Phase 3
N=302
A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Opioid-Induced Constipation (OIC)
Bottom Line
View on ClinicalTrials.gov: NCT01395524 ↗Enrolled (actual)
302
Serious AEs
5.8%
Results posted
Jun 2015
Primary outcome: Primary: Incidence of Patients Experiencing at Least One Adverse Event (AE) — 32; 40; 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NKTR-118 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Patients Experiencing at Least One Adverse Event (AE) |
32; 40; 33 | — |
| PRIMARY Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP) |
4; 4; 3 | — |
| PRIMARY Incidence of Patients Experiencing Severe Adverse Events (SAEs) |
6; 6; 5 | — |
| SECONDARY Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) |
-0.9; -0.9; -0.8; -0.8; -0.7; -0.7 | — |
| SECONDARY Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) |
-1.0; -0.9; -0.8; -1.0; -1.1; -1.0 | — |
Summary
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.
Eligibility Criteria
Inclusion Criteria
- Must have completed the 12-week study D3820C00004 through Visit 8.
- Provision of written informed consent prior to any study-specific procedures.
- Men and women who were between the ages of >18 and <85 years at the time of the screening visit for study D3820C00004.
- Continuing to receive a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies.
- Willingness to continue abstinence from all laxatives and other bowel regimens including prune juice and herbal products throughout this additional 12-week treatment period, and to use only bisacodyl as rescue medication if a bowel movement (BM) has not occurred within at least 72 hours of the last recorded BM.
Exclusion Criteria
- Patients receiving opioid regimen for treatment of pain related to cancer.
- History of cancer within 5 years from the screening visit of study D3820C00004 with the exception of basal cell cancer and squamous cell skin cancer.
- Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation.
- Other issues related to the gastrointestinal tract that could impose risk to the patient.
- Pregnancy or lactation.
Data sourced from ClinicalTrials.gov (NCT01395524). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.