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NCT00600119 · ClinicalTrials.gov registry record · Phase 2
A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 207
- Enrollment target
NCT00600119 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 207 participants.
The verdict
NCT00600119, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 207 participants
- Enrollment target
Study Summary
Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical manifestations of opioid-induced bowel dysfunction (OBD). The objective of this study is to evaluate the safety, effectiveness and pharmacokinetics of NKTR-118 at 4 different doses.
Interventions
- DRUG placebo
- DRUG NKTR-118
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00600119
The ClinicalTrials.gov registry entry for NCT00600119 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 207 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00600119 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00600119 about?
NCT00600119 is a clinical study titled "A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)". Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical manifestations of o...
What is the current status of trial NCT00600119?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 207 participants. The study started on 2007-12. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00600119?
The interventions under investigation include: placebo (DRUG), NKTR-118 (DRUG).
Who is sponsoring clinical trial NCT00600119?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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