Randomised, placebo-controlled clinical trial on the efficacy of Roleca® juniper 100 mg for dyspeptic digestive complaints such as cramps in the gastrointestinal tract, flatulence and bloating.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cgbs GbR

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

24 Oct 2023 → 20 Feb 2025

Decision date (initial)

2023-09-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

Randomised, placebo-controlled clinical trial on the efficacy of Roleca® juniper 100 mg for dyspeptic digestive complaints such as cramps in the gastrointestinal tract, flatulence and bloating.

Conditions and MedDRA coding

Treatment of dyspeptic digestive complaints (cramps in the gastrointestinal tract, flatulence, bloating).

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients of either sex between the ages of ≥ 18 years and < 60 years
2. Outpatients with persistent dyspeptic digestive symptoms over the past 3 months
3. Signed informed consent for participation and for collection and pseudonymized sharing of personal data
4. Negative pregnancy test for persons of childbearing potential at visit 1
5. Willingness to use a reliable method of contraception during participation in the clinical trial (Pearl index < 1): Complete abstinence, Sterilization (e.g., bilateral tubal ligation, ovariectomy, hysterectomy), Vasectomy of partner (if sole sexual partner), combined hormonal contraceptives (oral, intravaginal, dermal), progestogen-containing hormonal contraceptives, copper IUD, hormone-containing IUD
6. The 3 specific parameters (discomfort in the upper abdomen, feeling of pressure in the upper abdomen and feeling of fullness) must be classified as at least mild discomfort.

Exclusion criteria 14

1. Uncooperative patients
2. Allergy to peanut or soy
3. Existing alcohol abuse or medication or drug abuse
4. Pregnant or breast-feeding patients or those who plan to become pregnant during the clinical trial
5. Patients who are institutionalized by court order or by order of the authorities
6. Patients incapable of giving consent
7. Patients who do not have sufficient command of the German language (informed consent)
8. Patients who are in a dependent relationship with the sponsor, investigator, other study personnel, or the study site
9. Patients with inflammatory kidney disease or severe kidney disease
10. Patients with diabetes mellitus
11. Patients in whom an organic cause for the dyspeptic complaints has been proven by diagnostics
12. Hypersensitivity to juniper oil, lactose monohydrate, cellulose powder, magnesium stearate (Ph. Eur.) or microcrystalline cellulose.
13. Allergy to the humectant sorbitol (E420)
14. Patients with known galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Prospective documentation of the efficacy of Roleca® Juniper 100 mg vs placebo for dyspeptic digestive complaints, based on the improvement in the patients' quality of life, expressed in a change in the score in the Nepean Dyspepsia Index in the patient diary, with particular comparison of the values after the end of treatment (V3) with the values before treatment (V1) (in particular significant improvement in complaints and feeling of pressure in the upper abdomen and feeling of fullness).

Secondary endpoints 2

1. Prospective documentation of the tolerability, safety and compliance of Roleca® Juniper 100 mg in dyspeptic digestive complaints. Tolerability and safety will be evaluated based on the patient's information in the patient diary regarding tolerability, as well as the number and severity of adverse events reported. Compliance will be analyzed based on documentation of medication taken in the patient diary.
2. Analysis of the intestinal microbiome before and during treatment with Roleca® Wacholder 100 mg for dyspeptic digestive complaints

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cgbs GbR

Sponsor organisation

CGBS GbR

Address

Im Prüfling 21-25

City

Frankfurt

Postcode

60389

Country

Germany

Scientific contact point

Organisation

CGBS GbR

Contact name

Prof Ahmed Madisch

Public contact point

Organisation

CGBS GbR

Contact name

Prof Ahmed Madisch

Third parties 1

Locations

1 EU/EEA country · 2 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 8 files

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

Application history

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