Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin
Condition: Neck Pain; Back Pain; Spasm
MeSH terms: Spasm; Back Pain; Neck Pain; Low Back Pain
Intervention: Cyclobenzaprine HCl; Placebo
Intervention description: Cyclobenzaprine HCl extended-release capsules; Cyclobenzaprine HCl extended release placebo-matching capsules
Intervention MeSH terms: Cyclobenzaprine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Drug therapy

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator, the participant is capable of understanding and
             complying with protocol requirements.

          2. Signs and dates a written, informed consent form and any required privacy
             authorization prior to the initiation of any study procedures.

          3. 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.

          4. Is male or female and aged 18 to 50 years, inclusive.

          5. 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.

          6. Female participants of child-bearing potential must have a negative urine human
             chorionic gonadotropin (hCG) test result for pregnancy at study entry.

          7. 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.

        Exclusion Criteria:

          1. 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.

          2. Has received any investigational compound within 30 days prior to Screening.

          3. 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.

          4. 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).

          5. Has mild, moderate, severe liver impairment.

          6. 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.

          7. 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.

          8. Takes or took within last 14 days medications, such as:

               1. selective serotonin reuptake inhibitors (SSRIs);

               2. serotonin norepinephrine reuptake inhibitors (SNRIs);

               3. tricyclic antidepressants (TCAs);

               4. monoamine oxidase (MAO) inhibitors;

               5. tramadol;

               6. bupropion;

               7. meperidine;

               8. verapamil;

               9. non-steroid anti-inflammatory drugs (NSAIDs);

              10. topical anti-inflammatory medications

          9. Has a history or clinical manifestations of significant medical condition, such as:

               1. hyperthyroidism;

               2. acute recovery phase of myocardial infarction;

               3. arrhythmias, heart block or conduction disturbances;

               4. congestive heart failure;

               5. angle-closure glaucoma;

               6. urinary retention;

               7. increased intraocular pressure.

         10. 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.

         11. Has any known condition or disorder that might have affected absorption of the study
             drug.

         12. Has a history of hypersensitivity or allergies to cyclobenzaprine and/or tricyclic
             antidepressants or any of their components.

         13. Has a history of hypersensitivity to any NSAIDs including salicylate sensitivity.

         14. Has a history of thrombocytopenia.

         15. Has a history of gastro-intestinal bleeding, cerebrovascular bleeding or other
             bleeding disorders.

         16. Had active or history of recurrent peptic ulcer/haemorrhage (two or more distinct
             episodes of proven ulceration or bleeding)

         17. Has a history of severe renal impairment

         18. Had a major surgery during the 6 months preceding study entry.

         19. Has a language barrier or any other problems precluding good communication or
             cooperation.

         20. Has any reason to believe that he/she would not be able to complete the evaluations
             needed in this study.

         21. Has a known history of positive screen for hepatitis B surface antigen, hepatitis C
             antibody, or human immunodeficiency virus (HIV) antibody.

         22. Drug abuse in anamnesis.