: Drug: Sativex®
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 0-35

Secondary outcomes (6)

Change From Baseline Neuropathic Pain Score at the End of Treatment
The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.
Measured: Day 7 to 35
Number of Subjects Who Failed Treatment at the End of the Treatment Period
Treatment failure was defined as follows:
1. Premature termination of Part B (Randomised-Withdrawal) study medication. All subjects who did not complete at least 28 days on Part B (Randomised-Withdrawal) study medicationOr:
2. An increase in pain, i.e. the mean pain 0-10 Numerical Rating Scale over seven consecutive days after Part B (Randomised-Withdrawal) randomisation had increased by at least 20% from the Part B (Randomised-Withdrawal) randomised treatment baseline.
Measured: Day 7 to time of last dose
Number of Subjects With More Than a 20% Loss of Response at the End of Treatment
The percentage change from baseline in mean 0-10 Numerical Rating Scale pain score was calculated. The percentage changes from baseline were classified and the number of subjects with 20% or greater loss of response to treatment (i.e. percent increase from baseline ≥ 20%) is presented.
Measured: 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)
The sleep disruption Numerical Rating Scale was completed 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 how your pain disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.
Measured: Day 0-35
Subject Global Impression of Change at the End of Treatment
A 7-point Likert-type scale was used, with the question: 'Please assess the status of your nerve pain since entry into the study using the scale below' with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". The number of subjects wo reported an improvement is presented.
Measured: Day 7 to 35
Incidence of Adverse Events as a Measure of Subject Safety
The number of subjects who experienced an adverse event during the course of the study is presented.
Measured: Day 0 -35

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Jul 2007

First posted11 Jul 2008 (estimated)
Study startMar 2007
Primary completionJul 2007
Study completionJul 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00713817
Sponsor's protocol ID: GWCL0404 Part B
Status last verified: Apr 2023
First submitted: 10 Jul 2008
Last updated: 3 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00713817
Acronym / sponsor ID: GWCL0404 Part B
Conditions: Pain, Peripheral Neuropathy
Keywords: Pain, Peripheral Neuropathy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Jul 2007 (actual)
Study completion: Jul 2007 (actual)
First posted: 11 Jul 2008 (estimated)
Results: Posted 16 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sativex	Experimental	Drug: Sativex®
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sativex®Also: GW-1000-02Containing 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	Drug	Sativex
PlaceboAlso: GW-4001-01containing 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	Drug	Placebo

Primary outcome

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)
Time frame: Day 0-35
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.

6 secondary outcomes

Change From Baseline Neuropathic Pain Score at the End of Treatment
Time frame: Day 7 to 35
Number of Subjects Who Failed Treatment at the End of the Treatment Period
Time frame: Day 7 to time of last dose
Number of Subjects With More Than a 20% Loss of Response at the End of Treatment
Time frame: 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)
Time frame: Day 0-35
Subject Global Impression of Change at the End of Treatment
Time frame: Day 7 to 35
Incidence of Adverse Events as a Measure of Subject Safety
Time frame: Day 0 -35

Results and safety

Results posted to the registry on 16 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sativex	10	10
Placebo	9	9

Primary outcome: 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)

Time frame: Day 0-35. Mean (Standard Deviation). Unit: units on a scale

Measure	Sativex n = 10	Placebo n = 9
Value	0.57 (1.06)	-0.49 (2.32)

Sativex vs Placebo: Estimated mean treatment difference: 0.89 (95% CI -0.78 to 2.56), p = 0.273, ANCOVA

Population analysed: The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events (AEs) occurring from the time of consent to post study follow up (63 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sativex	0 of 10 (0%)	3 of 10 (30%)	Not reported
Placebo	0 of 9 (0%)	2 of 9 (22.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Barbara Hoggart, MBBS, FRCA principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sativex® in people with Pain and Peripheral Neuropathy, run by Jazz Pharmaceuticals at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Day 0-35). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00713817.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.