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Acute Low Back PainPhase 3NCT00643383

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

A Phase 3 study testing Combination drug (Acetaminophen + Tramadol) in people with Acute Low Back Pain, run by Labopharm Inc. at 38 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Low Back Pain
What is being tested?
Combination drug (Acetaminophen + Tramadol)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
277 participants
Where
38 sitesin 2 countries
Study dates
Mar 2008to Feb 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

38 sites in 2 countries.

38 sites in 2 countries

Canada20 sites

  • Study site

    Bathurst, New Brunswick, E2A4X7

  • Study site

    Cowansville, Quebec, J2K2X9

  • Study site

    Drummondville, Quebec, J2B7T1

  • Study site

    Gatineau, Quebec, J9A1K7

  • Study site

    Granby, Quebec, J2G8Z9

  • Study site

    Greater Sudbury, Ontario, P3E1H5

  • Study site

    Mirabel, Quebec, J7J2K8

  • Study site

    Montreal, Quebec, H1S3A9

  • Study site

    Montreal, Quebec, H4N2W2

  • Study site

    Mount Pearl, Newfoundland and Labrador, A1N1W7

  • Study site

    Newmarket, Ontario, L3Y5G8

  • Study site

    Newmarket, Ontario, L3Y7V1

  • Study site

    Pointe-Claire, Quebec, H9R4S3

  • Study site

    Québec, Quebec, G1G4A2

  • Study site

    Québec, Quebec, G1V4X7

  • Study site

    Sarnia, Ontario, N7T4X3

  • Study site

    Sherbrooke, Quebec, J1H1Z1

  • Study site

    Toronto, Ontario, M9V4B4

  • Study site

    Toronto, Ontario, M9W4L6

  • Study site

    Trois-Rivières, Quebec, G8T7A1

Other trials in Canada

United States18 sites

  • Study site

    Baton Rouge, Louisiana, 70809

  • Study site

    Brockton, Massachusetts, 02301

  • Study site

    Bryan, Texas, 77082

  • Study site

    Centennial, Colorado, 80112

  • Study site

    Crossville, Tennessee, 38555

  • Study site

    Dallas, Texas, 75235

  • Study site

    Hialeah, Florida, 33013

  • Study site

    Houston, Texas, 77074

  • Study site

    Indianapolis, Indiana, 46254

  • Study site

    Largo, Florida, 33770

  • Study site

    Minneapolis, Minnesota, 55415

  • Study site

    Montgomery, Alabama, 36117

  • Study site

    New Port Richey, Florida, 34652

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Rapid City, South Dakota, 57702

  • Study site

    Salt Lake City, Utah, 84109

  • Study site

    Salt Lake City, Utah, 84121

  • Study site

    Waterloo, Iowa, 50702

Other trials in United States

About this study

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.

Being tested
Combination drug (Acetaminophen + Tramadol), Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combination drug (Acetaminophen + Tramadol)Drug

  • PlaceboDrug

Study groups in NCT00643383
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Drug: Combination drug (Acetaminophen + Tramadol)
2Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity change from Baseline

Secondary outcomes (2)

  1. Overall satisfaction with the study medication

  2. Safety evaluation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionJan 2009
  4. Study completionFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00643383
Sponsor's protocol ID
06CCL3-001
Other IDs
NCT00643383
Status last verified
Apr 2012
First submitted
20 Mar 2008
Last updated
1 May 2012
Results posted
No

Publications

  • Lasko B, Levitt RJ, Rainsford KD, Bouchard S, Rozova A, Robertson S. Extended-release tramadol/paracetamol in moderate-to-severe pain: a randomized, placebo-controlled study in patients with acute low back pain. Curr Med Res Opin. 2012 May;28(5):847-57. doi: 10.1185/03007995.2012.681035. Epub 2012 Apr 25.

    PubMed 22458917

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Combination drug (Acetaminophen + Tramadol) in people with Acute Low Back Pain, run by Labopharm Inc. at 38 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity change from Baseline. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00643383, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2012.

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