oxybutynin and Headache studies

oxybutynin: RN given refers to parent cpd
oxybutynin : A racemate comprising equimolar amounts of (R)-oxybutynin and esoxybutynin. An antispasmodic used for the treatment of overactive bladder.

Headache: The symptom of PAIN in the cranial region. It may be an isolated benign occurrence or manifestation of a wide variety of HEADACHE DISORDERS.

Research Excerpts

Excerpt	Relevance	Reference
"This will be an open-label randomized, controlled trial conducted at Women's College Hospital comparing five formulations of nitrates for their effects on bone turnover markers and headache."	5.17	Nitrates and bone turnover (NABT) - trial to select the best nitrate preparation: study protocol for a randomized controlled trial. ( Bucur, RC; Cummings, SR; Hamilton, CJ; Jamal, SA; Reid, LS, 2013)
" Extended-release formulations of oxybutynin at 10 mg/d or tolterodine at 4 mg/d were given for 12 weeks to women with 21 to 60 urge urinary incontinence (UUI) episodes per week and an average of 10 or more voids per 24 hours."	5.10	Prospective, randomized, double-blind study of the efficacy and tolerability of the extended-release formulations of oxybutynin and tolterodine for overactive bladder: results of the OPERA trial. ( Appell, RA; Diokno, AC; Dmochowski, RR; Gburek, BM; Kell, SH; Klimberg, IW; Sand, PK, 2003)
" The objective of the present study was to determine the pharmacokinetic characteristics and tolerability of rotigotine transdermal patch after repeated-dose application in healthy male and female Korean subjects."	2.80	Pharmacokinetic properties and tolerability of rotigotine transdermal patch after repeated-dose application in healthy korean volunteers. ( Andreas, JO; Braun, M; Cawello, W; Elshoff, JP; Jang, IJ; Kim, BH; Kim, JR; Soo Lim, K; Yu, KS, 2015)
" This study determined whether application of the AP to three different anatomical sites (lower abdomen, buttock and upper torso) influences the pharmacokinetic profile of EE and levonorgestrel (LNG)."	2.78	Therapeutically equivalent pharmacokinetic profile across three application sites for AG200-15, a novel low-estrogen dose contraceptive patch. ( Archer, DF; Foegh, M; Rubin, A; Stanczyk, FZ, 2013)
" Primary safety outcomes included occurrence of adverse events and dropouts."	2.76	Long-term safety and efficacy of rotigotine transdermal patch for moderate-to-severe idiopathic restless legs syndrome: a 5-year open-label extension study. ( Beneš, H; Ferini-Strambi, L; Fichtner, A; García-Borreguero, D; Högl, B; Kohnen, R; Oertel, W; Poewe, W; Schollmayer, E; Stiasny-Kolster, K; Trenkwalder, C, 2011)
" Saliva output was measured objectively before dosing with each treatment and at 0."	2.70	A comparison of the effects on saliva output of oxybutynin chloride and tolterodine tartrate. ( Appell, RA; Chancellor, MB; Gupta, SK; Sathyan, G, 2001)
" The maximum steady-state drug concentration and area under the concentration curve from time 0 on day 5 (t = 0) to the 24-hours sample on day 6 were 514 ng/mL (95% CI 439 to 603 ng/mL) and 9."	1.48	A Pharmacokinetic Study of an Ibuprofen Topical Patch in Healthy Male and Female Adult Volunteers. ( Bhatt, A; Connolly, MP; Lewis, F, 2018)

Research

Studies (11)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Bone Turnover Markers

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	4 (36.36)	29.6817
2010's	7 (63.64)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Diokno, AC	1
Appell, RA	2
Sand, PK	1
Dmochowski, RR	1
Gburek, BM	1
Klimberg, IW	1
Kell, SH	1
Reiz, JL	1
Salem, P	1
Darke, AC	1
Chancellor, MB	1
Sathyan, G	1
Gupta, SK	1
Zhou, W	1
Lv, C	1
Zhang, Q	1
Zong, S	1
Wang, M	1
Lewis, F	1
Connolly, MP	1
Bhatt, A	1
Bucur, RC	1
Reid, LS	1
Hamilton, CJ	1
Cummings, SR	1
Jamal, SA	1
Kim, BH	1
Yu, KS	1
Jang, IJ	1
Soo Lim, K	1
Kim, JR	1
Elshoff, JP	1
Andreas, JO	1
Braun, M	1
Cawello, W	1
Oertel, W	1
Trenkwalder, C	1
Beneš, H	1
Ferini-Strambi, L	1
Högl, B	1
Poewe, W	1
Stiasny-Kolster, K	1
Fichtner, A	1
Schollmayer, E	1
Kohnen, R	1
García-Borreguero, D	1
Rapoport, AM	1
Stanczyk, FZ	1
Archer, DF	1
Rubin, A	1
Foegh, M	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Comparison of the Efficacy and Tolerability of DITROPAN XL and DETROL LA in the Treatment of Overactive Bladder[NCT00293839]	Phase 3	790 participants (Actual)	Interventional		Completed
Nitrates and Bone Turnover (NABT): Trial to Select the Best Nitrate Preparation[NCT01387672]	Phase 3	265 participants (Actual)	Interventional	2011-09-30	Completed
A Single-site, Randomized, Double-blind, Placebo-controlled, Repeated-dose Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in 2 Different Dosages (2 mg / 24 Hours [10 cm2], 4 mg / 24 Hours [20 cm2]) in Healthy Korean Subject[NCT01964573]	Phase 1	48 participants (Actual)	Interventional	2006-12-31	Completed
An Open-label Extension Trial to Determine Safety and Tolerability of Long-term Transdermal Application of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome[NCT00498186]	Phase 2	295 participants (Actual)	Interventional	2003-07-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

"Markers of Bone Formation:~Serum Procollagen type 1 amino- terminal propeptide (P1NP)~Serum Osteocalcin (OC)~Serum Bone-specific alkaline phosphatase (BALP)~Markers of Bone Resorption:~- Serum C-telopeptides of collagen cross-links (CTX)" (NCT01387672)
Timeframe: 3 months

Headache

Intervention	Percent change from baseline (Mean)
	P1NP	OC	BALP	CTX
0.3 Sublingual (Nitrostat 1) - Treatment Arm 4	-6.126	1.046	-7.000	-0.666
0.6 Sublingual (Nitrostat 2) - Treatment Arm 5	2.941	1.033	-3.686	-1.380
ISMO - Treatment Arm 1	-4.627	-3.244	-5.023	-5.844
Ointment (Nitrol) - Treatment Arm 3	-4.297	-4.481	-7.426	-9.699
Patch (Nitro-Dur) - Treatment Arm 2	-0.405	3.796	-0.541	-1.025
Placebo Ointment - Treatment Arm 6	-1.635	4.247	-1.648	-1.783

"Severity of headaches. Subjects recorded the severity of headaches upon awakening every day during the run-in phase using a visual analogue scale (VAS). The scale is represented by a line (continuum) 10 cm long. Subjects were asked to make a vertical line along the continuum to indicate the severity of their headache each morning upon awakening. The score is recorded in cm from 0 to 10. A vertical line marked at 0 means no headache (score recorded = 0), a vertical line marked at 10 means a terrible headache (score recorded = 10)." (NCT01387672)
Timeframe: Run-in phase - 2 days

Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension

Intervention	score on a scale (Mean)
	ISMO	Patch	Ointment	0.3 Sublingual	0.6 Sublingual
Run-in Phase	2.1	3.1	1.5	0.36	0.6

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. (NCT00498186)
Timeframe: Up to five years

Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.

Intervention	participants (Number)
Rotigotine	93