Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin

NCT02814565 | Completed Phase 3 Results

• 2 other identifiers: CYC-RR-001U1111-1162-4846
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Neck Pain; Back Pain; Spasm

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• 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".

  Day 3

Secondary Outcomes (9)

• Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment

  Days 7 and 14

• Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment

  Day 3

• Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment

  Days 7 and 15

• Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment

  Days 3, 7, and 14

• Percentage of Responders on Days 3, 7, and 14 of Treatment

  Days 3, 7, and 14

Study Arms (2)

Cyclobenzaprine HCl 15 mg

EXPERIMENTAL

Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.

Drug: Cyclobenzaprine HCl

Placebo

PLACEBO COMPARATOR

Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.

Drug: Placebo

Interventions

Cyclobenzaprine HCl DRUG

Cyclobenzaprine HCl extended-release capsules

Also known as: Myorix®, AMRIX®

Cyclobenzaprine HCl 15 mg

Placebo DRUG

Cyclobenzaprine HCl extended release placebo-matching capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Takeda: lead

Study Sites (10)

Unknown Facility

Lipetsk, Lipetsk Oblast, Russia

Location

Unknown Facility

Saransk, Respublika Mordoviya, Russia

Location

Unknown Facility

Yekaterinburg, Sverdlovsk Oblast, Russia

Location

Unknown Facility

Kazan', Tatarstan Republic, Russia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Nizhny Novgorod, Russia

Location

Unknown Facility

Novosibirsk, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Tver', Russia

Location

Unknown Facility

Yaroslavl, Russia

Location

MeSH Terms

Conditions

Neck Pain; Back Pain; Spasm

Interventions

cyclobenzaprine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 27, 2016
• Study Start: October 12, 2016
• Primary Completion: February 10, 2017
• Study Completion: March 14, 2017
• Last Updated: April 8, 2019
• Results First Posted: April 8, 2019

Record last verified: 2019-01

Locations

RU (10)