Comparison of a triple therapy versus monotherapy in patients with acute mechanical low back and/or cervical pain

Combined nonsteroidal anti-inflammatory drug, muscle relaxant, and caffeine versus nonsteroidal anti-inflammatory drug or mucle relaxant monotherapy for acute mechanical low back and/or cervical pain. A double blind, randomized, multicenter, phase III study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT138807012498N1

Enrollment

714

Registered

2009-10-24

Start date

2009-12-07

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute mechanical low back and/or cervical pain. Dorsalgia, Cervicalgia, low back pain

Interventions

Intervention 1: naproxen 500 mg + cyclobenzaprine 5 mg + caffeine 100 mg (oral pills, once daily, in the morning)

naproxen 500 mg + cyclobenzaprine 5 mg (pills, once daily, in the evening), Duration: 10 days. Intervention 2: naproxen 500 mg (oral pills, twice a day). Duration: 10 days. Intervention 3: cyclobenza

Treatment - Drugs

naproxen 500 mg + cyclobenzaprine 5 mg + caffeine 100 mg (oral pills, once daily, in the morning)

naproxen 500 mg + cyclobenzaprine 5 mg (pills, once daily, in the evening), Duration: 10 days

naproxen 500 mg (oral pills, twice a day). Duration: 10 days

cyclobenzaprine 5 mg (oral pills, twice a day). Duration: 10 days

Eligibility

Sex/Gender

Male

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria -Male or female subjects, 18 to 65 years of age -Written informed consent -Having acute mechanical lower back and/or cervical pain -VAS score minimum of 50 mm at time of entry into study. Exclusion criteria -Subject is pregnant or lactating woman , or a woman of childbearing potential not using an acceptable method of contraception -Medical history or physical examination results that suggest the pain, symptoms or signs are caused by a serious medical condition (e.g., fever in the last days, diabetes, cancer, rheumatic diseases, cardiac, liver, renal diseases) -History of active peptic ulcer or gastrointestinal (GI) bleeding, history of gastric pain with NSAIDs, -Known allergies, hypersensitivity, or intolerance to any drugs used in the study -Known or suspected history of alcohol or drug abuse -History of epilepsy or recurrent seizures -Creatinine > 1.3 mg/dl

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Visual analogue scale (VAS)- pain. Timepoint: 3rd day of tretament. Method of measurement: Pain VAS scale.	—

Secondary

Measure	Time frame
Quality of life evaluation. Timepoint: first visit and last visit (10 days). Method of measurement: SF-36 (Medical Otcomes Study 36 – Item Short-Form Health Survey).	—

Countries

Brazil

Contacts

Public ContactFabio Ikedo

Ache Laboratories

fabio.ikedo@ache.com.br00551126088181

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026