CompletedPhase 2/3

Study of PHN131 in Patients After Surgery

Taiwan106 participantsStarted 2013-04-30

Plain-language summary

The purpose of this study is to assess the effectiveness, safety and pharmacokinetics of Oral Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy.

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female \>= 20 years of age at Screening
✓. Scheduled to electively undergo 2 or 3-column excisional hemorrhoidectomy
✓. American Society of Anesthesiology Physical Class 1 - 3
✓. Clinical lab values twice the upper limit of normal (values of potential clinical concern are detailed in Appendix) or, if abnormal, deemed not clinically significant per the Investigator.
✓. Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.

Exclusion criteria

✕. Body weight less than 40 kg.
✕. Concurrent fissurectomy.
✕. Subject is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline.
✕. Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.
✕. History of hypersensitivity or allergy to amide-type local anesthetics, opioid, or any ingredient of the medications administered in this study.
✕. Subject has a resting respiratory rate less than 8 per minute and blood oxygen saturation less than 90 mmHg.
✕. Use of any NSAIDs, selective COX-2 inhibitors, opioid, acetaminophen, selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants (TCA), gabapentin, or pregabalin within three days of surgery.
✕. Chronic use of opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week.

What they're measuring

the area under the curve of VAS pain intensity scores

Timeframe: at 1, 2, 3, 4±0.25, 8±0.5, 12±0.5, 16±0.5, 20±0.5, 24±1, 28±1, 32±2, 36±2, 40±2, 44±2, and 48±2 h after the surgery

Trial details

NCT IDNCT02193620

SponsorPhytoHealth Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-09-21

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