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NCT01928953 · ClinicalTrials.gov registry record
Longitudinal Study of Patients With Opioid-Induced Constipation
A clinical trial, sponsored by AstraZeneca.
- Completed
- Registry status
- 520
- Enrollment target
NCT01928953: Completed study, sponsored by AstraZeneca.
NCT01928953 is a clinical trial that has completed, run by AstraZeneca. The registered enrollment target is 520 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01928953 has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- 520 participants
- Enrollment target
Study Summary
This prospective hybrid longitudinal study was conducted in the United States (US), Canada, the United Kingdom (UK), and Germany. To obtain the most complete and comprehensive understanding of the burden of opioid-induced constipation (OIC) in these countries, this study used a combination of web-based, longitudinal patient survey, retrospective data abstraction from medical records, and a prospective physician survey. The primary objective of this study was to estimate the rate of inadequate response to laxatives (LIR), which was defined as having sufficient laxative use (at least one laxative use ≥ four times per reference period), and inadequate response (defined as fewer than three bowel movements (BMs) OR at least one of the following symptoms on the Patient Assessment of Constipation Symptoms (PAC-SYM) measure scored as moderate, severe or very severe: BMs too hard, straining to have a BM, feeling like you didn't "finish" a BM, and feeling like you had to pass a BM but could not), in a cohort of non-cancer pain and cancer pain (separately) participants with OIC, by country and overall. The secondary study objectives are as follows: 1. To estimate the rate of LIR for two subgroups: 1xLIR and 2xLIR. 1xLIR was defined as use of at least one laxative agent ≥ 4 times in the reference period while 2xLIR was defined as the use of at least two laxative agents, each used ≥ 4 times in the reference period; 2. To describe the baseline demographic and clinical characteristics, including prior health status, comorbidities, constipation-related GI symptoms, and concomitant medications of patients with OIC; 3. To describe drug utilization and self-management of OIC; 4. To describe the pre-index and post-index healthcare resource utilization and estimate costs associated with the diagnosis, treatment, and general management of OIC (including laxative use) and events attributed to OIC, including both direct and indirect costs; 5. To describe patient-reported impact of OIC o
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 520 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-12 |
What the finished NCT01928953 record still lists
NCT01928953 is an observational study that tracks outcomes without assigning an intervention. The registered 520 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01928953 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01928953 about?
NCT01928953 is a clinical study titled "Longitudinal Study of Patients With Opioid-Induced Constipation". This prospective hybrid longitudinal study was conducted in the United States (US), Canada, the United Kingdom (UK), and Germany. To obtain the most complete and comprehensive understanding of the burden of opioid-induced constipation (OIC) in these countries, this study used a combination of web-ba...
What is the current status of trial NCT01928953?
This trial is currently completed. The enrollment target is 520 participants. The study started on 2012-10. Estimated completion is 2014-12.
Who is sponsoring clinical trial NCT01928953?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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