Non-interventional study Constella®: Constella® for treatment of IBS-C - Efficacy and safety under real life conditions

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005088

Enrollment

2000

Registered

2013-06-19

Start date

2013-07-04

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

moderate to severe Irritable Bowel Syndrome with Constipation (IBS-C) K58.9 K59.0

Interventions

Group 1: Adult patients with moderate to severe Irritable Bowel Syndrome with Constipation (IBS-C) are to be investigated, who will be treated with 290 microgram capsules Constella ® (active ingredien

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: The observation should be performed in patients: • who suffer from moderate to severe Irritable Bowel Syndrom with Constipation (IBS-C) • who are at least 18 years old • who will be treated with Constella® based on the physicians therapeutic decision reached before inclusing the patient into the study

Exclusion criteria

Exclusion criteria: The observation should not be performed in patients • with a known hypersensitivity to the active substance or to any other ingredient of Constella® and/or • a known or suspected mechanical gastrointestinal obstruction. Pregnant women or nursing women as well as women willing to become pregnant during treatment with Constella® may not to be enrolled.

Design outcomes

Primary

Measure	Time frame
Efficacy of Constella® should be determined under real life conditions by following parameters: • Reduction of abdominal pain and bloating after 4 weeks, 3, 6 and 12 months in comparison to the time before therapy started measured by 11-NSR (numeric rating scale) • Incomplete bowel evacuation as subjective sensation of patient • Change of predominant consistency • Physician evaluation of efficacy 6 and 12 month after therapy started Tolerance of Constella® should be determined under real life conditions by following parameters: • Number, intensity and severity of Adverse Events (AE) • Physician evaluation of tolerance 6 and 12 month after therapy started	—

Measure

Time frame

Efficacy of Constella® should be determined under real life conditions by following parameters: • Reduction of abdominal pain and bloating after 4 weeks, 3, 6 and 12 months in comparison to the time before therapy started measured by 11-NSR (numeric rating scale) • Incomplete bowel evacuation as subjective sensation of patient • Change of predominant consistency • Physician evaluation of efficacy 6 and 12 month after therapy started Tolerance of Constella® should be determined under real life conditions by following parameters: • Number, intensity and severity of Adverse Events (AE) • Physician evaluation of tolerance 6 and 12 month after therapy started

—

Secondary

Measure	Time frame
Satisfaction with therapy should be evaluated 4 weeks, 3, 6 and 12 months after therapy started by 11-NSR.	—

Countries

Germany

Contacts

Public ContactUrsula Burkard

ANFOMED GmbH

ursula.burakrd@anfomed.de09133-7762-11

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 24, 2026