PRESENT: Primary care dySpEpsia rikkuNshiTo

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Trial duration

30 Jan 2025 → ongoing

Decision date (initial)

2024-12-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

TSUMURA & Co.

External identifiers

EU CT number

2024-515756-20-00

ClinicalTrials.gov

NCT06482671

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Therapy, Efficacy

Our objective is to study the effect of Rikkunshito on dyspeptic symptoms in FD patients, recruited from primary care in Belgium.

Secondary objectives 1

1. Our objective is to study the effect of Rikkunshito on duodenal mucosal parameters in FD patients. We hypothesize that symptomatic benefit may result from Rikkunshito’s effects on duodenal mucosa barrier function. In addition, these microscopic changes may also have an impact on gastric sensorimotor function in patients with functional dyspepsia.

Conditions and MedDRA coding

Functional Dyspepsia

Study design 2 periods

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Subjects for wich voluntary written informed consent of the participant has been obtained prior to any screening procedures
2. Subjects capable to understand and to comply with the study requirements
3. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
4. Male or female
5. 18 years old or older
6. Newly to be treated FD diagnosis (as per Rome criteria and assessed with the questionnaire in Aprendix 3). Rome Criteria includes: One or more of the following: Bothersome postprandial fullness, Bothersome early satiation, Bothersome epigastric pain, Bothersome epigastric burning AND No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms **Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
7. FD defined by moderate bothersome postprandial fullness or early satiation for 2 to 5 days per week evaluated by the LPDS diary during 2 week of run-in period

Exclusion criteria 11

1. Participant has a history of diabetes mellitus type 1, type 2 (including therapy), eosinophilic esophagitis, coeliac disease or inflammatory bowel disease, major abdominal surgery (except for appendectomy, cholecystectomy or splenectomy).
2. Known allergy to Rikkunshito or any of its ingredients
3. Patients with overweight (BMI>26)
4. Patients taking prohibited medications (see protocol)
5. Patients with active malignancy
6. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive.
7. Patients with predominant symtoms of gastro-oesophageal reflux disease (GERD) or irritable bowel syndrome (IBS)
8. Patients with any active somatic or psychiatric condition that may explain dyspeptic symptoms (stable dose of single antidepressant allowed for psychiatric indication, no limitation for other indications) or severe depression using PHQ-7 (score of 20-27)
9. Patients on PPI therapy or using a PPI in the last 2 weeks prior to enrolment
10. Known HIV, HBV, or HCV infection
11. Significant alcohol use (more than 10 units a week)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of this study is to evaluate the therapeutic effect of Rikkunshito on functional dyspepsia symptoms. This will be assessed by the previously validated Leuven Postprandial Distress Scale (LPDS) diary. The percentage of response after treatment with Rikkunshito compared to placebo. The response rate is assessed with the LPDS daily diary (19). A responder is defined by the clinically relevant difference of 0.7 for the LPDS score (average of 3 PDS questions).

Secondary endpoints 5

1. The effect of Rikkunshito versus placebo on duodenal mucosal parameters before and after treatment.
2. The effect of Rikkunshito versus placebo on individual PDS and EPS clinical symptoms, assessed with the LPDS daily diary symptom questionnaire during the 8 weeks therapy.
3. The effect of Rikkunshito versus placebo on clinical symptoms, assessed with the LPDS daily diary with a minimum clinically important difference of 0.5 for the PDS symptoms (average of 3 questions) by comparing pretreatment baseline scores with the average score during the last 2 weeks on treatment (responder definition).
4. The effect of Rikkunshito versus placebo on quality of life, depression, anxiety and somatization co-morbidity, evaluated by the PAGI-Qol and PHQ questionnaires
5. The effect of Rikkunshito versus placebo on upper gastrointestinal symptoms, evaluated by the PAGI-SYM questionnaire.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Jan Tack

Public contact point

Organisation

UZ Leuven

Contact name

Jan Tack

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 23 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications