Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT02276768
Status:
COMPLETED
Last Update Posted:
2016-08-10
First Post:
2014-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Analgesia of GIC-1001 & GIC-1002 on Visceral Pain, Rectal Sensory Threshold Using the Barostat Method
Sponsor:
gicare Pharma Inc.
Organization:
Study Overview
Official Title:
A Phase 1b Clinical Study on the Analgesic Effect of GIC-1001 and GIC-1002 on Visceral Pain Under Rectal Distension and Rectal Sensory Threshold Using the Barostat Method in Male and Female Healthy Volunteers.
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates colonic analgesia by comparing two novel formulations, GIC-1001 and GIC-1002 with placebo using a barostat distender. The healthy male and female volunteers randomized to one of 5 possible treatments will be exposed to rectal distension following a 3-day treatment TID. The barostat methodology is a well-established and validated way to assess visceral pain. Visceral pain will be evaluated during exposure to varying distender pressures using a visual analog scale.
Detailed Description:
The objectives of this single center, randomized, double-blinded, placebo-controlled Phase I clinical study include the evaluation of visceral pain intensity under rectal distension following the oral administration of either of two doses of GIC-1001 or of either of two doses of GIC-1002, equimolar to the first formulation, or of placebo in 90 healthy subjects.
The barostat intra-balloon pressure required to elicit pre-defined rectal sensory symptoms (i.e. first sensation, need to defecate, urgency to defecate and pain) will also be determined. Rectal sensory symptom ratings and rectal compliance under increased rectal distension will also be evaluated.
The contribution of hydrogen sulphide (H2S) to the colonic analgesic activity of GIC-1001 by comparison to that of GIC-1002 will be evaluated following steady state pharmacokinetic analysis. To further comprehend the non-linear, U shape dose response curve observed with GIC-1001 in a previous Phase II a trial.
Finally, the safety of GIC-1002 in healthy volunteers will also be evaluated.
The barostat intra-balloon pressure required to elicit pre-defined rectal sensory symptoms (i.e. first sensation, need to defecate, urgency to defecate and pain) will also be determined. Rectal sensory symptom ratings and rectal compliance under increased rectal distension will also be evaluated.
The contribution of hydrogen sulphide (H2S) to the colonic analgesic activity of GIC-1001 by comparison to that of GIC-1002 will be evaluated following steady state pharmacokinetic analysis. To further comprehend the non-linear, U shape dose response curve observed with GIC-1001 in a previous Phase II a trial.
Finally, the safety of GIC-1002 in healthy volunteers will also be evaluated.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| GCR-P7-403 | OTHER | Algorithme Pharma Inc. | View |