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Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain (SUMMIT-07)

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ClinicalTrials.gov Identifier: NCT02362672
Recruitment Status : Completed
First Posted : February 13, 2015
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics

Brief Summary:
The purpose of this study is to determine whether a new opioid molecule, NKTR-181, is effective for the relief of moderate to severe chronic low back pain as compared to a placebo.

Condition or disease Intervention/treatment Phase
Low Back Pain Chronic Pain Drug: NKTR-181 BID tablets Drug: Placebo to match NKTR-181 BID tablets Phase 3

Detailed Description:
This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-control treatment of twelve weeks. During the double-blind treatment period, this study will evaluate the analgesic effect of NKTR-181 versus placebo in patients with moderate to severe chronic low back pain.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NKTR-181 in Opioid-Naive Subjects With Moderate to Severe Chronic Low Back Pain
Actual Study Start Date : March 11, 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: NKTR-181
NKTR-181 twice daily (BID) tablets
Drug: NKTR-181 BID tablets
NKTR-181 tablets 100-400 mg twice daily (BID)

Placebo Comparator: Placebo
Placebo to match NKTR-181 twice daily (BID) tablets
Drug: Placebo to match NKTR-181 BID tablets
Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID)




Primary Outcome Measures :
  1. The Change in Weekly (ie, 7-day Average) Pain Score at the End of Double-blind, Randomized Treatment Period, Relative to the Weekly Score at the End of Titration (Double-blind Baseline) [ Time Frame: 12 Weeks of randomized double blinded period ]
    The daily pain intensity is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).


Secondary Outcome Measures :
  1. Responder Analysis Based on Percent Reduction in Pain Intensity [ Time Frame: Screening Baseline through Week 12 ]
    A responder is defined by the Sponsor as a randomized subject who completes the double-blind Randomized Treatment Period and experiences improvement in the Week 12 Weekly Pain Score from Screening Pain Score. This includes the proportion of responders with at least 30% and at least 50% reduction in pain intensity.

  2. Patient Global Impression of Change (PGIC): Number of Responders [ Time Frame: Screening Baseline through Week 12 ]
    The PGIC assesses the change in overall status relative to the initiation of the treatment. The scale measures global change of overall status on a 7-point scale (1 = No change (or condition has got worse), 2 = Almost the same, 3 = A little better, 4 = Somewhat better, 5 = Moderately better, 6 = Better, 7 = A great deal better). The proportion of subjects responding " A great deal better " and "better" was summarized by treatment group.

  3. Change in Sleep Quality in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) [ Time Frame: Screening Baseline through Week 12 ]
    The MOS Sleep Scale measure sleep parameters contains 12 items. Eleven of them scored using a 5-point response scale and across 5 dimensions of sleep, including disturbance (4 items), sleep problems index (9 items), somnolence (3 items), adequacy (2 items), and respiratory impairments (2 items). The original survey items are converted to a 0 to 100 range (by Converting 1 to 0, 2 to 25, 3 to 50, 4 to 75, and 5 to 100). Items in each dimension (disturbance, sleep problems index, somnolence, adequacy, respiratory impairments) of sleep are averaged together to create the score for the scale. The range of each sleep dimension is from 0 to 100. Higher score of sleep disturbance, somnolence, sleep indices, and respiratory impairments indicates relatively worse sleep problem, whereas lower scores for sleep adequacy indicate worse sleep problems.

  4. Change in Sleep Quantity Measure in Hours in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) [ Time Frame: Screening Baseline through Week 12 ]
    The 12 items of the MOS Sleep Scale measure sleep parameters across 6 dimensions of sleep, including disturbance (4 items), sleep problems index (9 items), quantity (1 item), somnolence (3 items), adequacy (2 items), and respiratory impairments (2 items). One of the 12 items, Sleep quantity, records the actual number of hours slept. Reported here is the sleep quantity.

  5. Change in Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Screening Baseline through Week 12 ]

    The RMDQ contains 24 items that is used to quantify the impact of low back pain on subject's ability to perform daily activities, mood and sleep. The questionnaire consists of 24 statements derived from the Sickness Impact Profile, with the addition of the phrase "because of my back." The questionnaire covers the areas of mobility, self-care, and sleeping.

    The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or non-pregnant, non-nursing female aged 18 to 75 years old
  • Clinical diagnosis of moderate to severe, chronic non-neuropathic low back pain for at least six months
  • Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics
  • Opioid analgesia is necessary
  • Currently taking no more than 10 mg morphine sulfate equivalents per day of short acting opioids for 14 days prior to entry
  • Females of child bearing potential must be using a highly effective form of birth control. All subjects must agree to use double-barrier contraception during participation in this study and for at least 2 months after the last dose of the study drug.
  • Willing and able to provide informed consent

Exclusion Criteria:

  • Taking extended release or long-acting opioids within 6 months
  • History of hypersensitivity, intolerance, or allergy to opioids
  • Compression of spinal nerve root; spinal fracture, tumor, or abscess
  • Surgical procedures on the low back in the last 12 months or facet nerve root block or radiofrequency ablation in the last 3 months
  • Untreated moderate to severe sleep apnea

Information from the National Library of Medicine

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): NCT02362672


Locations
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Sponsors and Collaborators
Nektar Therapeutics
Additional Information:
Publications of Results:
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Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT02362672    
Other Study ID Numbers: 14-181-07
First Posted: February 13, 2015    Key Record Dates
Results First Posted: September 16, 2020
Last Update Posted: September 16, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations