IQP-PO-101 for the Regulation of Bowel Movement Frequency

InQpharm

Status and phase: Completed; Phase 3

Conditions: Irregular Bowel Movement Frequency; Constipation

Treatments: Device: IQP-PO-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT01809587

INQ/026612

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating the bowel movement frequency

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A subject must have experienced 2 - 4 bowel movements per week and at least 2 of the following symptoms over the preceding 3 months (self-reported):

  • Excessive straining
  • Lumpy or hard stools
  • Sensation of anorectal obstruc-tion
  • A sense of incomplete evacua-tion of bowel movements
  • A need for digital manipulation to facilitate evacuation

• Recorded between 4 and 9 defecations in the 14-day bowel movement diary during the run-in period

• Subjects of childbearing potential must agree to use appropriate contraceptive methods during run-in and treatment period

• Commitment to avoid the use of any laxatives and/ or other medicinal products/ supplements that may interfere with bowel movement frequency during the run-in and treatment period

• Written informed consent.

Exclusion criteria

• Known sensitivity to the ingredients of the device
• Any organic gastrointestinal diseases, congenital or otherwise
• Presence of occult blood on screening
• Constipation that may have been drug-induced
• Use of any laxative/ products that help ease bowel movements within 7 days of the screening visit
• Constipation other than idiopathic constipation
• Presence of other factor(s) that, in the in-vestigator's judgement, should preclude subject participation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

IQP-PO-101

Experimental group

Description:

Day 1 to Day 7 - 1 sachet to be mixed in 250ml of water and consumed twice a day Day 8 to Day 28 - 1 sachet to be mixed in 250ml of water and consumed once a day Day 28 to Day 42 - no investigational product intake (post treatment observation only)

Treatment:

Device: IQP-PO-101