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Clinical Drug Investigation

, Volume 14, Issue 3, pp 157–164 | Cite as

Comparison of the Analgesic Efficacy and Tolerability of Tramadol 100mg Sustained-Release Tablets and Tramadol 50mg Capsules for the Treatment of Chronic Low Back Pain

  • J. Sorge
  • Th. Stadler
Clinical Use

Summary

This multicentre, randomised, double-blind, parallel-group study was designed to examine the analgesic efficacy and tolerability of a newly developed tramadol slow-release (SR) tablet in comparison with immediate-release tramadol capsules in patients with chronic low back pain which had persisted despite intervention with other pharmacological and/or nonpharmacological measures. 103 patients were treated with tramadol SR tablets twice daily (2 × 100 mg/day) and 102 patients with capsules 4 times daily (4 × 50 mg/day) over a period of 3 weeks. The medication in both groups (verum/placebo) was administered 4 times daily to ensure the double-blind character of the study (‘double-dummy technique’). In case of insufficient pain relief the patients received 2 × 200mg SR/day as an escape medication (open design). Daily pain intensity was assessed by patients on a 4-step verbal rating scale. At the end of the study retrograde assessment of analgesia was done by the patient using a 5-step classification. Sufficient pain relief could be achieved in approximately 60% of the patients (116 patients) who completed the 3-week treatment period. There was no difference in pain relief (SR 59% and capsules 59%) and in course of pain intensity between both groups. Furthermore, 30 patients (15.3%) were satisfactorily treated with the escape medication. Adverse events were reported at a similar rate in both groups (54.4% with the SR tablet formulation and 52.9% with the capsules). The main adverse events were nausea (16.6%), dizziness (14.1%), vomiting (9.8%), tiredness (7.8%), diaphoresis (6.3%), headache (6.3%), constipation (6.3%) and dry mouth (6.3%). With the exception of diaphoresis, constipation and dry mouth, adverse events decreased in incidence during the study. The results confirmed the equivalence with regard to efficacy and tolerability of twice-daily administration of tramadol SR tablets compared with 4-times-daily administration of tramadol capsules.

Keywords

Adis International Limited Tramadol Drug Invest Chronic Back Pain Verbal Rating Scale 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Adis International Limited 1997

Authors and Affiliations

  • J. Sorge
    • 1
  • Th. Stadler
    • 2
  1. 1.Department of AnaesthesiologyUniversity HospitalHannoverGermany
  2. 2.Medical DepartmentGrünenthal GmbHAachenGermany

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