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Sponsored by: |
AcelRx Pharmaceuticals, Inc. |
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Information provided by: | AcelRx Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00718081 |
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.
Condition | Intervention | Phase |
---|---|---|
Major Upper or Lower Abdominal Surgery |
Drug: Oral sufentanil Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment |
Official Title: | A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 in Patients Undergoing Major Abdominal Surgery |
Estimated Enrollment: | 72 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Oral Sufentanil
|
Drug: Oral sufentanil
Oral dosage of sufentanil
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2: Experimental
Oral sufentanil
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Drug: Oral sufentanil
Oral dosage of sufentanil
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3: Placebo Comparator
Oral dosage of placebo
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Drug: Placebo
Oral dosage of placebo
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria at Screening:
Exclusion Criteria at Screening:
Exclusion Criteria at Randomization (during early PACU time period):
approved by the Institutional Review Board (IRB).
Contact: Peggy Gratta | 866-550-6367 | |
Contact: Jennifer Siddle | 919-401-1800 ext 4054 |
United States, North Carolina | |
Trio Clinical Research | Recruiting |
Durham, North Carolina, United States, 27713 |
Responsible Party: | AcelRx Pharmaceuticals, Inc. ( Pam Palmer, MD, PhD ) |
Study ID Numbers: | ARX-C-005 |
Study First Received: | July 16, 2008 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00718081 |
Health Authority: | United States: Food and Drug Administration |
Sufentanil |
Anesthetics, Intravenous Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Pharmacologic Actions Adjuvants, Anesthesia |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |