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NCT01691742 · ClinicalTrials.gov registry record · NA
MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 131
- Enrollment target
NCT01691742 is a NA study that has completed, run by Duke University. The registered enrollment target is 131 participants.
The verdict
NCT01691742, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 131 participants
- Enrollment target
Study Summary
A. Purpose To compare MiraLAX versus placebo for preventing constipation in the immediate postoperative period following pelvic reconstructive surgery in women taking routine docusate sodium. B. Objectives 1. Specific Aims Specific Aim 1: To compare time to first bowel movement (BM) between MiraLAX versus placebo in women receiving routine docusate sodium after pelvic reconstructive surgery. Specific Aim 2: To compare patient reported outcomes of BM quality and associated gastrointestinal (GI) symptoms between MiraLAX versus placebo using the Bristol stool scale and the validated Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) in women receiving routine docusate sodium after pelvic reconstructive surgery. Specific Aim 3: To evaluate GI-related quality of life between MiraLAX versus placebo utilizing the validated Patient Assessment of Constipation Quality-of-Life Questionnaire (PAC-QOL) in women receiving routine docusate sodium after pelvic reconstructive surgery. 2. Hypotheses The investigators hypothesize that MiraLAX will optimally prevent constipation following pelvic reconstructive surgery by decreasing time to first BM, decreasing GI symptoms associated with constipation, and increasing measures of GI-related quality of life, while minimizing the bothersome side effects associated with stimulant laxatives.
Interventions
- DRUG Placebo
- DRUG MiraLax
- DRUG Rescue Laxative
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01691742
The ClinicalTrials.gov registry entry for NCT01691742 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01691742 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01691742 about?
NCT01691742 is a clinical study titled "MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery". A. Purpose To compare MiraLAX versus placebo for preventing constipation in the immediate postoperative period following pelvic reconstructive surgery in women taking routine docusate sodium. B. Objectives 1. Specific Aims Specific Aim 1: To compare time to first bowel movement (BM) between MiraLA...
What is the current status of trial NCT01691742?
This trial is currently completed. It is a NA study. The enrollment target is 131 participants. The study started on 2012-09. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01691742?
The interventions under investigation include: Placebo (DRUG), MiraLax (DRUG), Rescue Laxative (DRUG).
Who is sponsoring clinical trial NCT01691742?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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