A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Acetaminophen and Tramadol Combination BID Versus Placebo for the Treatment of Acute Low Back Pain

Acute Low Back Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643383
• Other study ID #: 06CCL3-001
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2008
• Last updated: April 30, 2012
• Start date: March 2008
• Est. completion date: February 2009

Study information

• Verified date: April 2012
• Source: Labopharm Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

A multi-center placebo controlled, double-blind, trial comparing the analgesic efficacy and safety of Acetram Contramid® BID versus placebo for the treatment of acute low back pain in patients between 18 and 80 yrs of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Males or females in generally good health aged 18-80 years with moderate to severe acute low back pain.

• Current acute low back pain episode within 48h prior to study entry.

• Pain must be moderate to severe following incident

Exclusion Criteria:

• Chronic low back pain

• Ongoing or history of alcohol or drug abuse

• Body Mass Index greater 39

• Treatment within the last 3 weeks with monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds; neuroleptics; selective serotonin reuptake inhibitors

• Known history or symptoms suspicious for cancer

• Significant renal or liver disease

• Spinal surgery within 1 year of study entry.

• Subjects who are pregnant or lactating.

• Subjects with unstable medical disease.

• Subjects who have received treatment with an investigational product/device with 30 days prior to study entry.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Low Back Pain
• Back Pain
• Low Back Pain

Intervention

Drug:
• Combination drug (Acetaminophen + Tramadol)

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Labopharm Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity change from Baseline
Secondary	Overall satisfaction with the study medication
Secondary	Safety evaluation