Analgesic Efficacy and Tolerability of Tramadol 100mg Sustained-Release Capsules in Patients with Moderate to Severe Chronic Low Back Pain

Raber, Marc; Hofmann, S.; Junge, Klaus; Momberger, H; Kuhn, Diane

doi:10.2165/00044011-199917060-00001

Cited by 29 publications

(25 citation statements)

References 12 publications

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“…They are also in line with non-inferiority margins recently used in different chronic pain conditions, including chronic low back pain [46], osteoarthritis [47], and ankylosing spondylitis [48]. …”

Section: Discussionmentioning

confidence: 77%

Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials

Gerlinger

Schumacher

Faustmann

et al. 2010

Health Qual Life Outcomes

100

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BackgroundWhen comparing active treatments, a non-inferiority (or one-sided equivalence) study design is often used. This design requires the definition of a non-inferiority margin, the threshold value of clinical relevance. In recent studies, a non-inferiority margin of 15 mm has been used for the change in endometriosis-associated pelvic pain (EAPP) on a visual analog scale (VAS). However, this value was derived from other chronic painful conditions and its validation in EAPP was lacking.MethodsData were analyzed from two placebo-controlled studies of active treatments in endometriosis, including 281 patients with laparoscopically-confirmed endometriosis and moderate-to-severe EAPP. Patients recorded EAPP on a VAS at baseline and the end of treatment. Patients also assessed their satisfaction with treatment on a modified Clinical Global Impression scale. Changes in VAS score were compared with patients' self-assessments to derive an empirically validated non-inferiority margin. This anchor-based value was compared to a non-inferiority margin derived using the conventional half standard deviation rule for minimal clinically important difference (MCID) in patient-reported outcomes.ResultsAnchor-based and distribution-based MCIDs were-7.8 mm and-8.6 mm, respectively.ConclusionsAn empirically validated non-inferiority margin of 10 mm for EAPP measured on a VAS is appropriate to compare treatments in endometriosis.

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Section: Discussionmentioning

confidence: 77%

Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials

Gerlinger

Schumacher

Faustmann

et al. 2010

Health Qual Life Outcomes

100

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“…The mean elimination half-life is~6 hours 2 and requires dosing every 6 hours in order to maintain optimal relief of chronic pain. 3,4 Consequently, once-daily extended-release tablets have been formulated (tramadol ER). Long-term treatment with sustained-release tramadol once daily is generally safe in patients with osteoarthritis or refractory low back pain 5 and is well tolerated.…”

Section: Introductionmentioning

confidence: 99%

Use of hydrophilic natural gums in formulation of sustained-release matrix tablets of tramadol hydrochloride

2006

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The objective of this work was to develop matrix sustainedrelease tablets of highly water-soluble tramadol HCl using natural gums (xanthan [X gum] and guar [G gum]) as costeffective, nontoxic, easily available, and suitable hydrophilic matrix systems compared with the extensively investigated hydrophilic matrices (ie, hydroxypropyl methylcellulose [HPMC]/carboxymethyl cellulose [CMC] with respect to in vitro drug release rate) and hydration rate of the polymers. Matrix tablets of tramadol (dose 100 mg) were produced by direct compression method. Different ratios of 100:0, 80:20, 60:40, 20:80, 0:100 of G gum (or X):HPMC, X gum:G gum, and triple mixture of these polymers (G gum, X gum, HPMC) were applied. After evaluation of physical characteristics of tablets, the dissolution test was performed in the phosphate buffer media (pH 7.4) up to 8 hours. Tablets with only X had the highest mean dissolution time (MDT), the least dissolution efficiency (DE 8 %), and released the drug following a zero-order model via swelling, diffusion, and erosion mechanisms. Guar gum alone could not efficiently control the drug release, while X and all combinations of natural gums with HPMC could retard tramadol HCl release. However, according to the similarity factor ( f 2 ), pure HPMC and H 8 G 2 were the most similar formulations to Topalgic-LP as the reference standard.

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“…In a controlled clinical trial in patients with severe chronic low back pain, patients reported adverse events more frequently following administration of immediate‐release tramadol than sustained‐release tramadol. The decreased incidence and severity of adverse events was explained by slower absorption of tramadol and decreased peak tramadol concentrations 25 . Thus, there appears to be a relationship between C max /t max and tolerability.…”

Section: Discussionmentioning

confidence: 95%

Comparative Pharmacokinetics of a Once‐Daily Tramadol Extended‐Release Tablet and an Immediate‐Release Reference Product Following Single‐Dose and Multiple‐Dose Administration

Fradette

Potgieter³

et al. 2010

The Journal of Clinical Pharma

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The pharmacokinetics of a once-daily formulation of tramadol (Tramadol Contramid OAD 200-mg tablets) following single-dose and multiple-dose administration was compared with that of an immediate-release product (tramadol IR 50-mg tablets) in 2 separate studies. In both studies, AUC parameters met bioequivalence criteria, whereas C(max) of Tramadol Contramid OAD was lower than that of tramadol IR following a 200-mg daily dosage. After single-dose administration, the mean tramadol concentration at 1 hour postdose was within the range associated with analgesic efficacy (>100 ng/mL), and the mean concentration remained above this level for the remainder of the dosing interval. Steady state was attained within 48 hours following multiple-dose administration. Tramadol Contramid OAD provides a rapid rise in plasma concentrations and an equivalent daily systemic exposure as tramadol IR, with a reduction in peak plasma concentrations.

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Analgesic Efficacy and Tolerability of Tramadol 100mg Sustained-Release Capsules in Patients with Moderate to Severe Chronic Low Back Pain

Cited by 29 publications

References 12 publications

Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials

Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials

Use of hydrophilic natural gums in formulation of sustained-release matrix tablets of tramadol hydrochloride

Comparative Pharmacokinetics of a Once‐Daily Tramadol Extended‐Release Tablet and an Immediate‐Release Reference Product Following Single‐Dose and Multiple‐Dose Administration

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