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Osmotic Laxative

Peritoneal Dialysis Pilot Study: Evaluating Polyethylene Glycol (PEG) for Constipation

Phase 4
Waitlist Available
Led By Jaclyn Y Tran, BScPharm
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* All patients in the peritoneal dialysis program in Nova Scotia who are currently taking laxatives.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Approved for 5 Other Conditions
Drug Has Already Been Approved

Summary

Constipation is a common condition, which occurs one in four Canadians. Maintaining regular bowel movements is imperative because constipation can affect the quality of PD dialysate flow and result in an unwanted effect on the dialysis adequacy. There is limited data on how to best manage constipation in the peritoneal dialysis population. Polyethylene glycol (PEG) is an osmotic laxative that is becoming popular for prevention and treatment of constipation across Canada. Although some PD programs in Canada have already converted to PEG for management of constipation, more research in this population would help guide practice. For now, the current PD bowel regimen at the Nova Scotia Health Authority (NSHA) includes daily preventative therapy using a stimulant laxative, senna, along with an osmotic laxative, lactulose, for acute constipation. The investigators will review all patients in the NSHA PD program who have regular or recent laxative use for participation in this study. Patients included in this study will be randomly assigned to the Current Bowel Protocol or the PEG Bowel Protocol for 8 weeks. The goal is to determine if the PEG Bowel Protocol is as effective and safe for the prevention of constipation as the Current Bowel Protocol used in the PD Program. The investigators will use bowel function diaries and patient surveys to determine efficacy and safety outcomes.

Eligible Conditions
  • Constipation
  • Peritoneal Dialysis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of constipation treatment success
Secondary study objectives
Incidence of peritoneal dialysis treatment failure requiring intervention
Mean change from baseline on the PAC-QOL questionnaire
Mean change from baseline on the PAC-SYM questionnaire
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Group I: Current Bowel ProtocolActive Control1 Intervention
Patients will receive the Current Bowel Protocol with senna. Lactulose will be used for rescue therapy.
Group II: PEG Bowel ProtocolActive Control1 Intervention
Patients will receive the Protocol with Polyethylene Glycol 3350. Lactulose will be used for rescue therapy.

Find a Location

Who is running the clinical trial?

Nova Scotia Health AuthorityLead Sponsor
288 Previous Clinical Trials
94,537 Total Patients Enrolled
Jaclyn TranLead Sponsor
Jaclyn Y Tran, BScPharmPrincipal InvestigatorNova Scotia Health Authority
~3 spots leftby Jan 2026