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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

Tracking Information
First Submitted Date  ICMJE February 9, 2015
First Posted Date  ICMJE February 13, 2015
Results First Submitted Date  ICMJE December 19, 2019
Results First Posted Date  ICMJE September 16, 2020
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE March 11, 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2020)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2015)
  • Change in Pain [ Time Frame: 12 Weeks ]
    Change in Pain Scores from baseline to Week 12 of treatment period
  • Improvement in Pain [ Time Frame: 12 Weeks ]
    Percentage of Subjects with a greater than or equal to 30% improvement in pain scores
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Low Back Pain
  • Chronic Pain
Intervention  ICMJE
  • Drug: NKTR-181 BID tablets
    NKTR-181 tablets 100-400 mg twice daily (BID)
  • Drug: Placebo to match NKTR-181 BID tablets
    Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID)
Study Arms  ICMJE
  • Experimental: NKTR-181
    NKTR-181 twice daily (BID) tablets
    Intervention: Drug: NKTR-181 BID tablets
  • Placebo Comparator: Placebo
    Placebo to match NKTR-181 twice daily (BID) tablets
    Intervention: Drug: Placebo to match NKTR-181 BID tablets
Publications * Markman J, Gudin J, Rauck R, Argoff C, Rowbotham M, Agaiby E, Gimbel J, Katz N, Doberstein SK, Tagliaferri M, Lu L, Siddhanti S, Hale M. SUMMIT-07: a randomized trial of NKTR-181, a new molecular entity, full mu-opioid receptor agonist for chronic low-back pain. Pain. 2019 Jun;160(6):1374-1382. doi: 10.1097/j.pain.0000000000001517.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2020)
1189
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2015)
416
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02362672
Other Study ID Numbers  ICMJE 14-181-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nektar Therapeutics
Study Sponsor  ICMJE Nektar Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nektar Therapeutics
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP