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

This study has been terminated.
(The study was stopped early due to recruitment challenges)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01384292
First received: June 28, 2011
Last updated: May 28, 2015
Last verified: May 2015
Results First Received: October 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Opioid-Induced Constipation
Interventions: Drug: NKTR-118
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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

Participant Flow for 2 periods

Period 1:   Part A
    NKTR-118 12.5 mg     NKTR-118 25 mg     Placebo  
STARTED     5     5     4  
COMPLETED     5     5     4  
NOT COMPLETED     0     0     0  

Period 2:   Part B
    NKTR-118 12.5 mg     NKTR-118 25 mg     Placebo  
STARTED     3     6     0  
COMPLETED     2     6     0  
NOT COMPLETED     1     0     0  
Severe non-compliance to protocol                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    NKTR-118 12.5 mg     NKTR-118 25 mg     Placebo     Total  
Number of Participants  
[units: participants]
  5     5     4     14  
Age  
[units: Years]
Mean (Standard Deviation)
  55.8  (9.20)     53.8  (11.69)     52.5  (4.93)     54.1  (8.70)  
Gender  
[units: Participants]
       
Female     3     4     3     10  
Male     2     1     1     4  
Race/Ethnicity, Customized  
[units: Participants]
       
White     5     3     3     11  
Black or African American     0     2     1     3  



  Outcome Measures

1.  Primary:   Response (Responder/Non-responder) to Study Drug   [ Time Frame: Baseline to Week 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to recruitment challenges, enrollment was stopped early. 14 patients were randomized (<5% of planned number), thus, there was insufficient data to perform the protocol-specified statistical analyses. Secondary outcome measures are not reported.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01384292     History of Changes
Other Study ID Numbers: D3820C00006
2011-001985-16
Study First Received: June 28, 2011
Results First Received: October 13, 2014
Last Updated: May 28, 2015
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Slovakia: State Institute for Drug Control
South Africa: Medicine Control Council
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Romania: National Medicines Agency (ANM)
Poland: Ministry of Health and Social Welfare
Croatia: Agency for Medicinal Product and Medical Devices