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NCT02574611
Use of High Resolution Colonic Manometry in Studying Motility
Phase 1 trial testing Neostigmine in Gastrointestinal Dysfunction. Withdrawn.
25 December 2017
Quick facts
| Lead sponsor | James J. Peters Veterans Affairs Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | single |
| Primary purpose | other |
| Start date | 13 October 2015 |
| Primary completion | 25 December 2017 |
| Estimated completion | 25 December 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Neostigmine (NEOSTIGMINE) — full drug profile →
- Glycopyrrolate — full drug profile →
- Saline (Placebo)
- High Resolution Colonic Manometry
Conditions studied
- Gastrointestinal Dysfunction — all drugs for Gastrointestinal Dysfunction →
Sponsor
James J. Peters Veterans Affairs Medical Center
Who can join
Adults 18 to 75, any sex, with Gastrointestinal Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
An injury to the spinal cord (SCI) results in numerous medical complications, including gastrointestinal (GI) function. Individuals with SCI may experience severe constipation (prolonged stool retention), incontinence (accidents), and overall difficulty in bowel evacuation. While various treatments and medications have been established to address this complication, there is little knowledge relating to the overall colonic motility. However, new technology such as High Resolution Colonic Manometry allows physicians to visualize high pressure contractions inside the colon, leading to a greater understanding of typical motility, a more accurate diagnosis, and an effective treatment. In this study, the investigators propose to use this technology to understand the effects of SCI on colonic motility by comparing to normal colonic function observed in able-bodied (AB) individuals. In addition, the investigators plan to study the effects of pharmacological treatments, such as neostigmine, on promoting peristaltic contractions in the colon as it is delivered across the skin.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02574611
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Gastrointestinal Dysfunction
Currently open trials in the same condition.
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Other James J. Peters Veterans Affairs Medical Center trials
Trials by the same sponsor.
- NCT07251491 — Psilocybin to Treat Depression in Spinal Cord Injury · Phase 1, PHASE2 · not yet recruiting
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- NCT05839652 — Treatment of Orthostatic Hypotension in SCI · Phase 4 · recruiting
- NCT05422911 — Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer. · Phase 2 · not yet recruiting
- NCT06351852 — Transdermal Administration by a Novel Wireless Iontophoresis Device · EARLY_PHASE1 · completed
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 NCT02574611 (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 James J. Peters Veterans Affairs Medical Center
- Last refreshed: 28 September 2021
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