Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
18–84
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
