Spasm Clinical Trial - An Effectiveness & Safety Study of Cyclobenzaprine

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and safety of cyclobenzaprine HCl 5 mg (muscle spasm medication) taken three times a day, alone or in combination with ibuprofen 400 mg or 800 mg (pain relief medication) taken three times a day, for the treatment of back or neck muscle pain with muscle spasm.

Clinical Trial Description

The objective of this multicenter, randomized, open-label, parallel-group, one-week study is to evaluate the effectiveness and safety of cyclobenzaprine HCl 5 mg three times a day for one week, alone or in combination with ibuprofen 400 mg or 800 mg taken three times a day, for acute back or neck muscle pain with muscle spasm. The primary measurement of efficacy is the subject-rated global impression of change after seven days of treatment, compared to baseline. Safety assessments during the study include the monitoring of adverse events, and a physical examination, assessment of vital signs and medical history of any present illnesses conducted during the baseline visit. The study hypothesis is that there will not be a statistically significant difference in patient ratings of global impression of change, muscle spasm, muscle pain, medication helpfulness, and functional ability, between the cyclobenzaprine HCl monotherapy group versus the cyclobenzaprine HCl/ibuprofen 400 mg and cyclobenzaprine HCl/ibuprofen 800 mg groups, for the treatment for acute back or neck muscle pain with spasm. Patients receive cyclobenzaprine HCl 5 mg administered orally three times a day for one week, or cyclobenzaprine HCl 5 mg with ibuprofen 400 mg administered orally three times a day for one week, or cyclobenzaprine HCl 5 mg with ibuprofen 800 mg administered orally three times a day for one week. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00246389
Study type	Interventional
Source	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Contact
Status	Completed
Phase	Phase 4
Completion date	July 2004

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05559255` - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI	N/A
Terminated	`NCT04356352` - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain	Phase 2/Phase 3
Completed	`NCT04748367` - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care	N/A
Completed	`NCT05057988` - Virtual Empowered Relief for Chronic Pain	N/A
Completed	`NCT04466111` - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting	`NCT05868122` - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy	Phase 3
Recruiting	`NCT06206252` - Can Medical Cannabis Affect Opioid Use?
Active, not recruiting	`NCT05006976` - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study	N/A
Completed	`NCT03273114` - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain	N/A
Enrolling by invitation	`NCT06087432` - Is PNF Application Effective on Temporomandibular Dysfunction	N/A
Completed	`NCT05508594` - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001	Phase 2/Phase 3
Recruiting	`NCT03646955` - Partial Breast Versus no Irradiation for Women With Early Breast Cancer	N/A
Active, not recruiting	`NCT03472300` - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed	`NCT03678168` - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries	N/A
Completed	`NCT03931772` - Online Automated Self-Hypnosis Program	N/A
Completed	`NCT03286543` - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System	N/A
Completed	`NCT02913027` - Can We Improve the Comfort of Pelvic Exams?	N/A
Terminated	`NCT02181387` - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?	Phase 4
Recruiting	`NCT06032559` - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment	Phase 3
Active, not recruiting	`NCT03613155` - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms