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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: Completed Phase 2 study, sponsored by AstraZeneca.
NCT00600119 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 207 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from baseline in SBMs/week during Week 1 was defined as SBMs/week during the first week of double-blind study medication (between Visit 4 and Visit 6) minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period. An SBM was defined as a BM without the use of laxatives in the previous 24 hours as recorded in the e-diary.
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 |
What the finished NCT00600119 record still lists
NCT00600119 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00600119 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00600119's enrollment target sits among peer trials
207 297th of 2000 higher than 1,703 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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