WHO ICTRP trial
Clinical study to assess the efficacy and safety of Dalumin in patients with…
ISRCTN96439578 · International Standard Randomised Controlled Trial Number (ISRCTN) · Not Recruiting
Key facts
| Trial ID | ISRCTN96439578 |
|---|---|
| Public title | Clinical study to assess the efficacy and safety of Dalumin in patients with somatoform disorders |
| Scientific title | Multi-center, double-blind, placebo-controlled, randomized phase II study to assess the efficacy, safety and tolerability of Dalumin (WS® 1090) in patients with somatoform disorders |
| Primary sponsor | Dr. Willmar Schwabe GmbH & Co. KG (Germany) |
| Registry | International Standard Randomised Controlled Trial Number (ISRCTN) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase II |
| Countries | Germany |
| Conditions | Somatization disorder (ICD 10, F45.0); Undifferentiated somatoform disorder (ICD 10, F45.1); Pain disorder (ICD 10, F45.4) Mental and Behavioural Disorders Somatization disorder |
| Interventions | The patients take two tablets (daily dose: placebo or Dalumin 600 mg or Dalumin 1200 mg) in the morning orally for 70 days. Randomization is carried out by a member of the sponsor who is not directly involved in the study conduct. The… |
| Registration date | Oct 6, 2014 |
| Target size | 450 |
| Secondary IDs | 561501.01.004 |
| Registry page | isrctn.com |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: