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

Primary Purpose

Low Back Pain, Chronic Pain

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

NKTR-181 BID tablets

Placebo to match NKTR-181 BID tablets

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NKTR-181

Placebo

Arm Description

NKTR-181 twice daily (BID) tablets

Placebo to match NKTR-181 twice daily (BID) tablets

Outcomes

Primary Outcome Measures

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)

The daily pain intensity is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).

Secondary Outcome Measures

Responder Analysis Based on Percent Reduction in Pain Intensity

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

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)

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)

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)

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.

Full Information

NCT ID

NCT02362672

First Posted

February 9, 2015

Last Updated

September 14, 2020

Sponsor

Nektar Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT02362672

Brief Title

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

Acronym

SUMMIT-07

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

March 11, 2015 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nektar Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain, Chronic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1189 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NKTR-181

Arm Type

Experimental

Arm Description

NKTR-181 twice daily (BID) tablets

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo to match NKTR-181 twice daily (BID) tablets

Intervention Type

Drug

Intervention Name(s)

NKTR-181 BID tablets

Intervention Description

NKTR-181 tablets 100-400 mg twice daily (BID)

Intervention Type

Drug

Intervention Name(s)

Placebo to match NKTR-181 BID tablets

Intervention Description

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

Primary Outcome Measure Information:

Title

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)

Description

The daily pain intensity is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).

Time Frame

12 Weeks of randomized double blinded period

Secondary Outcome Measure Information:

Title

Responder Analysis Based on Percent Reduction in Pain Intensity

Description

Time Frame