Comparison of Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex® (Tizanidine Hydrochloride Tablets) Taken While in the Fed State (Just After a Meal) and in the Fasted State (Before a Meal) in Patients With Moderate to Severe Spasticity.

This study has been completed.
Sponsor:
Information provided by:
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00047580
First received: October 8, 2002
Last updated: June 23, 2005
Last verified: October 2002

October 8, 2002
June 23, 2005
June 2002
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Complete list of historical versions of study NCT00047580 on ClinicalTrials.gov Archive Site
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Comparison of Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex® (Tizanidine Hydrochloride Tablets) Taken While in the Fed State (Just After a Meal) and in the Fasted State (Before a Meal) in Patients With Moderate to Severe Spasticity.
A Multicenter, Open-Label, Randomized, 4-Way Crossover Trial of the Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex (Tizanidine Hydrochloride) Tablets Taken Under Fed and Fasted Conditions in Patients With Moderate to Severe Spasticity

This study is being conducted to compare the impact of somnolence (sleepiness) on cognition (awareness) as well as the safety and effectiveness of tizanidine hydrochloride capsules versus Zanaflex® (tizanidine hydrochloride tablets) taken while in the fed state (just after a meal) and in the fasted state (before a meal) in patients with moderate to severe spasticity.

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Interventional
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Sclerosis
  • Muscle Spasticity
  • Spinal Cord Injury
  • Stroke
Drug: tizanidine hydrochloride capsule
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
September 2002
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Inclusion Criteria:

  • IRB approved ICF must be signed and dated by patient or patient's legal representative
  • Male or Female 18 years of age or older
  • Clinical diagnosis of established spasticity (at least 3 months) secondary to multiple sclerosis, stroke, or spinal cord injury
  • Currently on stable dose of up to 36mg of Zanaflex
  • Must be able to swallow tablets or capsules whole

Exclusion Criteria:

  • Patients with dementia, aphasia, or other deficits in cognition
  • Unwilling or unable to complete cognition test or daily diary
  • Known sensitivity to Zanaflex
  • Taking Zanaflex on an as needed ("prn") basis
  • Currently being treated with drugs having significant effects at the alpha2 receptors whether agonist (i.e., clonidine, methyldopa) or antagonist (i.e., phenothiazines, imipramine)
  • Currently on any other muscle relaxant or any drugs having muscle relaxant properties (including baclofen, dantrolene, diazepam and other benzodiazepines, tranquilizers, narcotic analgesics, high dose neuroleptics, chlormezanone, meprobamate, methocarbamol, orphenadrine, carisoprodol, gabapentin and clonidine
  • Taking any over-the-counter or prescription sleep aids within 30 days prior to screening
  • Use of illegal drugs or legal drugs for recreational purposes or excessive use of alcohol
  • Patients suffering from disabling, symptomatic hypotension (i.e., syncope)
  • Patients having any systemic disease such as renal insufficiency, clinically relevant elevations in hepatic transaminase, severe, uncontrolled systemic hypertension
  • Any clinically significant illnesses, within four weeks of screening
  • Patients with known sleep disorders
  • Patients who participated in a clinical trial within thiry days prior to screening
  • Women of childbearing potential who are pregnant, have a positive serum pregnancy test, lactating, or do not or will not take adequate contraceptive precautions for the duration of trial
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00047580
ELN021-502
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Elan Pharmaceuticals
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Elan Pharmaceuticals
October 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP