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PainPhase 3NCT00713323

A Study to Compare the Safety and Tolerability of Sativex® in Patients 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 safety and tolerability of long term therapy with Sativex® in relieving 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?
No, everyone receives an active treatment
How many people
380 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2005to Jun 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 a GW clinical study to investigate the effects of Sativex® on peripheral neuropathic pain and had completed the study. This must have been within the last seven days
  • Had complied with all of the study requirements in the preceding GW parent RCTs, including the completion of diary cards and study questionnaires
  • Had shown tolerability to the study medication in a preceding GW study
  • Was expected, in the opinion of the investigator, to gain clinical benefit from receiving Sativex® therapy
  • Ability (in the investigators opinion) and willingness to comply with all study requirements, including the completion of diary cards and study questionnaires
  • 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.

Who cannot join

  • 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 study medication 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
Show all 17Show fewer
  • Secondary or tertiary AV block or sinus bradycardia (HR <50bpm unless physiological) 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 measurement at Visit 1
  • Impaired renal function i.e., creatinine clearance is lower than 50ml/min at Visit 1 and is indicative of renal impairment
  • 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 (except the prerequisite study medication from the GW parent RCTs)
  • 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 examination, 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
  • Previous randomisation into this 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 safety and tolerability of long term therapy with Sativex® in relieving neuropathic pain.

Read the detailed description

This was 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. The study provided continued availability of Sativex® to subjects who completed the preceding double-blind neuropathic pain studies. Consenting, eligible subjects who had participated in previous GW Pharma Ltd (GW) randomised, placebo-controlled clinical studies entered the study (Visit 1, Day 0) and commenced dosing. Study visits took place at Week 2 (Visit 2, Day 14), Week 14 (Visit 3, Day 98), and Week 26 (Visit 4, Day 182). Subjects returned to the centre for an end of treatment visit at week 38 (Visit 5, Day 266). All subjects received Sativex®. This was followed by a five week randomised-withdrawal phase (Part B) for a subset of subjects. An end of study visit took place 28 days after Visit 5 (or 5b or 5c) or withdrawal from the study.

Being tested
Sativex®
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%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours

Study groups in NCT00713323
Study groupRoleWhat they receive
SativexExperimentalActive treatment
Receives: Drug: Sativex®

What is being measured

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

  1. Change From Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label Treatment

    The average pain NRS 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 or average pain 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 pain. A negative value indicates an improvement in pain score from baseline.

    Measured: 38 weeks

Secondary outcomes (7)

  1. Change From Parent Study Baseline in Mean Neuropathic Pain Scale (NPS) Score at End of Open-label Treatment (Week 38)

    The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.

    Measured: 38 weeks

  2. Change From Parent Study Baseline in Mean Sleep Quality 0-10 NRS Score at the End of Open-label Treatment (Week 38)

    The sleep disruption NRS 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: 38 weeks

  3. Subject Global Impression of Change

    A 7-point Likert-type scale was used, with the question: 'Please assess the status of your 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". At Visit 2 (Baseline) patients wrote a brief description of their pain which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.

    Measured: week 38

  4. Change From Parent Study Baseline in Mean EuroQol-5D Weighted Health State Index Score at the End of Open-label Treatment

    The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.

    Measured: 38 weeks

  5. Change From Parent Study Baseline in Mean EuroQol-5D Self-rated Health Status Visual Analogue Scale Score at the End of Open-label Treatment

    The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.

    Measured: 38 weeks

  6. Incidence of Adverse Events as a Measure of Subject Safety

    The number of subjects who reported an adverse event during Part A of the study is presented (including the follow-up period of 28 days following cessation of opel-label treatment).

    Measured: 42 weeks

  7. Change From Parent Study Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Open-label Treatment (38 Weeks)

    The patient was asked "on a scale of '0 to 10' please indicate the average level of your intoxication due to medications over the last 24 hours" (0=no intoxication and 10=extreme toxication). A negative value indicates an improvement in pain score from baseline.

    Measured: 38 weeks

Timeline

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

  1. First posted11 Jul 2008 (estimated)
  2. Study startOct 2005
  3. Primary completionJun 2007
  4. Study completionJun 2007

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00713323
Sponsor's protocol ID
GWCL0404 Part A
Status last verified
Apr 2023
First submitted
10 Jul 2008
Last updated
3 May 2023
Data monitoring committee
No

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 6 inclusion and 17 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. 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 14 Sep 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 Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label Treatment (time frame: 38 weeks). 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 NCT00713323.

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.

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