A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
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|ClinicalTrials.gov Identifier: NCT00600119|
Recruitment Status : Completed
First Posted : January 24, 2008
Results First Posted : June 12, 2015
Last Update Posted : June 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Opioid Induced Constipation (OIC)||Drug: placebo Drug: NKTR-118||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Efficacy, Safety and Tolerability of NKTR-118 in Patients With Opioid-Induced Constipation (OIC)|
|Study Start Date :||December 2007|
|Primary Completion Date :||March 2009|
|Study Completion Date :||April 2009|
Placebo Comparator: A
placebo, oral, once daily (QD)
5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)
- Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1 [ Time Frame: Days 1 through 7 ]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.
- Change From Baseline in SBMs/Week Across the 28-day Double-blind Period [ Time Frame: Days 1 through 28 ]Change from baseline in SBMs/week across the 28-day double-blind period was calculated as SBMs/week during 28-day double-blind study treatment period minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period.
- Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire [ Time Frame: Days 1 through 28 ]The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely).The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) worries and concerns (11 items), 2) physical discomfort (4 items), 3) psychosocial discomfort (8 items), and 4) satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.
- Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire [ Time Frame: Days 1 through 28 ]The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600119
Show 33 Study Locations
|Study Director:||Mark Sostek||AstraZeneca Pharmaceuticals, Wilm DE|