A Study of the Efficacy and Safety of Tramadol HCl/Acetaminophen, Hydrocodone Bitartrate/Acetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament
Condition: Sprains and Strains; Pain
MeSH terms: Sprains and Strains
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to explore the pain-relieving effects and safety of two
      analgesic treatment regimens as compared to placebo in patients experiencing acute
      musculoskeletal pain. Patients who are experiencing at least moderate acute musculoskeletal
      pain from an ankle sprain severe enough to require prescription pain relief medication will
      be randomized to receive either tramadol HCl/acetaminophen, hydrocodone
      bitartrate/acetaminophen or placebo.
    

Detailed description: 
      Tramadol HCl/acetaminophen is approved for short-term (five days or less) management of acute
      pain. The combination of tramadol HCl/acetaminophen provides a more rapid onset of action
      compared with tramadol HCl alone and a longer duration of action than acetaminophen alone.
      Therefore, the combination of tramadol HCl/acetaminophen may be effective for the treatment
      of acute musculoskeletal pain. The current study is a multicenter, randomized, double-blind,
      inpatient/outpatient, active-controlled, placebo-controlled, parallel-group study. Patients
      who are experiencing at least moderate acute musculoskeletal pain from an ankle sprain severe
      enough to require prescription medication will be enrolled. Patients will be randomized to
      receive either oral tramadol HCl/acetaminophen, hydrocodone bitartrate/acetaminophen or
      placebo. Patients will receive 2 capsules tramadol HCl/acetaminophen 37.5/325 milligrams or 1
      capsule hydrocodone bitartrate/acetaminophen 7.5/650 milligrams + 1 capsule placebo or 2
      capsules placebo. Patient may take 1 or 2 capsules up to 4 times daily as needed but no more
      than 8 capsules per day for 5 daysThe first dose of study medication will be given at the
      study site. Patients will complete a Pain Visual Analog Scale, Pain Relief Rating Scale and
      Pain Intensity Scale at 1, 2, 3 and 4 hours after the first dose of study medication. On Day
      1, after the 4-hour evaluations, patients will be dispensed study medication for use
      throughout the rest of the study. Patients will also evaluate and record in a daily diary the
      pain intensity ratings and pain relief scores for Days 1-5 of the double-blind phase. At the
      final visit, patients will complete a Pain Intensity Scale and Pain Relief Rating Scale, an
      Activity Impairment Assessment and a Subject Overall Medication Assessment. At the first
      dose, patients are dispensed 2 capsules of study medication. Thereafter, patients may take 1
      or 2 capsules of study medication orally up to 4 times per day, as needed for pain, but no
      more than 8 capsules per day. The objective of this study is to compare the pain-relieving
      effectiveness and safety of tramadol HCl/acetaminophen versus hydrocodone
      bitartrate/acetaminophen versus placebo for the treatment of acute musculoskeletal pain from
      an ankle sprain with a partial ligament tear.

      2 capsules tramadol HCl/acetaminophen 37.5/325 milligrams or 1 capsule hydrocodone
      bitartrate/acetaminophen 7.5/650 milligrams + 1 capsule placebo or 2 capsules placebo;
      patient may take 1 or 2 capsules orally up to 4 times daily as needed but no more than 8
      capsules per day for 5 days
    

Intervention name(s): tramadol HCl + acetaminophen; hydrocodone bitartrate + acetaminophen; placebo
Intervention type(s): Drug
Intervention MeSH terms: Acetaminophen; Tramadol; Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: musculoskeletal; Pain; sprained ankle; ligament; sprain; ankle