Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)Phase 3NCT01476774

NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain

A Phase 3 study testing Buprenorphine Transdermal System in people with Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation), run by Mundipharma (China) Pharmaceutical Co. Ltd at 1 site in China.

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

This is a multiple-dose, double-blind, double-dummy, active-control, parallel-group, multi-center, safety and efficacy study. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)
What is being tested?: Buprenorphine Transdermal System
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 280 participants
Where: 1 siteChina
Study dates: Aug 2009to Jun 2010
Phase: Phase 3
Are there results?: None posted in the registry

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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females age are ≥20 ,≤80 years.
Clinical diagnosis of musculoskeletal pain for 4 weeks or longer with non-malignant pain etiology at Visit 1.
Subject is a current user of NSAIDS or paracetamol and reports a history of insufficient therapeutic benefit in musculoskeletal pain.
Subjects must record an 'average pain over the last week at study institution' score at primary pain site of ≥ 4 on an 11-point numerical pain rating scale.
Subjects must be able to understands the study procedures and assessment, and agree to participate in the study by giving written informed consent.

Who cannot join

Subjects who have been taking long-acting or short-acting opioid analgesic formulations within the last 4 weeks.
Subjects who have a current chronic disease(s) or who have a past history and high possibilities to relapse, in addition to their musculoskeletal pain, requiring frequent analgesic therapy.
Subjects with clinically unstable respiratory disease, dysfunction of the biliary tract, thyroid disease, adrenal cortical insufficiency, prostatic hypertrophy requiring intervention or renal artery stenosis.
Subject who have a past history of malignant neoplasm including leukemia and lymphoma.
Subjects with clinically unstable, active or symptomatic heart disease.
Subjects who have psychiatric disorder, uncontrolled seizures or convulsive disorder and so on.

Show all 18Show fewer

Subjects who have a current or past (within 5 years) history of substance or alcohol abuse, or subjects who give a positive result in drug abuse test during the Screening Period.
Subjects scheduled for therapies within the study period which might effect study assessment.
Females who are pregnant, lactating or have a possibility of being pregnant.
Subjects with values > 2 times the upper limit of normal for AST or ALT or total bilirubin at visit 1 or who have severe impaired liver function.
Subjects with serum creatinine > 2 mg/dL at Visit 1 or who have severe impaired renal function.
Subjects with serum potassium < 3.5 mEq/L at Visit 1.
Subjects receiving hypnotics or other central nervous system (CNS) depressants.
Subjects receiving monoamine oxidase inhibitor (MAOI) within 2 weeks before screening.
Subjects who have a history of supersensitivity to study drug.
Known intolerance to and/or lack of effect of tramadol.
Subjects who participated in a clinical research study within 1 month of study entry.
Subjects who participated previously in a BTDS study.

Trial locations and contacts

1 site in 1 country.

China1 site

Investigational Site:Peking Union Medical Hospital (PUMC)
Beijing

Other trials in China

About this study

This is a multiple-dose, double-blind, double-dummy, active-control, parallel-group, multi-center, safety and efficacy study.

Conditions: Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)
Being tested: Buprenorphine Transdermal System
Medical subject headings: Disease

What participants receive

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

Buprenorphine Transdermal SystemDrug
Titration period（21 days）:BTDS 5 mg or oral tramadol CR 100 mg bid, and will then be titrated, if necessary, a maximum of BTDS 20 mg or oral tramadol CR 200 mg bid will be given.
maintenance period(5 week):Patients will continue at a dosage level that provided acceptable pain control .
Buprenorphine Transdermal SystemDrug
Titration period（21 days）:BTDS 5 mg or oral tramadol CR 100 mg bid, and will then be titrated, if necessary, a maximum of BTDS 20 mg or oral tramadol CR 200 mg bid will be given.
maintenance period(5 week):Patients will continue at a dosage level that provided acceptable pain control .

Study groups in NCT01476774
Study group	Role	What they receive
Buprenorphine Transdermal System	Active comparator	Not described Receives: Drug: Buprenorphine Transdermal System
Tramadol CR	Active comparator	Not described Receives: Drug: Buprenorphine Transdermal System

What is being measured

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

The primary Efficacy Variable is the change of Pain Intensity (Patients Visual Analogue Scale) from baseline
Measured: 11 weeks

Timeline

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

Aug 2009Jun 2010

First posted22 Nov 2011 (estimated)
Study startAug 2009
Primary completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)Studies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 280 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01476774
Sponsor's protocol ID: BP08-CN-001
Status last verified: Jul 2015
First submitted: 17 Nov 2011
Last updated: 8 Jul 2015
Results posted: No
Data monitoring committee: No

Publications

Leng X, Li Z, Lv H, Zheng Y, Liu Y, Dai K, Yao C, Yan X, Zeng X. Effectiveness and Safety of Transdermal Buprenorphine Versus Sustained-release Tramadol in Patients With Moderate to Severe Musculoskeletal Pain: An 8-Week, Randomized, Double-Blind, Double-Dummy, Multicenter, Active-controlled, Noninferiority Study. Clin J Pain. 2015 Jul;31(7):612-20. doi: 10.1097/AJP.0000000000000144.
PubMed 25503600

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain
ClinicalTrials.gov ID: NCT01476774
Acronym / sponsor ID: BP08-CN-001
Conditions: Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 280 participants (actual)
Lead sponsor: Mundipharma (China) Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Jun 2010 (actual)
First posted: 22 Nov 2011 (estimated)
Results: Not posted in the source record

Clinical summary

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

This is a multiple-dose, double-blind, double-dummy, active-control, parallel-group, multi-center, safety and efficacy study.

Study design

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

Arm	Type	Receives
Buprenorphine Transdermal System	Active comparator	Drug: Buprenorphine Transdermal System
Tramadol CR	Active comparator	Drug: Buprenorphine Transdermal System

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males or females age are ≥20 ,≤80 years.
Clinical diagnosis of musculoskeletal pain for 4 weeks or longer with non-malignant pain etiology at Visit 1.
Subject is a current user of NSAIDS or paracetamol and reports a history of insufficient therapeutic benefit in musculoskeletal pain.
Subjects must record an 'average pain over the last week at study institution' score at primary pain site of ≥ 4 on an 11-point numerical pain rating scale.
Subjects must be able to understands the study procedures and assessment, and agree to participate in the study by giving written informed consent.

Key exclusion criteria (18 listed)

Subjects who have been taking long-acting or short-acting opioid analgesic formulations within the last 4 weeks.
Subjects who have a current chronic disease(s) or who have a past history and high possibilities to relapse, in addition to their musculoskeletal pain, requiring frequent analgesic therapy.
Subjects with clinically unstable respiratory disease, dysfunction of the biliary tract, thyroid disease, adrenal cortical insufficiency, prostatic hypertrophy requiring intervention or renal artery stenosis.
Subject who have a past history of malignant neoplasm including leukemia and lymphoma.
Subjects with clinically unstable, active or symptomatic heart disease.

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
Buprenorphine Transdermal SystemTitration period（21 days）:BTDS 5 mg or oral tramadol CR 100 mg bid, and will then be titrated, if necessary, a maximum of BTDS 20 mg or oral tramadol CR 200 mg bid will be given. maintenance period(5 week):Patients will continue at a dosage level that provided acceptable pain control .	Drug	Tramadol CR
Buprenorphine Transdermal SystemTitration period（21 days）:BTDS 5 mg or oral tramadol CR 100 mg bid, and will then be titrated, if necessary, a maximum of BTDS 20 mg or oral tramadol CR 200 mg bid will be given. maintenance period(5 week):Patients will continue at a dosage level that provided acceptable pain control .	Drug	Buprenorphine Transdermal System

Primary outcome

The primary Efficacy Variable is the change of Pain Intensity (Patients Visual Analogue Scale) from baseline
Time frame: 11 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
Derived from this study: PubMed 25503600Leng X, Li Z, Lv H, Zheng Y, Liu Y, Dai K, Yao C, Yan X, Zeng X. Effectiveness and Safety of Transdermal Buprenorphine Versus Sustained-release Tramadol in Patients With Moderate to Severe Musculoskeletal Pain: An 8-Week, Randomized, Double-Blind, Double-Dummy, Multicenter, Active-controlled, Noninferiority Study. Clin J Pain. 2015 Jul;31(7):612-20. doi: 10.1097/AJP.0000000000000144.

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.

Mundipharma China Ltd. study chair

Mundipharma China Ltd.

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

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 18 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 8 Jul 2015. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The primary Efficacy Variable is the change of Pain Intensity (Patients Visual Analogue Scale) from baseline (time frame: 11 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 NCT01476774, which also lists 1 linked publication.

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 8 Jul 2015.