PainPhase 3NCT02831569

Japanese IP-TN Trial

A Phase 3 study testing Loxoprofen sodium and Methocarbamol in people with Pain, run by Boehringer Ingelheim at 3 sites in Japan.

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 an open-label, single-group, multi-centre trial to confirm the safety and efficacy of loxoprofen sodium/methocarbamol ( IP-TN) when administered orally for 2 weeks to patients with low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome associated with muscle strain. Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Pain
What is being tested?: Loxoprofen sodium and Methocarbamol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 3 sitesJapan
Study dates: 27 Jul 2016to 19 Oct 2016
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 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female outpatients aged >=15 years at the time of giving consent.
Patients diagnosed with low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome prior to giving consent. Patients with cervico-omo-brachial syndrome must have the associated symptom of occipital pain.
No medical therapy for the target disease (low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome) for more than one week prior to Visit 1 (start day of treatment).
Patients who meet following criteria with examination conducted before the start of treatment at Visit 1(start day of treatment)
Based on patient interview, the evaluation site (low back, shoulder or neck) decided by investigator and visual analogue scales score of >=40 mm (in case there are some evaluation sites, investigators determine its evaluation sites to one site with the biggest of visual analogue scale score.
Visual analogue scales score of >=40 mm in one of pain symptoms (tenderness, listlessness, pain at rest, pain on motion, night-time pain, or limitation of motion) prior to the start of treatment.

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Muscle strain at the evaluation site (low back, shoulder or neck) has been diagnosed by the Investigator based on patient interview and palpation.
Patients with pain symptoms at Visit 1 (start day of treatment) who are, in the Investigator's opinion, suitable for treatment with NSAIDs and muscle relaxants.
Signed and dated written informed consent in accordance with Good Clinical Practice and local legislation prior to admission to the trial. For minors (aged >=15 to <20 years), written informed consent must also be obtained from their legal representative.

Who cannot join

Bronchial asthma at the time of giving consent For patients with allergic rhinitis or atopic disease, the absence of bronchial asthma must be confirmed and documented in the source data.
Treatment for oesophageal, gastric or duodenal ulcer or erosion within 4 weeks prior to giving consent
At Visit 1 (start day of treatment), patients with symptoms at the evaluation site due to injury, tumour, infection or rheumatoid arthritis, or those with obvious neurological (radicular) symptoms (e.g., hernia, etc.) or who may require surgery during the trial period
At Visit 1 (start day of treatment), cervical sprain (whiplash)
Patients who must carry out hazardous works such as working at high places or driving a car during the trial or those who are, in the Investigator's opinion, difficult to comply with the protocol.
Patients with cervico-omo-brachial syndrome whose headache is clearly different from the associated symptom of occipital pain or is indistinguishable from occipital pain

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Patients on therapy for the target disease of this trial (low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome) at the time of giving consent or those having a plan to start a new therapy in the future. The therapy includes medical therapy, physical therapy and rehabilitation.
Using corticosteroids (oral, injection or suppository or topical use for pain relief) within 4 weeks prior to Visit 1 (start day of treatment)
-- The use of inhaled corticosteroids for asthma and chronic obstructive pulmonary disease is allowed.
Patients who must use the prohibited medications or treatments during the trial period
Past or present alcohol or drug abuse
Past or present other clinically significant comorbidities (serious cardiac, renal, hepatic or haematologic disorders, psychiatric disorders, aspirin asthma, etc.) in the Investigator's judgment
Any documented or suspected allergy or hypersensitivity to the individual active ingredients of the trial medication, analgesics, NSAIDs, sulfa, cyclooxygenase inhibitors or lactose
Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix
Premenopausal women (within 1 year since the last menstruation prior to giving consent) who are:
lactating or pregnant
having childbearing potential but not practicing adequate contraception or having no plan to use contraception continuously during the trial and refusing to take periodic pregnancy tests during the trial. Adequate contraceptive methods include tubal ligation, intrauterine device, oral contraceptive, complete abstinence, double-barrier methods and male partner's vasectomy.
Receiving any investigational product within 4 weeks prior to Visit 1 (start day of treatment) or having a plan to receive other investigational product during the trial.
Patients who are inappropriate as the subjects of this trial in the Investigator's opinion

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Fukuwa Clinic
Tokyo, Chuo-ku, 103-0027
Tokyo-Eki Center-building Clinic
Tokyo, Chuo-ku, 103-0027
Shinjuku Res. Park Clinic, Tokyo, I.M.
Tokyo, Shinjyuku-ku, 169-0073

Other trials in Japan

About this study

Official title: Open-label, Single-group, Multicentre, Phase III Study to Confirm the Efficacy and Safety of IP-TN When Administered for 2 Weeks to Patients With Low Back Pain, Scapulohumeral Periarthritis, or Cervico-omo-brachial Syndrome Associated With Muscle Strain

After giving written informed consent, patients will be enrolled in the trial. Patients who are considered eligible for the trial by the Investigator after consent and complete the trial procedures and assessments at Visit 1 will receive the trial medication and enter the open-label treatment period of 2 weeks. Patients who complete the open-label treatment period will enter the follow-up period of 1 week and complete the trial after confirmation at the last visit (or phone interview).

Conditions: Pain
Being tested: Loxoprofen sodium, Methocarbamol
Medical subject headings: Pain

What participants receive

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

Loxoprofen sodiumDrug
MethocarbamolDrug

Study groups in NCT02831569
Study group	Role	What they receive
Loxoprofen sodium/methocarbamol FDC	Experimental	fixed dose combination (FDC) tablets Receives: Drug: Loxoprofen sodium; Drug: Methocarbamol

What is being measured

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

Percentage of Patients With Drug-related Adverse Events [AEs]
The outcome measure presents percentage of patients with drug-related AEs.
Measured: Up to 3 weeks.

Secondary outcomes (1)

Assessment of Pain Due to Low Back Pain, Scapulohumeral Periarthritis or Cervico-omo-brachial Syndrome After 2 Weeks of Treatment
The outcome measure presents percentage of patients who showed "marked improvement" or "moderate improvement" in low back pain and/or scapulohumeral periarthritis and/or cervico-omo-brachial syndrome after 2 weeks of treatment.
Measured: Post 2 weeks.

Timeline

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

27 Jul 201619 Oct 2016

First posted13 Jul 2016 (estimated)
Study start27 Jul 2016
Primary completion19 Oct 2016
Study completion19 Oct 2016

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 Boehringer IngelheimThe 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02831569
Sponsor's protocol ID: 1387.1
Status last verified: Oct 2017
First submitted: 11 Jul 2016
Last updated: 20 Jul 2018
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Single-group, Multicentre, Phase III Study to Confirm the Efficacy and Safety of IP-TN When Administered for 2 Weeks to Patients With Low Back Pain, Scapulohumeral Periarthritis, or Cervico-omo-brachial Syndrome Associated With Muscle Strain
ClinicalTrials.gov ID: NCT02831569
Acronym / sponsor ID: 1387.1
Conditions: Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: SSP Co., Ltd.
Study start: 27 Jul 2016 (actual)
Primary completion: 19 Oct 2016 (actual)
Study completion: 19 Oct 2016 (actual)
First posted: 13 Jul 2016 (estimated)
Results: Posted 20 Jul 2018

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Loxoprofen sodium/methocarbamol FDC	Experimental	Drug: Loxoprofen sodium, Drug: Methocarbamolfixed dose combination (FDC) tablets

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Male or female outpatients aged >=15 years at the time of giving consent.
Patients diagnosed with low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome prior to giving consent. Patients with cervico-omo-brachial syndrome must have the associated symptom of occipital pain.
No medical therapy for the target disease (low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome) for more than one week prior to Visit 1 (start day of treatment).
Patients who meet following criteria with examination conducted before the start of treatment at Visit 1(start day of treatment)
Patients with pain symptoms at Visit 1 (start day of treatment) who are, in the Investigator's opinion, suitable for treatment with NSAIDs and muscle relaxants.

Key exclusion criteria (19 listed)

Bronchial asthma at the time of giving consent For patients with allergic rhinitis or atopic disease, the absence of bronchial asthma must be confirmed and documented in the source data.
Treatment for oesophageal, gastric or duodenal ulcer or erosion within 4 weeks prior to giving consent
At Visit 1 (start day of treatment), patients with symptoms at the evaluation site due to injury, tumour, infection or rheumatoid arthritis, or those with obvious neurological (radicular) symptoms (e.g., hernia, etc.) or who may require surgery during the trial period
At Visit 1 (start day of treatment), cervical sprain (whiplash)
Patients who must carry out hazardous works such as working at high places or driving a car during the trial or those who are, in the Investigator's opinion, difficult to comply with the protocol.

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
Loxoprofen sodium	Drug	Loxoprofen sodium/methocarbamol FDC
Methocarbamol	Drug	Loxoprofen sodium/methocarbamol FDC

Primary outcome

Percentage of Patients With Drug-related Adverse Events [AEs]
Time frame: Up to 3 weeks.
The outcome measure presents percentage of patients with drug-related AEs.

1 secondary outcome

Assessment of Pain Due to Low Back Pain, Scapulohumeral Periarthritis or Cervico-omo-brachial Syndrome After 2 Weeks of Treatment
Time frame: Post 2 weeks.

Results and safety

Results posted to the registry on 20 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Loxoprofen Sodium/Methocarbamol [FDC]	80	80

Primary outcome: Percentage of Patients With Drug-related Adverse Events [AEs]

Time frame: Up to 3 weeks.. Number. Unit: Percentage of participants

Measure	Loxoprofen Sodium/Methocarbamol [FDC] n = 80
Value	7.5

Population analysed: Treated Set \[TS\]: The analysis set included patients who received at least one dose of the trial medication during the trial period. Safety analysis was performed on TS.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the first drug administration until 21 days after the last drug administration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Loxoprofen Sodium/Methocarbamol [FDC]	0 of 80 (0%)	0 of 80 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Loxoprofen sodium and Methocarbamol in people with Pain, run by Boehringer Ingelheim at 3 sites in Japan.

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 9 inclusion and 19 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 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. 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 20 Jul 2018). 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?

Percentage of Patients With Drug-related Adverse Events [AEs] (time frame: Up to 3 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 NCT02831569.

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 20 Jul 2018.