NCT02662764

Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg

Completed Phase 3 Results posted Last updated 8 August 2018

What this trial tests

Phase 3 trial testing Zalviso™ 15 mcg in Moderate-to-severe Acute Pain in 320 participants. Completed in 5 May 2017.

Timeline

28 September 2016

Primary endpoint
14 April 2017

5 May 2017

Quick facts

Lead sponsor	Talphera, Inc
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	320
Start date	28 September 2016
Primary completion	14 April 2017
Estimated completion	5 May 2017
Sites	11 locations across United States

Drugs / interventions tested

• Zalviso™ 15 mcg — full drug profile →

Conditions studied

• Moderate-to-severe Acute Pain — all drugs for Moderate-to-severe Acute Pain →

Sponsor

Talphera, Inc — full company profile →

Who can join

18 and older, any sex, with Moderate-to-severe Acute Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System Primary · Up to 72 hours

Group	Value	95% CI
Zalviso™ 15 mcg	2.2

Percentage of Patients, if Any, With Tablets Dispensed But Not Requested Primary · Up to 72 hours

Group	Value	95% CI
Zalviso™ 15 mcg	0

Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout Primary · Up to 72 hours

Group	Value	95% CI
Zalviso™ 15 mcg	0

Percentage of Patients With Misplaced Tablet(s) Primary · Up to 72 hours

Group	Value	95% CI
Zalviso™ 15 mcg	3.8

Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth) Primary · Up to 24 hours

Group	Value	95% CI
Zalviso™ 15 mcg	13

Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet (i.e., a Dispense Failure) Primary · Up to 72 hours

Group	Value	95% CI
Zalviso™ 15 mcg	5.6

Number of Zalviso System Notifications to the Nurse to Retrain Patient to Not Pull Down on the Controller While Dosing Primary · Up to 72 hours

Group	Value	95% CI
Zalviso™ 15 mcg	0

Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System Primary · Up to 72 hours

Group	Value	95% CI
Zalviso™ 15 mcg	2.2

Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet That Caused an Analgesic Gap Primary · Up to 72 hours

Group	Value	95% CI
Zalviso™ 15 mcg	2.8

Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 24 Hours as "Good" or "Excellent" Primary · Up to 24 hours

Group	Value	95% CI
Zalviso™ 15 mcg	86.1

Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 48 Hours as "Good" or "Excellent" Primary · Up to 48 hours

Group	Value	95% CI
Zalviso™ 15 mcg	88.5

Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 72 Hours as "Good" or "Excellent" Primary · Up to 72 hours

Group	Value	95% CI
Zalviso™ 15 mcg	100

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Zalviso™ 15 mcg

Serious: 3/320 (1%)

Deaths: 0/320

Serious adverse events (8 terms)

Reaction	System	Zalviso™ 15 mcg
Anaemia	Blood and lymphatic system disorders	—
Cardiac Failure Chronic	Cardiac disorders	—
Pyrexia	General disorders	—
Renal Injury	Injury, poisoning and procedural complications	—
Sedation	Nervous system disorders	—
Hypotension	Vascular disorders	—
Labile blood pressure	Vascular disorders	—
Chronic renal failure	Renal and urinary disorders	—

Other adverse events (14 terms — click to expand)

Reaction	System	Zalviso™ 15 mcg
Nausea	Gastrointestinal disorders	—
Hypotension	Vascular disorders	—
Vomiting	Gastrointestinal disorders	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—
Oxygen saturation decreased	Investigations	—
Bradycardia	Cardiac disorders	—
Hypokalaemia	Metabolism and nutrition disorders	—
Dizziness	Nervous system disorders	—
Headache	Nervous system disorders	—
Pruritis	Skin and subcutaneous tissue disorders	—
Pyrexia	General disorders	—
Tachycardia	Cardiac disorders	—
Constipation	Gastrointestinal disorders	—
Hypertension	Vascular disorders	—

Most-reported serious reactions: Anaemia, Cardiac Failure Chronic, Pyrexia, Renal Injury, Sedation, Hypotension, Labile blood pressure, Chronic renal failure.

Data from ClinicalTrials.gov NCT02662764 adverse events section.

Sponsor's own description

Study to evaluate the overall performance of the Zalviso System™ (sufentanil sublingual tablet system) 15 mcg

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.