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NCT03682367
Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery
Phase 3 trial testing Gabapentin in Cancer of Head and Neck in 8 participants. Terminated before completion.
1 April 2020
Quick facts
| Lead sponsor | University of California, Davis |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 8 |
| Start date | 1 December 2018 |
| Primary completion | 1 April 2020 |
| Estimated completion | 6 April 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Gabapentin (Gabapentin) — full drug profile →
- Placebo - Concentrate — full drug profile →
Conditions studied
- Cancer of Head and Neck — all drugs for Cancer of Head and Neck →
- Narcotic Use — all drugs for Narcotic Use →
Sponsor
University of California, Davis
Who can join
18 and older, any sex, with Cancer of Head and Neck or Narcotic Use. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Other adverse events (2 terms — click to expand)
| Reaction | System | Control | Intervention |
|---|---|---|---|
| Constipation | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
Data from ClinicalTrials.gov NCT03682367 adverse events section.
Sponsor's own description
Patients undergoing head and neck cancer surgery often have a lot of pain after surgery, which can lead to a need for a lot of narcotic pain medication. These medications can have many side effects that can make recovery more difficult including nausea, vomiting, dizziness, being overly sleepy, itchiness, inability to urinate, confusion, inability to have a bowel movement, longer time before being able to start walking. These side effects can make the hospital stay longer. The use of gabapentin, which is a non narcotic pain medication that focuses on nerve pain, has been used in smaller head and neck surgeries including removal of tonsils, sinus surgery, thyroid surgery. Studies in patients needing orthopedic or OB/Gyn surgery have shown improved pain control with gabapentin. Potential benefits to future patients include improved pain control, less narcotic associated side effects and faster functional recovery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03682367
- Europe PMC full search
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Related trials
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Trials testing the same drug.
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- NCT04613024 — Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty · EARLY_PHASE1 · withdrawn
- NCT07389551 — Comparison of Pregabalin Versus Gabapentin as Pre-emptive Analgesic · NA · completed
- NCT06992427 — High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Che · Phase 3 · recruiting
Other recruiting trials for Cancer of Head and Neck
Currently open trials in the same condition.
- NCT04258813 — Onco-primary Care Networking to Support TEAM-based Care · NA · active not recruiting
- NCT05179824 — Tempus Priority Study: A Pan-tumor Observational Study · active not recruiting
- NCT03383094 — Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer · Phase 2 · active not recruiting
Other University of California, Davis trials
Trials by the same sponsor.
- NCT07024498 — Coordinating Outpatient bupreNorphiNe for Emergency Care and Continuing Treatment · NA · not yet recruiting
- NCT07322133 — Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE) · Phase 4 · recruiting
- NCT07384767 — Efficacy and Safety of Topical Timolol in Secondary Intention Surgical Wounds Healing · Phase 2 · not yet recruiting
- NCT07267494 — Image-Guided Herniorrhaphy Study · NA · not yet recruiting
- NCT04614714 — Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants · Phase 2, PHASE3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03682367 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, Davis
- Last refreshed: 9 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03682367.
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