Condition category
Mental and Behavioural Disorders
Date applied
22/05/2014
Date assigned
10/06/2014
Last edited
10/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Dalumin is an extract of a plant herb called Filipendula ulmaria. In studies with healthy people Dalumin was safe in doses up to 2400 mg. The main aim of the study is to find out how effective Dalumin is at treating patients with somatoform disorders, a disease with physical symptoms that cannot be explained by a medical condition.

Who can participate?
Adult men and women with somatoform disorders can participate in the study.

What does the study involve?
Patients will be randomly allocated to one of two groups. One group will receive Dalumin for 10 weeks. The other group will take a placebo (dummy) instead. The severity of the symptoms of the disease will be measured after 1, 2, 4, 7 and 10 weeks of treatment.

What are the possible benefits and risks of participating?
The patients who receive Dalumin could experience an improvement of their somatoform symptoms. There is no evidence available from the current information about any risks involved.

Where is the study run from?
The study will be performed in about 40 selected centres (medical practices) in Germany.

When is study starting and how long is it expected to run for?
The study will start in June 2014 and will run for about two years until the required number of 450 patients has been recruited and treated.

Who is funding the study?
Dr Willmar Schwabe GmbH & Co. KG (Germany).

Who is the main contact?
Dr Stephan Klement
stephan.klement@schwabe.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hans-Peter Volz

ORCID ID

Contact details

Balthasar-Neumann-Platz 1
Werneck
97444
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

561501.01.004

Study information

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

Acronym

Study hypothesis

The objective of the study is to assess the efficacy of Dalumin in the treatment of patients with somatization disorder in comparing the change of the Hamilton Anxiety Scale total subscore somatic anxiety or the change of Somatic Symptom Inventory subset pain between baseline and Week 10 between Dalumin and placebo.

Ethics approval

Ethics Committee at the Medical Faculty of the University of Würzburg (Ethikkommission bei der Medizinischen Fakultät der Universität Würzburg); 08/05/2014; ref. 58/14_ff

Study design

Multi-centre randomized placebo-controlled double-blind phase II study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Somatization disorder (ICD 10, F45.0); Undifferentiated somatoform disorder (ICD 10, F45.1); Pain disorder (ICD 10, F45.4)

Intervention

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 investigators receive numbered study medication in blocks of six. If a patient is to be randomised, he/she receives the drugs with the lowest available drug number.

Intervention type

Drug

Phase

Phase II

Drug names

Dalumin

Primary outcome measures

1. The individual difference of the total score of the Hamilton Rating Scale for Anxiety, somatic subscore (HAMAsom) between baseline and end of treatment (Week 10 or end of treatment in case of premature study termination)
2. Individual difference of the total score of the Somatic Symptom Inventory subset pain (SSIsp) between baseline and end of treatment (Week 10 or end of treatment in case of premature study termination) comparing Dalumin and placebo

Secondary outcome measures

1. Response criteria based on the HAMAsom total and on the SSIsp total score
2. Difference of the total score of the Montgomery-Asberg Depression Rating Scale (MADRS) between baseline and end of treatment. Response criteria based on the MADRS total score
3. Individual difference of single items of the HAMAsom, single items of the MADRS, total score and single items of the SSIsp; total score and subscales of the Sheehan Disability
4. Clinical Global Impressions of severity of disorder (CGI - item 1): Clinical Global Impressions of change from baseline (CGI - item 2)
5. Visual Analogue Scale overall pain (VASop)
6. Symptom Checklist 90 (SCL 90)
7. Frequency of patients who discontinue the study prematurely due to inefficacy
8. Adverse events, Laboratory data, ECG, vital signs

Overall trial start date

30/06/2014

Overall trial end date

30/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of somatisation disorder
2. Undifferentiated somatoform disorder or pain disorder
3. Age: over 18 years
4. Severity of disorder: HAMAsom score ≥ 12, SSIsp 3 of 5 items ≥ moderate
5. BMI between 18 and 29.9 kg/m2
6. Written informed consent
7. Use of two different forms of highly effective contraception by females with childbearing potential

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

450

Participant exclusion criteria

1. Any axis I disorder other than study indication within 6 months before the study
2. Risk of suicide or previous suicide attempt or clear display of autoaggressive behavior
3. History or evidence of alcohol and/or substance abuse or dependence
4. Current use of other psychotropic drugs within fivefold half-life of the drug before the baseline visit
5. History of hypersensitivity to Filipendula ulmaria or salicylates
6. Any unstable acute medical disorder
7. Unacceptability to discontinue or likelihood to need medication during the study that is prohibited as concomitant treatment
8. Non-medical psychiatric treatment during the course of the study
9. Clinical significant abnormality of ECG and/or laboratory value(s)
10. Pregnancy or lactation

Recruitment start date

30/06/2014

Recruitment end date

30/06/2016

Locations

Countries of recruitment

Germany

Trial participating centre

Balthasar-Neumann-Platz 1
Werneck
97444
Germany

Sponsor information

Organisation

Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Sponsor details

Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Dr Willmar Schwabe GmbH & Co. KG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes