Trial Outcomes & Findings for Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain (NCT NCT01384292)

Last Updated: 2015-06-01

Results Overview

Response (responder/non-responder) to study drug, where a responder was defined as having at least 3 rescue-free bowel movements (RFBMs) per week during the 4-week Part A treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks. An RFBM was defined as a bowel movement (BM) without rescue laxatives in the previous 24 hours.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

14 participants

Primary outcome timeframe

Baseline to Week 4

Results posted on

2015-06-01

Participant Flow

This multicenter study was conducted in Poland, the Czech Republic, and the United States between 29 June 2011 and 20 September 2012. Due to recruitment challenges, enrollment to this study was stopped early and no new patients had been screened as of 20 April 2012. Fourteen patients were randomized across the 3 treatment groups.

Part A was 8 weeks: 14-day screening period, 2-week OIC confirmation period, 4-week treatment period. Part B was 14 weeks: 12-week treatment period, 2-week follow-up period. Part B was optional for eligible patients completing Part A. NKTR-118 patients from Part A remained on the same NKTR-118 dose, while placebo patients received NKTR-118 25 mg.

Participant milestones

Participant milestones
Measure	NKTR-118 12.5 mg NKTR-118 12.5 mg, oral treatment	NKTR-118 25 mg NKTR-118 25 mg, oral treatment	Placebo Placebo, oral treatment
Part A STARTED	5	5	4
Part A COMPLETED	5	5	4
Part A NOT COMPLETED	0	0	0
Part B STARTED	3	6	0
Part B COMPLETED	2	6	0
Part B NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	NKTR-118 12.5 mg NKTR-118 12.5 mg, oral treatment	NKTR-118 25 mg NKTR-118 25 mg, oral treatment	Placebo Placebo, oral treatment
Part B Severe non-compliance to protocol	1	0	0

Baseline Characteristics

Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NKTR-118 12.5 mg n=5 Participants NKTR-118 12.5 mg, oral treatment	NKTR-118 25 mg n=5 Participants NKTR-118 25 mg, oral treatment	Placebo n=4 Participants Placebo, oral treatment	Total n=14 Participants Total of all reporting groups
Age, Continuous	55.8 Years STANDARD_DEVIATION 9.20 • n=93 Participants	53.8 Years STANDARD_DEVIATION 11.69 • n=4 Participants	52.5 Years STANDARD_DEVIATION 4.93 • n=27 Participants	54.1 Years STANDARD_DEVIATION 8.70 • n=483 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	4 Participants n=4 Participants	3 Participants n=27 Participants	10 Participants n=483 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	4 Participants n=483 Participants
Race/Ethnicity, Customized White	5 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	11 Participants n=483 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline to Week 4

Population: All randomized patients