open-label, single centre, observational study to evaluate the effectiveness and safety of Polyethylene Glycol 3350 in patients suffering from constipation

Open-label, prospective, non-comparative, single-centre observational study to evaluate effectiveness and tolerability of Polyethylene Glycol 3350 in the management of both Functional Constipation and Irritable Bowel Syndrome associated Constipation, in a real world setting

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/03/024222

Enrollment

Registered

2020-03-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: K590- Constipation

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients of either sex, aged 18 to 65 years 2. Patients diagnosed with constipation as per Rome IV and a decision taken to initiate treatment with polyethylene glycol 3350 3. Patients ready to provide written informed consent and comply with study procedures 4. Patient who has agreed to maintain a similar diet from the week before the start of the therapy to the end-of- 4 weeks follow-up period

Exclusion criteria

Exclusion criteria: 1. Subject with alarm symptoms of constipation such as loos of weight, loss of appetite, blood in stools, family history of colon cancer 2. Known or suspected bowel perforation, obstruction, or fecal impaction; or had gastric retention, inflammatory bowel disease, bowel resection, or colostomy 3. Known renal or hepatic insufficiency 4. Subject on psychiatric medications which can contribute to constipation 5. History of significant ongoing medical problems or scheduled for surgical procedures 6. Subjects who, in the opinion of the Investigator, should not have been included in the study for any reason, including inability to follow study procedures 7. Participated in an investigational clinical, surgical, drug or device study within the past 30 days 8. Pregnant or lactating 9. Hyper-sensitivity to PEG

Design outcomes

Primary

Measure	Time frame
1. Changes from baseline in frequency of complete spontaneous bowel movements (complete spontaneous bowel movements defined as spontaneous bowel movements associated with a sense of complete evacuation) at week 4Timepoint: Day 1, Day 7, Day 14 and Day 28	—

Secondary

Measure	Time frame
1. Change from baseline in the frequency of spontaneous bowel movements per week during the 4 weeks study period 2. Median time to first complete spontaneous bowel movement 3. Change from baseline in the stool consistency, using the Bristol stool form scale 4. Change in the symptoms of constipation, as assessed by the patientsTimepoint: Day 1, Day 7, Day 14 and Day 28	—

Countries

India

Contacts

Public ContactDr Amey Mane

Dr. Reddys Laboratories

amey.mane@drreddys.com

Outcome results