A Pharmacodynamic/Pharmacokinetic Study to Determine the Onset of Analgesic Effect and Plasma Levels of Tramadol in Patients With Acute Low Back Pain Receiving a Single 200 mg Dose of Tramadol Contramid® Once-a-Day
Condition: Acute Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Tramadol Contramid® OAD 200mg
Intervention description: 1 Tramadol Contramid® OAD 200mg tablet daily.
Intervention MeSH terms: Tramadol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Back Pain

Summary:

      The primary objective of this study is to determine the time of onset of analgesic effect of
      Tramadol Contramid® Once-A-Day (OAD) in acute low back pain. Secondary objectives include
      determining the relationship between analgesic effect and plasma levels for Tramadol
      Contramid® OAD and to examine safety after single dose administration of 200 mg of Tramadol
      Contramid® OAD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females in generally good health aged 18-80 years with acute low back pain
             are eligible for this study.

          -  Patients must have pain of moderate to severe intensity on the patient rating of pain
             intensity scale without analgesia.

          -  Oral and written language comprehension at a level sufficient to comply with the
             protocol and complete study-related materials.

          -  Must have signed and dated an REB-approved written Informed Consent form which was
             also signed and dated by the Investigator prior to study participation.

        Exclusion Criteria:

          -  Known history or symptoms suspicious of:

               -  Spinal fracture

               -  Cancer (i.e. constitutional symptoms such as recent unexplained chills or weight
                  loss)

               -  Spinal infection (e.g. IV drug abuse, immunosuppression)

          -  Cauda equina syndrome

          -  Spina bifida

          -  Foot drop

          -  Spinal surgery within 1 year of study entry

          -  Body Mass Index (BMI) > 37

          -  Continuous chronic back pain

          -  More severe pain in a region other than the lower back

          -  Treatment of the back pain with non-pharmacological therapy (e.g. acupuncture
             chiropractic adjustment, Transcutaneous Electrical Nerve Stimulation, physiotherapy
             etc.) in the 3 weeks prior to study entry

          -  Use of any sedative hypnotics, topical preparations/medications and anaesthetics or
             muscle relaxants within 5 half-lives of the dose of study medication

          -  Use of any analgesic within 6 hours of the dose of study medication. In rare cases, if
             a patient is in moderate to severe pain despite having taken a short-acting analgesic
             and if at least 2 hours have passed since the dose of short-acting analgesic, the
             patient may be entered.

          -  A major illness, requiring hospitalisation during the 3 months before commencement of
             the screening period

          -  Unwillingness to stop taking pain medication other than the study medication

          -  Previous failure of treatment with tramadol or discontinuation of treatment with
             tramadol due to adverse events

          -  Treatment within the last 3 weeks with any of the following medications: monoamine
             oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g.
             cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors
             (SSRIs); serotonin-norepinephrine reuptake inhibitors (SNRIs) or any other drug that
             reduces seizure threshold

          -  Treatment with another investigational agent within the last 30 days

          -  History of seizure disorder other than Infantile Febrile Seizures

          -  Previous or current opioid dependency

          -  Bowel disease causing malabsorption

          -  Pregnant or lactating women

          -  Known significant liver disease or symptoms of significant liver disease

          -  Known significant renal disease or symptoms of significant renal disease

          -  Current or past substance abuse or dependence, other than nicotine

          -  Allergy to tramadol or any structurally similar drugs (e.g. opiates)

          -  Any other condition that, in the opinion of the Investigators, would adversely affect
             the patient's ability to complete the study or its measures