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NCT01443403 · ClinicalTrials.gov registry record · Phase 2
A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
A Phase 2 study, sponsored by Shionogi.
- Completed
- Registry status
- Phase 2
- Development phase
- 244
- Enrollment target
NCT01443403 is a Phase 2 study that has completed, run by Shionogi. The registered enrollment target is 244 participants.
The verdict
NCT01443403, a Phase 2 study, has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 244 participants
- Enrollment target
Study Summary
The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.
Interventions
- DRUG Placebo
- DRUG Naldemedine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2011-08-17 |
| Est. Completion | 2012-08-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01443403
The ClinicalTrials.gov registry entry for NCT01443403 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 244 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shionogi, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01443403 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01443403 about?
NCT01443403 is a clinical study titled "A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy". The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.
What is the current status of trial NCT01443403?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 244 participants. The study started on 2011-08-17. Estimated completion is 2012-08-22.
What interventions are being tested in trial NCT01443403?
The interventions under investigation include: Placebo (DRUG), Naldemedine (DRUG).
Who is sponsoring clinical trial NCT01443403?
This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.
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