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 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
What does the study involve?
Participants are randomly allocated to one of two groups. One group receives Dalumin for 10 weeks. The other group takes a placebo (dummy) instead. The severity of the symptoms of the disease are measured after 1, 2, 4, 7 and 10 weeks of treatment.
What are the possible benefits and risks of participating?
Participants 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?
About 40 selected centres (medical practices) in Germany
When is the study starting and how long is it expected to run for?
June 2014 to June 2016
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
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 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. Aged 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
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