Neck PainPhase 3NCT02814565
Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin
A Phase 3 study testing Cyclobenzaprine HCl in people with Neck Pain and Back Pain, run by Takeda at 10 sites in Russia.
Trial summary
The purpose of this study was to assess the effect of cyclobenzaprine hydrochloride (HCl) extended release (CER) 15 mg capsule once daily in participants with muscle spasms associated with acute painful musculoskeletal conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- What is being tested?
- Cyclobenzaprine HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 10 sitesRussia
- Study dates
- 12 Oct 2016to 14 Mar 2017
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Is experiencing for no more than 14 days cervical or lower back pain (as assessed by the participant) due to muscle spasms (confirmed by the physician) associated with acute, painful musculoskeletal conditions.
- Is male or female and aged 18 to 50 years, inclusive.
- Female participants require to be either 2 years postmenopausal or surgically sterile by bilateral tubal ligation, hysterectomy, or bilateral oophorectomy, or, if premenopausal, had to be using an approved contraceptive method.
- Female participants of child-bearing potential must have a negative urine human chorionic gonadotropin (hCG) test result for pregnancy at study entry.
- After signing the informed consent form, the participant agrees not to make changes to dietary, exercise, or smoking habits and not to enter a weight loss program during his/her participation in the study.
Who cannot join
- Has muscular pain secondary to acute trauma or fractures (e.g., due to osteoporosis). Such conditions could have been ruled out based on medical history, x-ray, or physical examination.
- Has received any investigational compound within 30 days prior to Screening.
- If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
- Has a history of drug abuse or recent (within the last 12 months) history of excessive alcohol consumption defined as >2 drinks/day (>90 ml of 80 proof alcohol or equivalent).
- Has mild, moderate, severe liver impairment.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
Show all 39Show fewer
- Takes any concomitant medication including over-the-counter and herbal products for muscle spasms. If a participant is taking such medications, the medications has to be discontinued before starting the study.
- Takes or took within last 14 days medications, such as:
- selective serotonin reuptake inhibitors (SSRIs);
- serotonin norepinephrine reuptake inhibitors (SNRIs);
- tricyclic antidepressants (TCAs);
- monoamine oxidase (MAO) inhibitors;
- tramadol;
- bupropion;
- meperidine;
- verapamil;
- non-steroid anti-inflammatory drugs (NSAIDs);
- topical anti-inflammatory medications
- Has a history or clinical manifestations of significant medical condition, such as:
- hyperthyroidism;
- acute recovery phase of myocardial infarction;
- arrhythmias, heart block or conduction disturbances;
- congestive heart failure;
- angle-closure glaucoma;
- urinary retention;
- increased intraocular pressure.
- Has abnormal physical findings or a medical condition that might have placed the participant at risk or interfered with the participant's ability to participate in the study.
- Has any known condition or disorder that might have affected absorption of the study drug.
- Has a history of hypersensitivity or allergies to cyclobenzaprine and/or tricyclic antidepressants or any of their components.
- Has a history of hypersensitivity to any NSAIDs including salicylate sensitivity.
- Has a history of thrombocytopenia.
- Has a history of gastro-intestinal bleeding, cerebrovascular bleeding or other bleeding disorders.
- Had active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
- Has a history of severe renal impairment
- Had a major surgery during the 6 months preceding study entry.
- Has a language barrier or any other problems precluding good communication or cooperation.
- Has any reason to believe that he/she would not be able to complete the evaluations needed in this study.
- Has a known history of positive screen for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
- Drug abuse in anamnesis.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Russia10 sites
Study site
Kazan', Tatarstan Republic
Study site
Lipetsk, Lipetsk Oblast
Study site
Moscow
Study site
Nizhny Novgorod
Study site
Novosibirsk
Study site
Saint Petersburg
Study site
Saransk, Respublika Mordoviya
Study site
Tver'
Study site
Yaroslavl
Study site
Yekaterinburg, Sverdlovsk Oblast
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial to Study the Efficacy and Safety of Cyclobenzaprine HCl Extended Release (CER) 15 mg in Subjects With Acute Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin
The purpose of this study was to assess the effect of cyclobenzaprine hydrochloride (HCl) extended release (CER) 15 mg capsule once daily in participants with muscle spasms associated with acute painful musculoskeletal conditions.
Read the detailed description
The drug being tested in this study was cyclobenzaprine hydrochloride (HCl) extended-release (CER). CER was being tested to treat participants who had muscle spasms associated with acute painful musculoskeletal conditions. This study looked at medication helpfulness, relief from muscle spasms and pain, and improvement in range of motion and daily living activities.
The study enrolled 180 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups which remained undisclosed to the participant and study doctor during the study:
- CER 15 mg
- Placebo (dummy inactive pill) - this was a capsule that looks like the study drug but had no active ingredient
All participants were asked to take one capsule at the same time each day throughout the study.
This multi-center trial was conducted in the Russian Federation. The overall time to participate in this study was up to 45 days. Participants made multiple visits to the clinic, and were contacted by telephone after the last dose of study drug for a follow-up assessment.
- Being tested
- Cyclobenzaprine HCl, Placebo
- Keywords
- Drug therapy
- Medical subject headings
- Neck Pain, Back Pain, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclobenzaprine HClDrug
Also called Myorix®, AMRIX®
Cyclobenzaprine HCl extended-release capsules
PlaceboDrug
Cyclobenzaprine HCl extended release placebo-matching capsules
| Study group | Role | What they receive |
|---|---|---|
| Cyclobenzaprine HCl 15 mg | Experimental | Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days. Receives: Drug: Cyclobenzaprine HCl |
| Placebo | Placebo comparator | Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment
Participants assessed the study medication helpfulness on a daily basis (in the daily diary), using the following 5-point rating scale: "How would you rate this study medication in improving your condition?" "0 = poor", "1 = fair", "2 = good", "3 = very good", "4 = excellent".
Measured: Day 3
Secondary outcomes (9)
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment
Participants assessed the study medication helpfulness on a daily basis (in the daily diary), using the following 5-point rating scale: "How would you rate this study medication in improving your condition?" "0 = poor", "1 = fair", "2 = good", "3 = very good", "4 = excellent".
Measured: Days 7 and 14
Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment
The investigator assessed their clinical global impression of change compared to Baseline, based on physical examination, degree of muscle spasm (presence of muscle spasm assessment), reaction to palpation (presence of local pain assessment), limitation of range of motion, and evaluation of the patient's reported functional assessment (limitation of activities of daily living assessment). The following 5-point rating scale was used: "1 = worse", "2 = no change", "3 = slight improvement", "4 = moderate improvement", "5 = marked improvement".
Measured: Day 3
Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment
The investigator assessed their clinical global impression of change compared to Baseline, based on physical examination, degree of muscle spasm (presence of muscle spasm assessment), reaction to palpation (presence of local pain assessment), limitation of range of motion, and evaluation of the patient's reported functional assessment (limitation of activities of daily living assessment). The following 5-point rating scale was used: "1 = worse", "2 = no change", "3 = slight improvement", "4 = moderate improvement", "5 = marked improvement".
Measured: Days 7 and 15
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Participants assessed their clinical global impression based on relief from local pain, restriction in activities of daily living, restriction of movement and intensity of local pain on a daily basis. The following 5-point rating scale was used: "1 = worse", "2 = no change", "3 = slight improvement", "4 = moderate improvement", "5 = marked improvement".
Measured: Days 3, 7, and 14
Percentage of Responders on Days 3, 7, and 14 of Treatment
A responder was defined as a participant who had both a rating of either "very good" or "excellent" for the participant's rating of medication helpfulness.
Measured: Days 3, 7, and 14
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
The investigator assessment based on physical examination, presence of muscle spasm (presence of muscle spasm assessment). The following 5-point rating scale was used: "1 = none", "2 = mild", "3 = moderate", "4 = moderately severe", "5 = severe".
Measured: Days 3, 7, and 15
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
The investigator assessed local pain based on physical examination, reaction to palpation (presence of local pain assessment). The following 5-point rating scale was used: "1 = none", "2 = mild", "3 = moderate", "4 = moderately severe", "5 = severe".
Measured: Days 3, 7, and 15
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
The investigator assessed limitation of range of motion. The following 5-point rating scale was used: "1 = none", "2 = mild", "3 = moderate", "4 = moderately severe", "5 = severe".
Measured: Days 3, 7, and 15
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
The investigator assessed limitation of activities based on evaluation of the patient's reported functional assessment. The following 5-point rating scale was used: "1 = none", "2 = mild", "3 = moderate", "4 = moderately severe", "5 = severe".
Measured: Days 3, 7, and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start12 Oct 2016
- Primary completion10 Feb 2017
- Study completion14 Mar 2017
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 Neck PainStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814565
- Sponsor's protocol ID
- CYC-RR-001
- Other IDs
- U1111-1162-4846
- Status last verified
- Jan 2019
- First submitted
- 23 Jun 2016
- Last updated
- 8 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial to Study the Efficacy and Safety of Cyclobenzaprine HCl Extended Release (CER) 15 mg in Subjects With Acute Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin
- ClinicalTrials.gov ID
- NCT02814565
- Acronym / sponsor ID
- CYC-RR-001
- Keywords
- Drug therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- 10 Feb 2017 (actual)
- Study completion
- 14 Mar 2017 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Posted 8 Apr 2019
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 was to assess the effect of cyclobenzaprine hydrochloride (HCl) extended release (CER) 15 mg capsule once daily in participants with muscle spasms associated with acute painful musculoskeletal conditions.
Detailed description
The drug being tested in this study was cyclobenzaprine hydrochloride (HCl) extended-release (CER). CER was being tested to treat participants who had muscle spasms associated with acute painful musculoskeletal conditions. This study looked at medication helpfulness, relief from muscle spasms and pain, and improvement in range of motion and daily living activities.
The study enrolled 180 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups which remained undisclosed to the participant and study doctor during the study:
- CER 15 mg
- Placebo (dummy inactive pill) - this was a capsule that looks like the study drug but had no active ingredient
All participants were asked to take one capsule at the same time each day throughout the study.
This multi-center trial was conducted in the Russian Federation. The overall time to participate in this study was up to 45 days. Participants made multiple visits to the clinic, and were contacted by telephone after the last dose of study drug for a follow-up assessment.
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 |
|---|---|---|
| Cyclobenzaprine HCl 15 mg | Experimental | Drug: Cyclobenzaprine HClCyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days. |
| Placebo | Placebo comparator | Drug: PlaceboCyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Is experiencing for no more than 14 days cervical or lower back pain (as assessed by the participant) due to muscle spasms (confirmed by the physician) associated with acute, painful musculoskeletal conditions.
- Is male or female and aged 18 to 50 years, inclusive.
- Female participants require to be either 2 years postmenopausal or surgically sterile by bilateral tubal ligation, hysterectomy, or bilateral oophorectomy, or, if premenopausal, had to be using an approved contraceptive method.
Key exclusion criteria (39 listed)
- Has muscular pain secondary to acute trauma or fractures (e.g., due to osteoporosis). Such conditions could have been ruled out based on medical history, x-ray, or physical examination.
- Has received any investigational compound within 30 days prior to Screening.
- If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
- Has a history of drug abuse or recent (within the last 12 months) history of excessive alcohol consumption defined as >2 drinks/day (>90 ml of 80 proof alcohol or equivalent).
- Has mild, moderate, severe liver impairment.
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 |
|---|---|---|
| Cyclobenzaprine HClAlso: Myorix®, AMRIX®Cyclobenzaprine HCl extended-release capsules | Drug | Cyclobenzaprine HCl 15 mg |
| PlaceboCyclobenzaprine HCl extended release placebo-matching capsules | Drug | Placebo |
Primary outcome
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment
Time frame: Day 3
Participants assessed the study medication helpfulness on a daily basis (in the daily diary), using the following 5-point rating scale: "How would you rate this study medication in improving your condition?" "0 = poor", "1 = fair", "2 = good", "3 = very good", "4 = excellent".
9 secondary outcomes
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment
Time frame: Days 7 and 14
Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment
Time frame: Day 3
Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment
Time frame: Days 7 and 15
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Time frame: Days 3, 7, and 14
Percentage of Responders on Days 3, 7, and 14 of Treatment
Time frame: Days 3, 7, and 14
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Time frame: Days 3, 7, and 15
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Time frame: Days 3, 7, and 15
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Time frame: Days 3, 7, and 15
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Time frame: Days 3, 7, and 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- 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.
Medical Director Clinical Science study director
Takeda
10 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 Cyclobenzaprine HCl in people with Neck Pain and Back Pain, run by Takeda at 10 sites in Russia.
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 7 inclusion and 39 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 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Russia. 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 8 Apr 2019). 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 Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment (time frame: Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.