RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: testing The pregabalin group for Irritable Bowel Syndrome (IBS)

To explore the how well it works of pregabalin for patients with irritable bowel syndrome (IBS).

Official registry: https://clinicaltrials.gov/study/NCT07635394 · Beijing Tiantan Hospital · enrollment listed as 258

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are The pregabalin group, or Routine Treatment. The registry lists allocation as randomized. To explore the how well it works of pregabalin for patients with irritable bowel syndrome (IBS).

They plan to enroll about 258 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Efficacy and Safety of Pregabalin in Patients With Irritable Bowel Syndrome : A Multi-center Prospective Randomized Open Blinded End-point Trial

Interventions: The pregabalin group, Routine Treatment

Primary outcome (registry wording): The IBS Severity Scoring System (IBS-SSS) and respnse rate

Who it is for (from inclusion criteria)

Ages 18 Years to 70 Years
Age range: 18-70 years old;
According to the Rome IV diagnostic criteria for IBS, the screening result is positive;
Mild to moderate IBS patients assessed based on the IBS-SSS

Who the registry excludes

Concurrent gastrointestinal conditions presenting with symptoms potentially overlapping with those of IBS, significant medical comorbidities;
Severe mental disorders associated with marked personality disturbances, active suicidal thoughts or any self harm episodes within the preceding 12 months;
Current or intended pregnancy or lactation;
Cognitive impairment;
Recent use of pregabalin (within 30 days) or known allergy to pregabalin;
Use of IBS specific agents such as alosetron;
Consumption exceeding 50 units of alcohol weekly (where 1 unit corresponds to 10 mL of pure alcohol)

Public study contact (from the registry)

Fang Luo

+86 13611326978

13611326978@163.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (recruiting)

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FAQ about this NCT record

Is NCT07635394 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07635394?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07635394?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary