A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery

NCT00718081 | Completed Phase 2 Results

• 1 other identifier: ARX-C-005
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate dosages of ARX-F01 (opioid pain medication) versus a placebo (or sugar pill) for the treatment of post-operative pain in subjects following abdominal surgery. We hypothesize that subjects receiving placebo will have poor pain relief and will drop out of the study sooner and more often than the ARX-F01 treated subjects.

Conditions

Major Upper or Lower Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• SPID-12

  The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The scores after summing could range from -122 to +122. A higher SPID-12 score is better.

  12 hours after surgery

Secondary Outcomes (1)

• Proportion of Patients Who Responded Very Good or Excellent in Patient Global Evaluation of Pain Relief

  Up to 12 hours after surgery

Study Arms (3)

1

EXPERIMENTAL

Oral Sufentanil

Drug: Oral sufentanil

2

EXPERIMENTAL

Oral sufentanil

Drug: Oral sufentanil

3

PLACEBO COMPARATOR

Oral dosage of placebo

Drug: Placebo

Interventions

Oral sufentanil DRUG

Oral dosage of sufentanil

1; 2

Placebo DRUG

Oral dosage of placebo

3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients between 18 to 80 years of age.
• Patient is scheduled to undergo an upper or lower abdominal surgery under general anesthesia.
• Patient must be classified as American Society of Anesthesiologists (ASA) class I - III.
• Patient must have Body Mass Index \[BMI = weight (kg)/height (m2)\] between 18 and 39, inclusively.
• Female patients of childbearing potential must be using an effective method of birth control from the screening visit through the end of study. Acceptable methods of birth control include oral or transdermal contraceptives, condom, spermicidal foam, intrauterine device (IUD), progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-childbearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or postmenopausal for ≥1 year, must be specified in the patient's case report form (CRF).
• The patient must be willing and able to understand the study procedures and the use of pain scales, and to communicate meaningfully with the study personnel.
• The patient must provide written informed consent and sign the Informed Consent

You may not qualify if:

• Patient is scheduled to undergo a laparoscopically-assisted abdominal surgery.
• Patient has previously not responded to opioid analgesics for treatment of pain.
• Patient is currently taking or has taken an opioid for more than 30 consecutive days of daily use at a daily dose equivalent to greater than 15 mg morphine within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
• Patient has an allergy or hypersensitivity to opioids.
• Patient currently has sleep apnea that has been documented by a sleep laboratory study.
• Patient has any screening laboratory test value outside the laboratory normal range which is considered clinically significant by the Investigator.
• Patient is a woman who is pregnant or lactating.
• Patient has psychiatric disease or encephalopathy severe enough to prevent patient from providing reliable study documentation.
• Patient, in the Investigator's judgment, does not have adequate ability to read and understand English.
• Patient has a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including chronic abdominal pain or active infection.
• Patient has clinically significant renal or liver impairment which could affect metabolism or clearance of sufentanil.
• Patient has a painful physical condition other than acute abdominal pain that, in the opinion of the Investigator, may confound post-operative pain assessments.
• Patient has a history of drug, prescription medicine, or alcohol abuse within the past 2 years or a positive drug screen test for cocaine, amphetamines, barbiturates, phencyclidine, or methadone at screening.
• Patient is receiving oxygen therapy at the time of screening.
• Patient has participated in a clinical trial of an investigational drug or device within 30 days of screening visit or is scheduled to receive an investigational product other than ARX-F01 while participating in this study.

Sponsors & Collaborators

• Talphera, Inc: lead

Study Sites (1)

Trio Clinical Research

Durham, North Carolina, 27713, United States

Location

Related Publications (1)

• Minkowitz HS, Singla NK, Evashenk MA, Hwang SS, Chiang YK, Hamel LG, Palmer PP. Pharmacokinetics of sublingual sufentanil tablets and efficacy and safety in the management of postoperative pain. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):131-9. doi: 10.1097/AAP.0b013e3182791157.

  PMID: 23271030 RESULT

MeSH Terms

Interventions

Sufentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Pamela Palmer
• Organization: AcelRx

ppalmer@acelrx.com

650-216-3500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 18, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: January 22, 2015
• Results First Posted: January 22, 2015

Record last verified: 2014-12

Locations

US (1)