Final Version Circular Rowatinex Clinical Report

Integrated Clinical and Statistical Study Report

Finally, we have pleasure in enclosing the very important Study Report and Publications on our product
ROWATINEX.



1. INTEGRATED CLINICAL AND STATISTICAL STUDY REPORT

“Trial to Evaluate the Efficacy of ROWATINEX on Elimination of Fragments of Calculi Generated by ESWL”
A Placebo Controlled, Multi-Centre Study
Prof. Dr. I. Romics
Budapest, Hungary, February 2009.

Overall, this was a randomised double-blind, parallel group study conducted in six centres in Hungary. The objectives of the study were to evaluate the safety and efficacy of ROWATINEX (3 x 2 capsules / day for 12 weeks) and Placebo capsules (same dosage regime) in the treatment of patients with Nephrolithiasis
beginning on the day of the treatment with ESWL.


A total of 222 patients were enrolled into the study in the six study centres:


180 patients (ROWATINEX = 92, Placebo = 88) in the per protocol analysis (PP)
204 patients (ROWATINEX = 106, Placebo = 98) in the intention to treat analysis (ITT)
222 patients (ROWATINEX = 112, Placebo = 110) in the safety analysis (SA)


The study consists of a screening phase, a 12-week treatment phase and a 2-week follow-up phase. Treatment with ROWATINEX (3 x 2 capsules / day) or Placebo was administered during the treatment phase. Patients were followed up at 1, 4, 8, and 12 weeks after starting treatment and 2 weeks after
stopping treatment.


This was by far the largest and best designed and conducted study of ROWATINEX in the treatment of urinary calculi.

The patient population was clearly defined in an appropriate and comprehensive protocol. The inclusion of a Placebo-treated group was justified in the absence of any previous large Placebo-controlled studies of ROWATINEX for this indication.
 
ROWATINEX was superior to Placebo in the primary efficacy measure, rate of patients with stone-free status after 12 weeks of therapy. The difference in the rate of stone-free patients of 17.9 % is statistically significant and is also clinically relevant (ITT).
 
ROWATINEX was even more efficacious than Placebo in the PP population and stone-free status was achieved one month earlier with ROWATINEX than with Placebo. There was no significant difference in the safety profiles of ROWATINEX and Placebo.

This study provides the most convincing evidence to date of the efficacy and safety of ROWATINEX in the elimination of calculi fragments generated by ESWL as compared to Placebo.

 

2. EUROPEAN UROLOGY SUPPLEMENTS

“Terpenes in Urolithiasis” – Proceedings of the ROWA Symposium Düsseldorf, Germany, September 2010
Guest Editor: Thomas Knoll, Sindelfingen, Germany
Vol. 9, Issue 12, December 2010, Page No. 819-825

Overall, this Symposium specifically dealt with the management and treatment of Urolithiasis which clearly illustrates from the various references outlined that the product ROWATINEX demonstrates the superiority of the terpene combination compared to Placebo in the treatment of urinary stone-related symptoms.
ROWATINEX has its defined place in the pharmacological armamentarium of Urolithiasis.

Please refer to pages 819-825 in which the above clinical trial is featured.
http://www.europeanurology-supplement.com/article/PIIS1569905610001557/fulltext

 

3. UROLOGIA INTERNATIONALIS

“A Special Terpene Combination (Rowatinex®) Improves Stone Clearance after Extracorporeal Shockwave Lithotripsy in Urolithiasis Patients: Results of a Placebo-Controlled Randomised Controlled Trial”
Imre Romics, György Siller, Ralf Kohnen, Stelios Mavrogenis, József Varga, Endre Holman
Vol. 86, No. 1, 2011, Page No. 102-109

The objective of this study was to investigate the safety and efficacy of a special terpene combination in the treatment of patients with Urolithiasis after extracorporeal shockwave lithotripsy (ESWL).

Overall, this is the first randomised, double-blind, Placebo-controlled multi-centre study demonstrating the superiority of the terpene combination as compared to Placebo (see also Point 1 – Integrated Clinical and Statistical Study Report) with respect to the rate of stone-free patients and the time to stone-free status
during 12 weeks of treatment after ESWL. Treatment with the terpene combination was well tolerated and safe. The terpene combination was found to be an efficacious treatment in eliminating calculi fragments generated by ESWL as compared to Placebo.

 

4. SUMMARY

The Study Report, together with the Publications, will be of immense benefit and interest to you and the medical professions, particularly from a safety and marketing perspective. These will also reinforce the product ROWATINEX as an effective and safe medicine in the treatment of calculi fragments generated by ESWL.

ROWATINEX is the first choice in the treatment of Urolithiasis – therefore it is essential to receive your comments, marketing strategy, proposals for Meetings / Symposiums with key Urologists with view to undertaking an aggressive promotional campaign.

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