CompletedPhase 4

Pain Relief In Irritable Bowel Syndrome

Italy30 participantsStarted 2015-01

Plain-language summary

The purpose of this study is to determine whether Proklama is effective in significative reduction of pain, other symptoms IBS's related, and improves quality of life concerning IBS disease.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. patients over 18 y.o.
✓. clinical diagnosis of IBS following Rome III symptom- based criteria:
✓. abdominal pain or discomfort recurring for at least 3 days a month in the previous 3 months, associated with 2 of the following characteristics at least: improved with evacuation; onset associated with variation of stool frequency; onset associated with changes in stool consistency
✓. onset of symptomatology at least 6 months preceding diagnosis
✓. additional criterion: mean severity of abdominal pain higher than 3 in the 11-points NRS
✓. For patients over 50 y.o. or with positive familiarity for colorectal cancer: normal colonoscopy performed within 5 years from the beginning of the screening's period and after symptomatology's onset
✓. For patients over 65 y.o. : absence of ischemic / microscopic colitis, or other organic gastrointestinal disorders, as highlighted through colonoscopy with biopsy performed within 6 months from the beginning of the screening's period
✓. For fertile and sexually active women: use of effective contraception with failure rate of less than 1% for one year during the trial period and 30 days after its end.

Exclusion criteria

✕. Male gender
✕. Patient has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS according to the Rome III criteria
✕. Patient has had surgery that meets any of the following criteria:
✕. Patient has any elective major surgery planned or expected at any time during the study.
✕. Patient has a history of inflammation bowel diseases, complicated diverticulosis ( i.e. diverticulitis), ischaemic colitis, microscopic colitis.
✕. Patient has a history of organic abnormalities of the GI tract, intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, adhesions or impaired intestinal circulation ( e.g., aortoiliac disease).
✕. Patient has a history of pancreatitis of any etiology, cholecystitis or of symptomatic gallbladder stone disease in the previous 6 months.
✕. Patient has an active biliary duct disease of a history of Sphincter of Oddi dysfunction.

What they're measuring

Recorded pain in a diary using a 11-points Numeric Rating Scale (NRS)

Timeframe: 24 h

Trial details

NCT IDNCT02573844

SponsorGeophyt S.r.l.s.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10

View on ClinicalTrials.gov More Irritable Bowel Syndrome trials